Manufacturing Engineer JobotManufacturing EngineerColumbus, IN$90,000–$115,000 / yearInformation collected and processed as part of your Jobot candidate profile, and any job applications, resumes, or other information you choose to submit is subject to Jobot's Privacy Policy, as well as the Jobot California Worker Privacy Notice and Jobot Notice Regarding Automated Employment Decision Tools which are available at jobot.com/legal. Our team partners closely across engineering and production to optimize processes, implement advanced automation, and drive high-quality output across our operations.
NewProcess Engineer OP MobilityProcess EngineerElkhart, INToday, OPmobility develops technological solutions across four areas of expertise: exterior and lighting systems, the integration of complex modules, technologies related to energy storage, hydrogen and electrification, and a division dedicated to the development of embedded software and digital solutions. Bachelor's degree in Industrial Engineering, Manufacturing Engineering, Mechanical Engineering, Mechatronics, Industrial Automation, Electrical Engineering, or a related technical discipline preferred; equivalent experience may be considered.
NewSoftware Development Engineer JobotSoftware Development EngineerCarmel, IN$65–$80 / hourDevelopers at this level are building greater independence, taking ownership of small to medium-sized work items, and strengthening their core engineering skills across multiple application layers, including user interfaces, services, APIs, and data. Our teams include professionals across software engineering, product development, clinical informatics, research, and healthcare technology who share a commitment to reducing complexity and improving outcomes for patients and providers.
Data Engineer IV BC ForwardData Engineer IVIndianapolis, INRemoteFull timeThe ideal candidate will have strong experience in building scalable data pipelines, data architectures, and self-service analytics with AI enablement and a proven ability to deliver actionable insights, automate workflows, and improve customer experience outcomes . With delivery centers and offices across North America and India, we take pride in building long-term relationships and delivering excellence through innovation, collaboration, and integrity.
Senior Healthcare Data Engineer JobotSenior Healthcare Data EngineerIndianapolis, IN$120,000–$150,000 / yearYou'll partner closely with software engineers, product leaders, and external integration partners to solve challenging data quality problems while helping build a scalable framework for future healthcare integrations. Information collected and processed as part of your Jobot candidate profile, and any job applications, resumes, or other information you choose to submit is subject to Jobot's Privacy Policy, as well as the Jobot California Worker Privacy Notice and Jobot Notice Regarding Automated Employment Decision Tools which are available at jobot.com/legal.
Lead Network Engineer InfovisionLead Network EngineerEvansville, INFull timeIn addition to F5 expertise, the consultant must possess extensive NGINX Plus experience, including NGINX as a Service (NGINXaaS) in Azure, Azure Load Balancers, high-availability NGINX deployments, custom server farms, and production application delivery environments. The ideal Leand Engineer will be capable of independently leading provisioning, upgrades, integration, automation, troubleshooting, and operational optimization efforts across F5, NGINX Plus, Azure, and network infrastructure platforms.
Lead Network Engineer Above and Beyond Talent AcquisitionLead Network EngineerEvansville, IN$60–$65 / hourContractorFull timeFor over 100 years, their dedicated team has helped customers improve their financial lives with responsible, transparent solutions for debt, medical bills, home improvements, and auto purchases. Client Info / Who they are: Above and Beyond Talent Acquisition represents the country’s largest lending-exclusive financial company, serving millions with safe, affordable installment loans through 1,500 branches in 44 states.
Sr. Equipment Validation Engineer StratAcuity Staffing Partners IncSr. Equipment Validation EngineerLebanon, IN$40–$55 / hourIn terms of professional development, Apex hosts an on-demand training program, provides access to certification prep and a library of technical and leadership courses/books/seminars once you have 6+ months of tenure, and certification discounts and other perks to associations that include CompTIA and IIBA. Apex also offers a HSA (Health Savings Account on the HDHP plan), a SupportLinc Employee Assistance Program (EAP) with up to 8 free counseling sessions, a corporate discount savings program and other discounts.
NewValidation Engineer II Barry-Wehmiller Companies IncValidation Engineer IICarmel, INBy blending people-centric leadership with disciplined operational strategies and purpose-driven growth, Barry-Wehmiller has become a $3 billion organization with nearly 12,000 team members united by a common belief: to use the power of business to build a better world. Rooted in our distinct culture of Truly Human Leadership, we cultivate the leaders who will define tomorrow and partner with our clients in the food & beverage, life sciences, industrial, and advanced technology industries to build the future of manufacturing and technology.
Software Design Engineer in Test 3 Bucher & Christian Consulting, Inc. dba BCforward (BCF)Software Design Engineer in Test 3Indianapolis, INFull timeThe ideal candidate will have strong experience in designing and implementing automated test suites, CI/CD integration, and defect analysis and a proven ability to improve test coverage, ensure software quality, and support release readiness for prototype devices and builds. With delivery centers and offices across North America and India, we take pride in building long-term relationships and delivering excellence through innovation, collaboration, and integrity.
6321 - Validation Engineer / CQV Engineer - Change Control & Deviations Verista6321 - Validation Engineer / CQV Engineer - Change Control & DeviationsIndianapolis, IndianaThis role will play a critical part in maintaining compliance, supporting quality systems, and ensuring manufacturing changes are properly assessed, documented, and executed in a regulated cGMP environment. The nature of our business is to empower growth and innovation within the scientific community and to help researchers, organizations, and companies solve some of the world’s most pressing healthcare challenges.
NewSenior Validation Engineer Bristol-Myers Squibb CoSenior Validation EngineerIndianapolis, IN$107,904–$130,754 / yearBased on eligibility*, additional time off for employees may include unlimited paid sick time, up to 2 paid volunteer days per year, summer hours flexibility, leaves of absence for medical, personal, parental, caregiver, bereavement, and military needs and an annual Global Shutdown between Christmas and New Years Day. The Senior Validation Engineer will be responsible for the drafting and executing commissioning, qualification, and validation (CQV) documents and protocols which support the use of highly specialized facility, utility, analytical, and process equipment.
Validation Engineer 1 Bristol-Myers Squibb CoValidation Engineer 1Indianapolis, IN$82,236–$99,650 / yearBased on eligibility*, additional time off for employees may include unlimited paid sick time, up to 2 paid volunteer days per year, summer hours flexibility, leaves of absence for medical, personal, parental, caregiver, bereavement, and military needs and an annual Global Shutdown between Christmas and New Years Day. Working under the guidance of senior team members, the Validation Engineer I contributes to validation activities that support the transition from construction to clinical development and ongoing GMP commercial operations.
New6459 - Senior CQV Engineer / Senior Validation Engineer Verista6459 - Senior CQV Engineer / Senior Validation EngineerIndianapolis, IndianaConducting and documenting impact and risk assessments with a full understanding of equipment/system/software operation and ability to assess direct, indirect, and no impact systems and functions within complex processes. The nature of our business is to empower growth and innovation within the scientific community and to help researchers, organizations, and companies solve some of the world’s most pressing healthcare challenges.
CQV Engineer - Commissioning, Qualification & Validation PACIVCQV Engineer - Commissioning, Qualification & ValidationIndianapolis, INFull timeResponsibilities Develop and drive completion of Commissioning & Qualification (C&Q) deliverables, including validation plans, risk assessments, project strategies, user requirements, functional specifications, design specifications, impact assessments, traceability matrices, test cases, engineering studies, and final summary reports. CQV Engineer, Commissioning Engineer, Qualification Engineer, Validation Engineer, C&Q Engineer, Commissioning & Qualification Engineer, Pharmaceutical Validation Engineer, GMP Validation Engineer, Capital Projects Validation Engineer.
NewLead Validation Engineer Bristol-Myers Squibb CoLead Validation EngineerIndianapolis, IN$124,449–$150,803 / yearThe position applies broad engineering and GMP knowledge to support the transition from construction to clinical development and commercial operations, while also providing leadership in process improvement, deviation investigation, CAPA management, new technology implementation, and future expansion initiatives. Based on eligibility*, additional time off for employees may include unlimited paid sick time, up to 2 paid volunteer days per year, summer hours flexibility, leaves of absence for medical, personal, parental, caregiver, bereavement, and military needs and an annual Global Shutdown between Christmas and New Years Day.
Process Validation Engineer Katalyst Healthcares & Life SciencesProcess Validation EngineerIndianapolis, INThe ideal candidate will have experience with process validation, equipment qualification, CSV, temperature mapping, and regulatory compliance. We are seeking a Process Validation Engineer to support validation and qualification activities in a GMP-regulated manufacturing environment.
Process Validation Engineer Karwell TechnologiesProcess Validation EngineerIndianapolis, INThe ideal candidate will have experience with process validation, equipment qualification, CSV, temperature mapping, and regulatory compliance. We are seeking a Process Validation Engineer to support validation and qualification activities in a GMP-regulated manufacturing environment.
Validation Engineer - Project Farma PerkinElmer US LLCValidation Engineer - Project FarmaIndianapolis, IN$68,000–$80,000 / yearProject Farma (PF) team members collaborate with cross-functional teams to build trusted client relationships, deliver an exceptional customer experience, and contribute to business growth by identifying opportunities and applying data-driven insights to support project planning, cost, schedule, and performance management. Experience Required: Bachelor's Degree in Life Science, Engineering, or related discipline (OR a combination of equivalent work experience in capital project engineering, pharma cGMP facility start-up, CapEx/OpEx project management and/or comparable military experience.
Validation - Engineer III/Lead - Project Farma PerkinElmer US LLCValidation - Engineer III/Lead - Project FarmaIndianapolis, INContinually develop technical aptitude of Project Farma's core services within the life science space including but not limited to: Capital Project Management, Tech Transfers, Validation Life Cycles including CQV and Computer system Validation, Quality, Regulatory and Compliance, GxP Automated Systems, and Quality Control including clinical and commercial. Project Farma (PF) team members collaborate with cross-functional teams to build trusted client relationships, deliver an exceptional customer experience, and contribute to business growth by identifying opportunities and applying data-driven insights to support project planning, cost, schedule, and performance management.
Validation - Engineer III/Lead - Project Farma PerkinElmerValidation - Engineer III/Lead - Project FarmaIndianaContinually develop technical aptitude of Project Farma’s core services within the life science space including but not limited to: Capital Project Management, Tech Transfers, Validation Life Cycles including CQV and Computer system Validation, Quality, Regulatory and Compliance, GxP Automated Systems, and Quality Control including clinical and commercial. Project Farma (PF) team members collaborate with cross-functional teams to build trusted client relationships, deliver an exceptional customer experience, and contribute to business growth by identifying opportunities and applying data-driven insights to support project planning, cost, schedule, and performance management.
NewEquipment Validation Engineer Diverse Lynx, LLCEquipment Validation EngineerINDevelop detailed action plans to prepare affected OT systems for migration to new IT platforms and infrastructure. Execute migration readiness and transition plans in collaboration with site OT and IT Subject Matter Experts.
Senior Validation Engineer INCOG BioPharma Services IncSenior Validation EngineerFishers, INIf you crave the challenge of creating systems from scratch and believe you have insights for a better way of doing business, which benefits customers by ensuring quality outcomes and accelerating their route to market, we want to hear from you. Our culture and priorities are different by design: focused on building long-term value for our customers, we are committed to a service-culture mindset, technical excellence, and a collaborative and team-centered approach to doing business.
Validation Engineer - Project Farma PerkinElmerValidation Engineer - Project FarmaIndianaProject Farma (PF) team members collaborate with cross-functional teams to build trusted client relationships, deliver an exceptional customer experience, and contribute to business growth by identifying opportunities and applying data-driven insights to support project planning, cost, schedule, and performance management. With over an 80+ year legacy of advancing science and a mission of innovating for a healthier world, our dedicated team collaborates closely with commercial, government, academic and healthcare customers to deliver our broad portfolio of analytical solutions, and OneSource services.
Validation - Engineer I/II - Project Farma PerkinElmerValidation - Engineer I/II - Project FarmaIndianaProject Farma (PF) team members collaborate with cross-functional teams to build trusted client relationships, deliver an exceptional customer experience, and contribute to business growth by identifying opportunities and applying data-driven insights to support project planning, cost, schedule, and performance management. With over an 80+ year legacy of advancing science and a mission of innovating for a healthier world, our dedicated team collaborates closely with commercial, government, academic and healthcare customers to deliver our broad portfolio of analytical solutions, and OneSource services.
Validation Engineer (Contract) GenoviceValidation Engineer (Contract)Indianapolis, IndianaOur client, an innovative and fast-growing pharmaceutical manufacturing company, is seeking an experienced Equipment Validation Engineer to support validation efforts across its cGMP manufacturing and laboratory operations. Local candidates are preferred , but hybrid arrangements may be considered for candidates willing to travel on-site to Indianapolis 2–3 days per week.
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.
Validation Engineer Katalyst Healthcares & Life SciencesValidation EngineerLafayette, INThe consultants will support validation execution and gap assessments tied to equipment qualification, tank qualification, mixing studies, smoke studies, aseptic technique, and instrument/equipment qualification. This includes understanding tank qualification, viscosity considerations, matrix/bracketing approaches, risk assessment, and how to identify, group, and mitigate validation gaps.
Validation Engineer Karwell TechnologiesValidation EngineerLafayette, INThe consultants will support validation execution and gap assessments tied to equipment qualification, tank qualification, mixing studies, smoke studies, aseptic technique, and instrument/equipment qualification. This includes understanding tank qualification, viscosity considerations, matrix/bracketing approaches, risk assessment, and how to identify, group, and mitigate validation gaps.
Senior Validation Engineer Katalyst Healthcares & Life SciencesSenior Validation EngineerEvansville, INExperience working with bioprocess equipment including bioreactors, filtration systems, chromatography systems, and ultrafiltration (UF) preferred. Collaborate cross-functionally with Engineering, Quality Assurance (QA), Manufacturing, and Operations teams to support project execution and validation deliverables.
Senior Validation Engineer Karwell TechnologiesSenior Validation EngineerEvansville, INExperience working with bioprocess equipment including bioreactors, filtration systems, chromatography systems, and ultrafiltration (UF) preferred. Collaborate cross-functionally with Engineering, Quality Assurance (QA), Manufacturing, and Operations teams to support project execution and validation deliverables.
NewCQV Validation Engineer: Change Control & Deviation Lead VeristaCQV Validation Engineer: Change Control & Deviation LeadIndianapolis, INVerista, Inc. is looking for a CQV Engineer in Indianapolis, IN, to support change control and deviation management in a regulated cGMP environment. Candidates should possess a Bachelor's degree and have over 3 years of experience in CQV or Quality Engineering.
New6454 - Deviation Investigator / Validation Engineer Verista6454 - Deviation Investigator / Validation EngineerIndianapolis, IndianaThe nature of our business is to empower growth and innovation within the scientific community and to help researchers, organizations, and companies solve some of the world’s most pressing healthcare challenges. The actual salary is dependent upon a variety of job-related factors such as professional background, training, work experience, location, business needs, market demand, and competitive market practice.
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.
Validation Engineer Actalent IncValidation EngineerNoblesville, IN$48.08–$55.29 / hourThis role combines hands-on work on the manufacturing floor with extensive documentation, protocol development, and collaboration across Quality, Manufacturing, and Engineering teams to support innovative, life-saving medical devices. We are proud to be an Engineering News-Record (ENR) Top 500 Design Firm for our engineering design services and a ClearlyRated Best of Staffing winner for both client and talent service.
Sr. Validation & Compliance Engineer Katalyst Healthcares & Life SciencesSr. Validation & Compliance EngineerIndianapolis, INThe role involves developing and executing IQ/OQ/PQ protocols, supporting process validation and technology transfer activities, ensuring compliance with FDA/EMA regulations, and collaborating cross-functionally to deliver compliant and inspection-ready systems. Validation & Compliance Engineer to support commissioning, qualification, and validation (CQV) activities for equipment, utilities, and facilities within a regulated pharmaceutical/biotech manufacturing environment.
Validation - Lead Engineer - Project Farma PerkinElmer US LLCValidation - Lead Engineer - Project FarmaIndianapolis, INContinually develop technical aptitude of Project Farma's core services within the life science space including but not limited to: Capital Project Management, Tech Transfers, Validation Life Cycles including CQV and Computer system Validation, Quality, Regulatory and Compliance, GxP Automated Systems, and Quality Control including clinical and commercial. Project Farma (PF) team members collaborate with cross-functional teams to build trusted client relationships, deliver an exceptional customer experience, and contribute to business growth by identifying opportunities and applying data-driven insights to support project planning, cost, schedule, and performance management.
Test and Validation Software Engineer Matrix Design GroupTest and Validation Software EngineerNewburgh, INWork may involve exposure to electrical hazards and the use of hand tools, power supplies, and test fixtures; adherence to ESD controls and lockout/tagout or other required safety practices may be necessary. Work closely with software and hardware engineers, product managers, and other team members to ensure effective communication and understanding of project requirements.
Validation - Lead Engineer - Project Farma PerkinElmerValidation - Lead Engineer - Project FarmaIndianaContinually develop technical aptitude of Project Farma’s core services within the life science space including but not limited to: Capital Project Management, Tech Transfers, Validation Life Cycles including CQV and Computer system Validation, Quality, Regulatory and Compliance, GxP Automated Systems, and Quality Control including clinical and commercial. Project Farma (PF) team members collaborate with cross-functional teams to build trusted client relationships, deliver an exceptional customer experience, and contribute to business growth by identifying opportunities and applying data-driven insights to support project planning, cost, schedule, and performance management.
Validation - Engineer I/II - Project Farma PerkinElmer US LLCValidation - Engineer I/II - Project FarmaIndianapolis, IN$65,000–$80,000 / yearProject Farma (PF) team members collaborate with cross-functional teams to build trusted client relationships, deliver an exceptional customer experience, and contribute to business growth by identifying opportunities and applying data-driven insights to support project planning, cost, schedule, and performance management. Bachelor's Degree in Life Science, Engineering, or related discipline (OR a combination of equivalent work experience in capital project engineering, pharma cGMP facility start-up, CapEx/OpEx project management and/or comparable military experience.
Senior Engineer, Process Validation Danaher CorpSenior Engineer, Process ValidationIndianapolis, INRemote$100,000–$130,000 / yearLead the planning, execution, and lifecycle management of sterile fill-finish process validation strategies and qualification programs for aseptic manufacturing processes including sterile filtration, aseptic process simulation, sterile filling, visual inspection, container closure integrity testing, filter validation, labelling, packaging and shipping. In this role, you will have the opportunity to: Design, execute, and summarize deliverables across the three stages of process validation supporting process characterization and qualification spanning critical starting materials, drug substance, and drug product, product classifications aligned with FDA guidance, EU GMP Annex 15, and lifecycle approach.
Validation Engineering Roles Barry-Wehmiller Companies IncValidation Engineering RolesIndianapolis, INTechnical Skills & Qualifications: • Bachelor's degree in Engineering (Bioengineering, Biomedical, Chemical, Electrical, Mechanical, or equivalent technical degree) • Validation experience in automation, packaging, general drug substance and/or drug product systems/equipment, computer systems, utilities, and/or facilities • Strong technical writing and oral communication skills • Proficiency with project documentation and computer skills (Microsoft Office, Microsoft Project, AutoCAD) • Experience with entire project lifecycle from concept development through startup (preferred). Project Management & Leadership: • Lead all aspects of client relationship development and project execution • Develop project plans, strategies, and manage project resources, budgets, and schedules • Oversee complete project lifecycle from concept through design, implementation, installation, commissioning, and startup • Manage multiple project responsibilities simultaneously with excellent organizational skills • Focus on project success related to scope, schedule, budget, and client satisfaction.
Product Systems Validation Technical Specialists #IN1283 Cummins Inc.Product Systems Validation Technical Specialists #IN1283Columbus, IN$121,181–$128,400 / yearStart Date of Posting** : **6/25/26** **End Date of Posting: 7/10/26** **Location: Columbus** **Position: ON-SITE** ***Annual USD Salary Minimum – Maximum** **$121,181 - 128,400** **Job** Engineering **Organization** Cummins Inc. **Role Category** On-site with Flexibility **Job Type** Exempt - Experienced **Min Salary** $ **Max Salary** $ **ReqID** 2431449 **Relocation Package** Yes **100% On-Site** Yes Due to the operational nature and specific job duties of this role, work is required to be completed 100% in person/On-site. Utilize knowledge of product failure mode avoidance to mitigate potential failures by identifying interfaces, functions, functional requirements, interactions, control factors, noise factors, and prioritized potential failure modes and potential failure cases for the system of interest to effectively and efficiently improve the reliability of products.
Senior CSV Validation Specialist EXOS (formerly Sondhi Solutions)Senior CSV Validation SpecialistIndianapolis, INProven ability to author and execute validation deliverables, including Validation Plans, User Requirement Specifications, Functional Specifications, Design Specifications, Installation Qualification, Operational Qualification, Performance Qualification, Requirements Traceability Matrices, and Validation Summary Reports. The role supports the Site Automation Engineering organization and works closely with automation engineers, IT, system integrators, and site leadership to ensure systems are validated and maintained in a compliant state.
Validation Intern (Year-Round) BorgWarner IncValidation Intern (Year-Round)Kokomo, IN$17–$23 / hourAssist with validation laboratory setup and execution, including connecting devices under test (DUTs) to test equipment &/or coolant lines, moving equipment racks, and supporting test configurations. Perform basic operational and administrative support tasks to assist Validation Operations Engineers including workflow documentation, application administration, asset tracking, and a variety of ad hoc requests.
Senior Test and Validation Technician Matrix Design GroupSenior Test and Validation TechnicianNewburgh, INWork may involve exposure to electrical hazards and the use of hand tools, power supplies, and test fixtures; adherence to ESD controls and lockout/tagout or other required safety practices may be necessary. Associates degree in Engineering, or related technical field or equivalent experience in testing, installation and configuration of products and operation of heavy equipment and machine shop.
NewPackaging Engineering Lead - Validation, Compliance & Innovation HarbaPackaging Engineering Lead - Validation, Compliance & InnovationIndianapolis, INYou will own validation activities (IQ/OQ/PQ), drive tech transfers, support FDA/regulatory inspections, and partner with Manufacturing, QA, Regulatory, and Supply Chain to ensure compliant, efficient packaging operations.#J-18808-Ljbffr. Harba in Indianapolis is seeking a Packaging Engineer to lead design, qualification, and troubleshooting of pharmaceutical packaging lines, including blister, cartoning, labeling, serialization, and filling/capping processes.
Quality Assurance – Computer System Validation (CSV) ElancoQuality Assurance – Computer System Validation (CSV)Clinton, INFull timeRequired Experience: Minimum 5–7 years of experience in a GxP regulated environment (Pharmaceutical, Biotech, or Medical Device), including at least 3–5 years of experience in Computer System Validation (CSV) or Computer System Quality Assurance (CSQA). Top 2 Skills: Strong knowledge of Data Integrity and computerized system validation regulations (21 CFR Part 11, Annex 11, ALCOA++), and ability to influence and coach cross-functional technical teams on compliance requirements.
Associate Validation Technician Carrier CorporationAssociate Validation TechnicianFort Wayne, IN$31,500–$56,500 / yearThrough cutting-edge advancements in climate solutions such as temperature control, air quality and transportation, we improve lives, empower critical industries and ensure safe transport of food, lifesaving medicines and more. Time off and Leave: Paid vacation days, up to 15 days; paid sick days, up to 5 days; paid personal leave, up to 5 days; paid holidays, up to 13 days; birth and adoption leave; parental leave; family and medical leave; bereavement leave; jury duty leave; military leave; purchased vacation.
Senior QA Validation Specialist INCOG BioPharma Services IncSenior QA Validation SpecialistFishers, INThe Senior Quality Validation Specialist provides Quality Assurance oversight of validation activities across the site, with a focus on new equipment commissioning and qualification, equipment change controls, and equipment life cycle documentation. This role is responsible for ensuring that User Requirements Specifications (URS), risk assessments, qualification protocols, and cleaning validation activities are compliant with applicable regulatory expectations, industry guidance documents, and internal procedures.