Lead Manufacturing Engineer - Value Engineering Cook GroupLead Manufacturing Engineer - Value EngineeringBloomington, IndianaFull timeThe Manufacturing Engineer works with Operations, Quality Assurance and Regulatory Affairs to improve existing product designs and processes to increase throughput, decrease operational costs, or improve quality. Overview: The Manufacturing Engineer plans, directs, and coordinates manufacturing processes for medical device products, and supports Operations in a way to assure a quality product is produced in a timely manner.
Lead Manufacturing Engineer Value Engineering Cook Medical LLCLead Manufacturing Engineer Value EngineeringBloomington, INPreferred Experience: • Experience with value-stream mapping • Experience with Lean and/or Six Sigma and corresponding certification• Experience with Kaizen/Continuous Improvement and corresponding certification• Experience in leading major cost savings efforts in manufacturing (via process and/or design changes).Physical The Manufacturing Engineer works with Operations, Quality Assurance and Regulatory Affairs to improve existing product designs and processes to increase throughput, decrease operational costs, or improve quality.
Manufacturing Science and Technology (MSAT) Simtra BioPharma SolutionsManufacturing Science and Technology (MSAT)Bloomington, IndianaIn-depth knowledge of systems and equipment - including scales, mixing systems and mixing monitoring methods, aseptic formulations, fill volume limit setting, disposable formulation technology, homogeneity testing, control charting, identification and response to trends. Lead the onboarding and process development activities for the manufacture of new drug products, including the supporting development studies Lead the cross-functional team through technical activities, development studies and PPQ batches.
Manufacturing Group Leader - Maintenance - Bedford GMManufacturing Group Leader - Maintenance - BedfordBedford, IndianaCandidates must possess technical expertise to oversee and support maintenance operations, exercising independent judgment within the framework of Global Manufacturing Systems, with a focus on Safety, People, Quality, Responsiveness, Cost, and Environment (SPQRCE). This includes direct company sponsorship, entry of GM as the immigration employer of record on a government form, and any work authorization requiring a written submission or other immigration support from the company (e.g., H1-B, OPT, STEM OPT, CPT, TN, J-1, etc).
Manufacturing Group Leader - Temporary Summer Help General Motors CoManufacturing Group Leader - Temporary Summer HelpBedford, INOur vision is a world with Zero Crashes, Zero Emissions, and Zero Congestion, and we embrace the responsibility to lead the change that will make our world better, safer, and more equitable for all. You will be responsible for coordinating and leading daily team activities to achieve business metrics using GM tools and processes as it relates to material flow.
Manufacturing Group Leader - Maintenance - Bedford General Motors CoManufacturing Group Leader - Maintenance - BedfordINCandidates must possess technical expertise to oversee and support maintenance operations, exercising independent judgment within the framework of Global Manufacturing Systems, with a focus on Safety, People, Quality, Responsiveness, Cost, and Environment (SPQRCE). This includes direct company sponsorship, entry of GM as the immigration employer of record on a government form, and any work authorization requiring a written submission or other immigration support from the company (e.g., H1-B, OPT, STEM OPT, CPT, TN, J-1, etc).
Sr. Manufacturing Engineer - Value Engineering Cook GroupSr. Manufacturing Engineer - Value EngineeringBloomington, IndianaFull timeThe Manufacturing Engineer works with Operations, Quality Assurance and Regulatory Affairs to improve existing product designs and processes to increase throughput, decrease operational costs, or improve quality. Overview: The Manufacturing Engineer plans, directs, and coordinates manufacturing processes for medical device products, and supports Operations in a way to assure a quality product is produced in a timely manner.
Manufacturing Engineer 2 Cook GroupManufacturing Engineer 2Bloomington, IndianaFull timeThe Manufacturing Engineer works with Operations, Quality Assurance and Regulatory Affairs to improve existing product designs and processes to increase throughput, decrease operational costs, or improve quality. Overview: The Manufacturing Engineer 2 plans, directs, and coordinates manufacturing processes for medical device products, and supports Operations in a way to assure a quality product is produced in a timely manner.
Manufacturing Systems Specialist 1 Cook Medical LLCManufacturing Systems Specialist 1Bloomington, INworkflows, material lists, electronic signatures) for both prototype demonstrations and system testing• Troubleshoot customer issues - Provide timely, accurate, and friendly support to the customer base, both internal and external - Reproduce issues in-house if necessary for troubleshooting and testing - Provide Internal support - Assist internal consulting, training and education resources as requested• Documentation - Create knowledge base with "self-help" troubleshooting and provide answers to common situations / errors - Assist with maintaining any relevant procedures for job functions• Use independent judgment to make decisions on significant issues• Run short term, long-term, and/or design focused projects, or complete significant tasks critical to projects• Serve as a mentor, trainer, and resource to the department for aspects critical to performing job functions• Prioritize work based on assigned goals• Maintain and increase knowledge related to the team's focus and relevant company systems. Associates degree or Bachelor''s degree in a technical field preferred; equivalent industry experience acceptable• 2 years experience that relates directly to the above essential job functions/duties• Experience working independently and with minimal supervision • Basic knowledge/experience with analytical testing equipment preferred• Working knowledge of word processing, spreadsheet, and PP presentation software preferred.
Sr. Manufacturing Engineer Value Engineering Cook Medical LLCSr. Manufacturing Engineer Value EngineeringBloomington, INThe Manufacturing Engineer works with Operations, Quality Assurance and Regulatory Affairs to improve existing product designs and processes to increase throughput, decrease operational costs, or improve quality. The Manufacturing Engineer plans, directs, and coordinates manufacturing processes for medical device products, and supports Operations in a way to assure a quality product is produced in a timely manner.
Manufacturing Engineer C/B/A NSK LtdManufacturing Engineer C/B/AFranklin, INNSK Corporation is looking for a Mechanical Engineer to design, integrate, or improve manufacturing systems or related processes and work with cross-functional teams to refine product designs to increase producibility and decrease costs. We are always looking for ambitious team players who have the desire to work their way up the ladder, succeed, and make improvements to our products, but also to our community, the environment and themselves.
Manufacturing Engineer 2 Cook Medical LLCManufacturing Engineer 2Bloomington, INThe Manufacturing Engineer works with Operations, Quality Assurance and Regulatory Affairs to improve existing product designs and processes to increase throughput, decrease operational costs, or improve quality. The Manufacturing Engineer 2 plans, directs, and coordinates manufacturing processes for medical device products, and supports Operations in a way to assure a quality product is produced in a timely manner.
Quality Engineer 1, Manufacturing Cook GroupQuality Engineer 1, ManufacturingBloomington, IndianaFull timeDrive continuous improvement efforts through facilitating, leading, and collaborating with cross function teams including quality, engineering, production, clinical, and regulatory affairs. Overview: The Quality Engineer at Cook Inc. serves as the lead quality representative of certain product lines within product development, manufacturing, post-market surveillance, and/or CAPA.
Quality Engineer 2, Manufacturing Cook GroupQuality Engineer 2, ManufacturingBloomington, IndianaFull timeDrive continuous improvement efforts through facilitating, leading, and collaborating with cross function teams including quality, engineering, production, clinical, and regulatory affairs. Overview: The Quality Engineer at Cook Inc. serves as the lead quality representative of certain product lines within product development, m Next anufacturing, post-market surveillance, and/or CAPA.
Quality Engineer 2, Manufacturing Cook Medical LLCQuality Engineer 2, ManufacturingBloomington, INqualification, process capability, sampling plans, validation, etc.) • Perform investigation of product nonconformance/complaints, root cause analysis, monitoring/trending of process and product, and escalation of identified issues • Plan, review, and approve change requests • Execute risk assessment as needed and facilitate development and completion of risk file documentation • Conduct Risk-based decision making and effective resolution of issues • Lead or support CAPAs as necessary • May interface with internal or 3rd party audits (e.g. FDA, Notified Body, etc.) • Drive continuous improvement efforts through facilitating, leading, and collaborating with cross function teams including quality, engineering, production, clinical, and regulatory affairs.
Quality Engineer 1, Manufacturing Cook Medical LLCQuality Engineer 1, ManufacturingBloomington, INqualification, process capability, sampling plans, validation, etc.) • Perform investigation of product nonconformance/complaints, root cause analysis, monitoring/trending of process and product, and escalation of identified issues • Plan, review, and approve change requests • Execute risk assessment as needed and facilitate development and completion of risk file documentation • Conduct Risk-based decision making and effective resolution of issues • Lead or support CAPAs as necessary • May interface with internal or 3rd party audits (e.g. FDA, Notified Body, etc.) • Drive continuous improvement efforts through facilitating, leading, and collaborating with cross function teams including quality, engineering, production, clinical, and regulatory affairs.
Manufacturing Supervisor, 3rd Shift Simtra US LLCManufacturing Supervisor, 3rd ShiftBloomington, INWith facilities in Bloomington, Indiana, US and Halle/Westfalen, Germany, we offer a wide range of delivery systems including pre-filled syringes, liquid/lyophilized vials, diluents for reconstitution, powder-filled vials and sterile crystallization. Our product types include biologics and small molecules, cytotoxics, highly potent compounds, diluents for reconstitution and vaccines - which are all directly injected into patients worldwide.
Pharmaceutical Manufacturing Manager, (2nd Shift) Simtra BioPharma SolutionsPharmaceutical Manufacturing Manager, (2nd Shift)Bloomington, IndianaThe manager will lead, organize, and manage personnel and activities in all manufacturing activities under cGMP regulations, to serve as the primary contact for manufacturing related communications on the shift, and to provide guidance to the leadership team to ensure consistent execution and improvement of the manufacturing process. With facilities in Bloomington, Indiana, US and Halle/Westfalen, Germany, we offer a wide range of delivery systems including pre-filled syringes, liquid/lyophilized vials, diluents for reconstitution, powder-filled vials and sterile crystallization.
Pharmaceutical Manufacturing Manager, (3rd Shift) Simtra BioPharma SolutionsPharmaceutical Manufacturing Manager, (3rd Shift)Bloomington, IndianaThe manager will lead, organize, and manage personnel and activities in all manufacturing activities under cGMP regulations, to serve as the primary contact for manufacturing related communications on the shift, and to provide guidance to the leadership team to ensure consistent execution and improvement of the manufacturing process. With facilities in Bloomington, Indiana, US and Halle/Westfalen, Germany, we offer a wide range of delivery systems including pre-filled syringes, liquid/lyophilized vials, diluents for reconstitution, powder-filled vials and sterile crystallization.
Pharmaceutical Manufacturing Manager, Weekend PM Simtra BioPharma SolutionsPharmaceutical Manufacturing Manager, Weekend PMBloomington, IndianaThe manager will lead, organize, and manage personnel and activities in all manufacturing activities under cGMP regulations, to serve as the primary contact for manufacturing related communications on the shift, and to provide guidance to the leadership team to ensure consistent execution and improvement of the manufacturing process. With facilities in Bloomington, Indiana, US and Halle/Westfalen, Germany, we offer a wide range of delivery systems including pre-filled syringes, liquid/lyophilized vials, diluents for reconstitution, powder-filled vials and sterile crystallization.
Pharmaceutical Manufacturing Supervisor, (2nd Shift) Simtra BioPharma SolutionsPharmaceutical Manufacturing Supervisor, (2nd Shift)Bloomington, IndianaWith facilities in Bloomington, Indiana, US and Halle/Westfalen, Germany, we offer a wide range of delivery systems including pre-filled syringes, liquid/lyophilized vials, diluents for reconstitution, powder-filled vials and sterile crystallization. Our product types include biologics and small molecules, cytotoxics, highly potent compounds, diluents for reconstitution and vaccines – which are all directly injected into patients worldwide.
Pharmaceutical Manufacturing Manager, Weekend PM Simtra US LLCPharmaceutical Manufacturing Manager, Weekend PMBloomington, INPhysical / safety requirements: Ability to stand for extended periods of time Physical coordination/flexibility to allow gowning for clean room environments Utilize applicable personal protective equipment, including safety shoes/toe caps, gloves, eye protection, heat resistant wear and hearing protection Dexterity and physical condition to perform some level of repetitive motion tasks Ability to wear respirator usage when product or task requires Duties may require overtime work, including nights and weekends Use of hands and fingers to manipulate office equipment is required Must be able to gown qualify for Grade A/B areas (filling) Position may require sitting for long hours. Lean Manufacturing experience required (i.e. value stream mapping, leading kaizen events to drive positive change on the floor, and teaching people to think) Computer proficiency in Microsoft Word, Excel, and Outlook and the ability to use enterprise software (examples include: JDE, BPLM, MAXIMO, Trackwise, etc.).
Pharmaceutical Manufacturing Manager, 3rd Shift Simtra US LLCPharmaceutical Manufacturing Manager, 3rd ShiftBloomington, INThe manager will lead, organize, and manage personnel and activities in all manufacturing activities under cGMP regulations, to serve as the primary contact for manufacturing related communications on the shift, and to provide guidance to the leadership team to ensure consistent execution and improvement of the manufacturing process. With facilities in Bloomington, Indiana, US and Halle/Westfalen, Germany, we offer a wide range of delivery systems including pre-filled syringes, liquid/lyophilized vials, diluents for reconstitution, powder-filled vials and sterile crystallization.
Pharmaceutical Manufacturing Supervisor, 2nd Shift Simtra US LLCPharmaceutical Manufacturing Supervisor, 2nd ShiftBloomington, INDesirable qualifications: • Bachelors Degree in a science, engineering, or business discipline strongly preferred • High School diploma or GED required • Minimum 2 years of manufacturing or operations support experience required • Minimum 1 year leadership experience required • Computer proficiency in Microsoft Word, Excel, and Outlook and the ability to use enterprise software (examples include: Microsoft Dynamics, Veeva, PowerBI, Trackwise, etc.) • Physical / safety requirements: • Ability to stand or sit for extended periods of time • Ability to lift up to 50 pounds • Ability to push/pull heavy wheeled objects (i.e. tanks, carts, pallet jacks, etc.) • Must be able to perform overhead work (i.e. sanitizing walls and ceilings) • Physical coordination/flexibility to allow gowning for clean room environments • Use applicable personal protective equipment, including safety shoes/toe caps, gloves, eye protection, heat resistant wear and hearing protection • Dexterity and physical condition to perform some level of repetitive motion tasks • Ability to wear respirator usage when product or task requires • Eyesight to ensure effective inspection of equipment and/or filled units (corrective lenses acceptable) • Use of hands and fingers to manipulate office equipment is required • Must be able to gown qualify for Grade A/B areas (filling). With facilities in Bloomington, Indiana, US and Halle/Westfalen, Germany, we offer a wide range of delivery systems including pre-filled syringes, liquid/lyophilized vials, diluents for reconstitution, powder-filled vials and sterile crystallization.
Logistics Manager - Manufacturing Amrize LtdLogistics Manager - ManufacturingFranklin, IN$95,000–$125,000 / yearEmployees who are required to wear respirators must be clean-shaven where the respirator seal meets the face in order to pass the qualitative and quantitative fit tests. Supervises the unloading/loading of raw and finished goods and is responsible for good communication between material suppliers, plant personnel, and customers.
Aseptic Manufacturing Risk Management Associate II Simtra BioPharma SolutionsAseptic Manufacturing Risk Management Associate IIBloomington, IndianaThe Technical Services Associate II (Risk Management) is responsible for risk management activities associated with non-conformances, complaints, equipment validation, qualification and change control activities at the BPS site. With facilities in Bloomington, Indiana, US and Halle/Westfalen, Germany, we offer a wide range of delivery systems including pre-filled syringes, liquid/lyophilized vials, diluents for reconstitution, powder-filled vials and sterile crystallization.
Principal Manufacturing Science and Technology (MSAT) Representative Simtra BioPharma SolutionsPrincipal Manufacturing Science and Technology (MSAT) RepresentativeBloomington, IndianaRequires in depth knowledge of systems and equipment, including: scales, mixing systems and mixing monitoring methods, aseptic formulations, fill volume limit setting, disposable formulation technology, homogeneity testing, control charting, identification and response to trends. The Principal Manufacturing Science and Technology (MSAT) Representative is part of a team of experienced pharmaceutical professionals responsible for the technical onboarding and process development of new drug product projects at Sintra BPS.
Pharmaceutical Manufacturing Manager, 2nd Shift Simtra US LLCPharmaceutical Manufacturing Manager, 2nd ShiftBloomington, INThe manager will lead, organize, and manage personnel and activities in all manufacturing activities under cGMP regulations, to serve as the primary contact for manufacturing related communications on the shift, and to provide guidance to the leadership team to ensure consistent execution and improvement of the manufacturing process. With facilities in Bloomington, Indiana, US and Halle/Westfalen, Germany, we offer a wide range of delivery systems including pre-filled syringes, liquid/lyophilized vials, diluents for reconstitution, powder-filled vials and sterile crystallization.
2027 Summer Corporate Intern- Manufacturing Caterpillar Inc2027 Summer Corporate Intern- ManufacturingFranklin, IN$25–$43 / hourInternship Program Qualifications: Must be enrolled full-time in a 4-year university/college in one of the following degree programs: Engineering, Engineering Management/Technology, Industrial Distribution/Technology, Automation Engineering Technology, Mechatronics, Robotics, Mechanical Engineering, Electrical Engineering, or other relevant degrees at the time of application and throughout the program. You'll join a team with diverse project responsibilities and have experiences including (but not limited to): Manufacturing Engineering : Responsible and accountable for enhancements and modifications to equipment and processes in our facilities, monitoring equipment and process reliability, identifying and addressing problem areas and providing engineering support on equipment, processes, or facilities.
Senior Quality Manufacturing Engineer Cook GroupSenior Quality Manufacturing EngineerBloomington, IndianaFull timeDrive continuous improvement efforts through facilitating, leading, and collaborating with cross function teams including quality, engineering, production, clinical, and regulatory affairs. - Perform investigation of product non-conformance/complaints, root cause analysis, monitoring/trending of process and product, and escalation of identified issues.
Lead Automation Controls Engineer GMLead Automation Controls EngineerBedford, IndianaThis person will serve as a hands-on technical lead who can solve complex manufacturing problems, guide project execution, and support the successful deployment of new equipment and process improvements in a fast-paced plant and manufacturing engineering environment. Core Responsibilities Lead the controls and automation scope for new equipment, major upgrades, and continuous improvement projects, with responsibility across controls, robotics, cobots, and machine vision applications.
Lead Automation Controls Engineer General Motors CoLead Automation Controls EngineerINThis person will serve as a hands-on technical lead who can solve complex manufacturing problems, guide project execution, and support the successful deployment of new equipment and process improvements in a fast-paced plant and manufacturing engineering environment. Lead the controls and automation scope for new equipment, major upgrades, and continuous improvement projects, with responsibility across controls, robotics, cobots, and machine vision applications.
Production Team Lead/ Unit Coordinator C - 3rd Shift NSK LtdProduction Team Lead/ Unit Coordinator C - 3rd ShiftFranklin, INQualifications: This job requires a high school diploma or equivalent and 4 to 6 years of position-related experience; the preferred formal education is a Technical Diploma or associate degree and 6 to 8 years of position-related experience. Read and analyze charts, work orders, production schedules, and other records and reports to determine production requirements and to evaluate current production estimates and outputs.
Aseptic Equipment Lead (2nd Shift) Simtra BioPharma SolutionsAseptic Equipment Lead (2nd Shift)Bloomington, IndianaBecome the subject‑matter expert for your assigned filling line—whether syringe or vial equipment—and its supporting systems such as component washers, depyrogenation tunnels, filling and stoppering machines, cappers, tray loaders, and lyophilizer loading/unloading systems. With facilities in Bloomington, Indiana, US and Halle/Westfalen, Germany, we offer a wide range of delivery systems including pre-filled syringes, liquid/lyophilized vials, diluents for reconstitution, powder-filled vials and sterile crystallization.
Aseptic Equipment Lead (Weekend PM) Simtra BioPharma SolutionsAseptic Equipment Lead (Weekend PM)Bloomington, IndianaBecome the subject‑matter expert for your assigned filling line—whether syringe or vial equipment—and its supporting systems such as component washers, depyrogenation tunnels, filling and stoppering machines, cappers, tray loaders, and lyophilizer loading/unloading systems. With facilities in Bloomington, Indiana, US and Halle/Westfalen, Germany, we offer a wide range of delivery systems including pre-filled syringes, liquid/lyophilized vials, diluents for reconstitution, powder-filled vials and sterile crystallization.
Aseptic Equipment Lead (3rd Shift) Simtra BioPharma SolutionsAseptic Equipment Lead (3rd Shift)Bloomington, IndianaBecome the subject‑matter expert for your assigned filling line—whether syringe or vial equipment—and its supporting systems such as component washers, depyrogenation tunnels, filling and stoppering machines, cappers, tray loaders, and lyophilizer loading/unloading systems. With facilities in Bloomington, Indiana, US and Halle/Westfalen, Germany, we offer a wide range of delivery systems including pre-filled syringes, liquid/lyophilized vials, diluents for reconstitution, powder-filled vials and sterile crystallization.
Aseptic Equipment Lead (Weekend AM) Simtra BioPharma SolutionsAseptic Equipment Lead (Weekend AM)Bloomington, IndianaBecome the subject‑matter expert for your assigned filling line—whether syringe or vial equipment—and its supporting systems such as component washers, depyrogenation tunnels, filling and stoppering machines, cappers, tray loaders, and lyophilizer loading/unloading systems. With facilities in Bloomington, Indiana, US and Halle/Westfalen, Germany, we offer a wide range of delivery systems including pre-filled syringes, liquid/lyophilized vials, diluents for reconstitution, powder-filled vials and sterile crystallization.
Welding Lead Science Applications International CorpWelding LeadBedford, INAct as the subject matter expert (SME) for projects welding and fabrication activities, resolving technical challenges and training team members to encourage skill growth and quality assurance. Collaborate with the program team to analyze technical documentation including drawings, schematics, and layouts, ensuring practical alignment with welding processes for production.
Aseptic Equipment Lead Weekend AM Simtra US LLCAseptic Equipment Lead Weekend AMBloomington, INThe responsibilities: Become the subject‑matter expert for your assigned filling line-whether syringe or vial equipment-and its supporting systems such as component washers, depyrogenation tunnels, filling and stoppering machines, cappers, tray loaders, and lyophilizer loading/unloading systems. With facilities in Bloomington, Indiana, US and Halle/Westfalen, Germany, we offer a wide range of delivery systems including pre-filled syringes, liquid/lyophilized vials, diluents for reconstitution, powder-filled vials and sterile crystallization.
Aseptic Equipment Lead 3rd Shift Simtra US LLCAseptic Equipment Lead 3rd ShiftBloomington, INThe responsibilities: Become the subject‑matter expert for your assigned filling line-whether syringe or vial equipment-and its supporting systems such as component washers, depyrogenation tunnels, filling and stoppering machines, cappers, tray loaders, and lyophilizer loading/unloading systems. With facilities in Bloomington, Indiana, US and Halle/Westfalen, Germany, we offer a wide range of delivery systems including pre-filled syringes, liquid/lyophilized vials, diluents for reconstitution, powder-filled vials and sterile crystallization.
Instrumentation and Calibration Lead Jones Lang LaSalle IncInstrumentation and Calibration LeadBloomington, INThis position is perfect for an experienced calibration technician ready to advance into leadership-you'll spend 60-70% of your time performing complex calibrations and troubleshooting critical systems, while dedicating 30-40% to mentoring your team and coordinating work activities. Oversee and coordinate daily activities of 2-4 instrumentation technicians by assigning work tasks, reviewing completed calibrations for accuracy, and providing hands-on coaching and technical guidance.
Formulation Group Lead - Shift 2 Simtra US LLCFormulation Group Lead - Shift 2Bloomington, INWith facilities in Bloomington, Indiana, US and Halle/Westfalen, Germany, we offer a wide range of delivery systems including pre-filled syringes, liquid/lyophilized vials, diluents for reconstitution, powder-filled vials and sterile crystallization. This position fully supports and drives quality operations on the production floor and communicates effectively with production team members, multiple levels of management, and other customer support departments.
NewLead Service Technician-Indiana/Illinois George E. Booth Co.Lead Service Technician-Indiana/IllinoisGreenwood, INThe Lead Service Technician is responsible for providing hands-on field service execution, as well as technical leadership in the field of process control instrumentation, gas detection, and valves. This role combines senior-level technical expertise with mentoring and training responsibilities to support and develop the technical team while maintaining a significant presence in field operations.
Validation Lead/Associate III, Commissioning Qualification, Validation Simtra BioPharma SolutionsValidation Lead/Associate III, Commissioning Qualification, ValidationBloomington, IndianaWith facilities in Bloomington, Indiana, US and Halle/Westfalen, Germany, we offer a wide range of delivery systems including pre-filled syringes, liquid/lyophilized vials, diluents for reconstitution, powder-filled vials and sterile crystallization. Our product types include biologics and small molecules, cytotoxics, highly potent compounds, diluents for reconstitution and vaccines – which are all directly injected into patients worldwide.
Test Lead Engineer Ukpeagvik Inupiat CorpTest Lead EngineerINManage and maintain test schedules that identify all tasks required to execute the test effort, establish start and finish dates of required tasks, allocate the necessary resources, and maximize efficiency of test assets and facilities to ensure program milestones and project deadlines are being met. The Test Lead Engineer Responsible for leading and coordinating test efforts for evaluating and qualifying shipboard equipment in support of Strategic Systems Programs (SSP) to ensure components can withstand shipboard environments.
Validation Lead/Associate III, Commissioning Qualification, Validation Simtra US LLCValidation Lead/Associate III, Commissioning Qualification, ValidationBloomington, INWith facilities in Bloomington, Indiana, US and Halle/Westfalen, Germany, we offer a wide range of delivery systems including pre-filled syringes, liquid/lyophilized vials, diluents for reconstitution, powder-filled vials and sterile crystallization. Our product types include biologics and small molecules, cytotoxics, highly potent compounds, diluents for reconstitution and vaccines - which are all directly injected into patients worldwide.
Senior Technical Transfer Associate Simtra US LLCSenior Technical Transfer AssociateBloomington, INIn-depth knowledge of systems and equipment - including scales, mixing systems and mixing monitoring methods, aseptic formulations, fill volume limit setting, disposable formulation technology, homogeneity testing, control charting, identification and response to trends. Create technical transfer documents supporting this goal [Technical Transfer Plan, Process Development studies (i.e. mixing studies, filtration studies, purge studies, etc.), Demonstration batch records, PPQ master batch record].
Sr. Process Validation Engineer Simtra BioPharma SolutionsSr. Process Validation EngineerBloomington, IndianaThe Senior Process Validation Engineer partners closely with Manufacturing, Quality, Validation, Engineering, Tech Transfer, Supply Chain, and Regulatory teams to implement risk‑based approach that support safe, reliable, and scalable sterile drug product manufacturing. The Senior Process Validation Engineer is a key member of the Technical Services organization, responsible for leading and supporting validation activities for sterile injectable manufacturing processes within a regulated pharmaceutical CDMO environment.
Sr. Process Validation Engineer Simtra US LLCSr. Process Validation EngineerBloomington, INThe Senior Process Validation Engineer partners closely with Manufacturing, Quality, Validation, Engineering, Tech Transfer, Supply Chain, and Regulatory teams to implement risk‑based approach that support safe, reliable, and scalable sterile drug product manufacturing. This role: The Senior Process Validation Engineer is a key member of the Technical Services organization, responsible for leading and supporting validation activities for sterile injectable manufacturing processes within a regulated pharmaceutical CDMO environment.
NewMSAT Senior Associate (Tech Transfer) Simtra BioPharma SolutionsMSAT Senior Associate (Tech Transfer)Bloomington, IndianaRequires in depth knowledge of systems and equipment, including: scales, mixing systems and mixing monitoring methods, aseptic formulations, fill volume limit setting, disposable formulation technology, homogeneity testing, control charting, identification and response to trends. With facilities in Bloomington, Indiana, US and Halle/Westfalen, Germany, we offer a wide range of delivery systems including pre-filled syringes, liquid/lyophilized vials, diluents for reconstitution, powder-filled vials and sterile crystallization.