Senior Engineer, Facilities & Maintenance CLT

Senior Engineer, Facilities & Maintenance CLT Join to apply for the Senior Engineer, Facilities & Maintenance CLT role at BioSpaceSenior Engineer, Facilities & Maintenance CLT 16 hours ago Be among the first 25 applicantsJoin to apply for the Senior Engineer, Facilities & Maintenance CLT role at BioSpaceGet AI-powered advice on this job and more exclusive features.About The DepartmentAt Novo Nordisk, we want to make a difference. For more than 100 years, we have led the way in diabetes care. Being part of Novo Nordisk allows our employees to embark on life-changing careers, and the opportunity to help improve the quality of life for millions of people around the world.About The DepartmentAt Novo Nordisk, we want to make a difference. For more than 100 years, we have led the way in diabetes care. Being part of Novo Nordisk allows our employees to embark on life-changing careers, and the opportunity to help improve the quality of life for millions of people around the world.Our Bloomington, Indiana site is a state-of-the-art facility where we have an integrated model from process and formulation to clinical and commercial biomanufacturing and drug product fill/finish and packaging. The Bloomington campus is a recognized facility where talented teams work with innovators to help develop, manufacture and supply products to patients around the world.What We Offer YouLeading pay and annual performance bonus for all positionsAll employees enjoy generous paid time off including 14 paid holidaysHealth Insurance, Dental Insurance, Vision Insurance – effective day oneGuaranteed 8% 401K contribution plus individual company match optionFamily Focused Benefits including 14 weeks paid parental & 6 weeks paid family medical leaveFree access to Novo Nordisk-marketed pharmaceutical productsTuition AssistanceLife & Disability InsuranceEmployee Referral AwardsAt Novo Nordisk, you will find opportunities, resources, and mentorship to help grow and build your career. Are you ready to realize your potential? Join Team Novo Nordisk and help us make what matters.Facility Engineering: is responsible for improving processes and systems associated with the facility, in a way that ensures the safety of the employees and public, ensures compliance (quality, safety, and statutory), and improves physical asset readiness and lifetime through projects and continuous improvement of maintenance and calibration plans. Facility Engineering puts programs, designs, processes, and systems in place for the facility and associated systems/utilities to expand, extend, or enhance their design/commissioned/validated state.RelationshipsReports to: Sr. Manager, Engineering, FacilitiesEssential FunctionsGeneral Engineering Skills:Effectively document work performed following required documentation practicesBe available and respond to site as part of the on-call rotation (optional for Calibration)Escort and supervise contractors through facility for routine inspections or repairs, ensuring they complete activities per procedure or agreementsDraft SOPs for building operation, maintenance, and calibrationProvide engineering guidance and execution on facilities and equipment projectsSupport Maximo/Trackwise (CM/CMR/CC) workflowDevelop standard processes to evaluate future capital projectsUse hand tools, power tools, and delicate testing equipment in performance of dutiesComplete non-routine repair work orders for regulated and unregulated systemsIdentify and implement improvement opportunities for established production systemsFile and maintain controlled documentsWill act as a technical resource within own work group/project teamCollaborate significantly with cross functional groups including Validation, Quality Control, Manufacturing, Process Development, and FacilitiesManage any CAPAs assigned pertaining to single technology lanesAssist in responding to customer/regulatory audit observations and corrective actionsReview and approve changes to computerized automation production and laboratory systemsPerform advanced troubleshooting as it relates to assigned job dutiesProvide technical assistance and training for personnelInteract with other departments to schedule activities around the production schedules of the cGMP Manufacturing and Process Development departmentsApply advanced knowledge of the principles, theories and concepts applicable to a wide range of work in a discipline and broad knowledge of principles and concepts in other disciplinesApply technical and functional knowledge to assist in experiment/project design that will enable department/group/team to meet goalsWork independently on a broad range of difficult problemsDrive new, innovative solutions to problemsComplete at-risk mitigation for functionUse judgment within generally defined guidelines to identify solutions to problemsIdentify improvements and efficiencies of preventative maintenanceOther duties as assignedAutomation/Facility Automation/Reliability Engineering SkillsAct as key Subject Matter Expert (SME) for automation design, systems integration and CSV (Automation Only)Apply and enhance existing automation validation methods and templates for the qualification of new and existing production and laboratory automated systems, including major capital projects and continuous improvement of systemsSupports development and qualification of SCADA applicationsDemonstrated competency in ladder-logic, function block diagrams, structured text, and S88 batch (procedural control) programmingSupport the multi-use manufacturing facility, including BMS and HVAC systemsBio-containment systems (Automation and Reliability Only)Utility Systems (critical and non-critical) (Automation Only)Monitor, maintain, and repair existing production and laboratory control and monitoring systems (PLC, HMI, automation/controls applications, device networks, application software, etc.)Apply and enhance existing automation validation programs for the validation of new and existing production and laboratory automated systems, including major capital projects and continuous improvement of systemsDraft, review, execute, and approve protocols and summary reports related to Automation System Validation (CSV)..Review and approve changes to computerized automation production and laboratory systems through the change control program to assess impact on validated systemsCollaborate significantly with cross functional groups including Validation, Quality Control, Process Engineering, Manufacturing, Process Development, and FacilitiesWork with local and global IT to implement projects related to integration and networkingUtilize software and hardware support agreements to ensure compliance and minimize cost impact. Manage third party contractors who may work on Catalent systems.Physical RequirementsFrequent sitting, standing, walking, reading of written documents and use of computer monitor screen, reaching with hands and arms, talking, writing, listening. Occasional stooping, kneeling, crouching, bending, carrying, grasping. Frequent lifting and/or moving up to 30 pounds and occasional lifting and/or moving up to 50 pounds. Must comply with EHS responsibilities for the position. Working conditions will be heating ventilation and air condition controlled. Working in a lab environment will require working with skin irritants, lung irritants, electrical equipment, sharp instruments, toxic materials, and hazardous waste. Safety procedures will be followed to minimize exposure, including clean room gowning. May be exposed to inclement weather or be required to work in environments or under conditions that require the use of protective gear and/or awareness of personal safety and safety of others.QualificationsEducation/Experience:Bachelor's degree in chemical/mechanical/electrical engineering or appropriate scientific discipline, with 5-8 years of relevant experience, requiredMaster's degree, preferredPE / Registered Engineer in training, preferredOSHA/IOSH/NeBOSH Certification or equivalent, preferred5+ years Project Engineering relevant experience, preferred2+ years within the pharmaceutical or biotechnology industry with a focus on sterile biologics manufacturing, inspection and/or packaging preferredHighly skilled and/or certified in multiple tradesMust be able to read and understand English-written job instructions and safety requirementsTechnical Requirements:Ability to use Excel, Word, and other office systemsStrong understanding of cGMP regulations, FDA guidelines, and industry standards related to clean utilities, sterile manufacturing, inspection and packagingFlexibility to adapt to changing priorities and deadlines in a fast-paced manufacturing environmentAbility to formulate complex and comprehensive materials such as authoritative reports and/or to create/deliver formal and informal presentationsAbility to cross-train on techniques across multiple groupsAbility to independently interpret data, analyze trends, and provide insight into potential issues and subsequent solutionsAbility to complete investigation, deviation, and change control forms independentlyProficient in operation and troubleshooting of a wide variety of instrumentation and data systemsAbility to provide ideas, introduce new technology, and drive process improvements. Work with other groups to develop, qualify, and transfer methods accordinglyUnderstanding and adherence to applicable regulatory authority and guidelinesWrite, edit, and review SOPsExposure to contractual management and processesProblem–solving (Lean Six Sigma) and change management methodologies consistent with establishing a culture of continuous improvement is preferredTeam leadership and project-management skillsUnderstanding of proposal and project scope as it relates to pricing, resources management, and the impact on businessAbility to operate within a clean room environmentBehavioural Requirements:Ability to see and hear, read, and write clear EnglishRequires adaptability, analysing, assessing, calculating, decision making, dependability, good judgment, reading, memorizing, social skills, speaking, stress control, writingAbility to communicate effectively and follow/retain detailed written and verbal instruction in an accurate, timely, safe, and professional manner with supervisor, group members, and other departments as necessary, in a professional and accurate mannerAbility to manage time effectively to complete assignments in expected time frame and independently seek out additional work when tasks are completed ahead of timeAbility to cooperate with coworkers within an organized team environment or work aloneDetail oriented with ability to work effectively under high pressure with multiple deadlinesStrong ability to multi-task in a fast-paced environmentPositive attitude and ability to work with othersAbility to process a large volume of workAbility to effectively carry out and implement changeAbility to put aside personal opinions and focus on business needs, department needs, or group needsLeadership Requirements:Ability to organize and prioritize work schedules of others on short and long-term basis, including integrating timelines and meeting milestones for successful project completionWe commit to an inclusive recruitment process and equality of opportunity for all our job applicants.At Novo Nordisk we recognize that it is no longer good enough to aspire to be the best company in the world. We need to aspire to be the best company for the world and we know that this is only possible with talented employees with diverse perspectives, backgrounds and cultures. We are therefore committed to creating an inclusive culture that celebrates the diversity of our employees, the patients we serve and communities we operate in. Together, we're life changing.Novo Nordisk is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to race, ethnicity, color, religion, sex, gender identity, sexual orientation, national origin, disability, protected veteran status or any other characteristic protected by local, state or federal laws, rules or regulations.If you are interested in applying to Novo Nordisk and need special assistance or an accommodation to apply, please call us at 1-855-411-5290. This contact is for accommodation requests only and cannot be used to inquire about the status of applications.Seniority level Seniority level Mid-Senior levelEmployment type Employment type Full-timeJob function Job function Management and ManufacturingIndustries Internet NewsReferrals increase your chances of interviewing at BioSpace by 2xSign in to set job alerts for “Maintenance Engineer” roles. 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