GMP CQV Engineer: Qualification & Validation Specialist
Intellectt Inc
Intellectt Inc is seeking a CQV Engineer to support and execute qualification activities in GMP-regulated pharmaceutical manufacturing in Indiana. The role includes preparing CQV documentation, conducting on-site commissioning and qualification testing, and ensuring compliance with regulatory requirements. The ideal candidate should have strong knowledge of GMP, GxP, and FDA regulations, hands-on experience in qualification activities, and the ability to review technical documents accurately. The position emphasizes attention to detail and coordination with cross-functional teams. #J-18808-Ljbffr Intellectt Inc
- ...expansion project. We are seeking a junior-to-mid level CQV / Commissioning Engineer to support execution activities for facility and... ...in accordance with site procedures and GMP expectations. Must-Have Qualifications ~2–3+ years of commissioning, CQV, or execution...Suggested
- The CQV Engineer will support commissioning, qualification, and validation activities within GMP-regulated pharmaceutical manufacturing facilities. The role is responsible for executing qualification activities, ensuring equipment, utilities, systems, and processes meet...SuggestedFor contractors
- Eli Lilly and Company is seeking a Warehouse Process Engineer at the Lilly Medicine Foundry in Lebanon, Indiana. This on-site role involves... ...a Bachelor’s degree in Industrial Engineering, experience in a GMP setting, and strong analytical skills. This position offers...Suggested
$66k - $171.6k
Initial Therapeutics, Inc. seeks an Engineer - Automation Engineering to work in the Automation Engineering Department at Eli Lilly, Foundry... ...support across operating areas and capital projects in a GMP regulated environment. The ideal candidate has at least two years...SuggestedFull time$100k - $130k
...of experience in automation engineering, building automation, HVAC controls... ..., biotech, life sciences, or GMP‑regulated manufacturing... ...engineering, facilities, IT/OT, QA, CQV, operations, maintenance,... ...8 Desired Candidate Profile Qualifications: BACHELOR OF COMPUTER SCIENCE...Suggested$123k - $180.4k
...Therapeutics, Inc. is seeking an Associate Director for Biologics Process Engineering to lead the team at the new Lilly Medicine Foundry in Lebanon,... ...support for biologics manufacturing, ensuring compliance with GMP standards, and fostering a collaborative work culture. The...$66k - $171.6k
...people around the world. The Engineer - Automation Engineering will... ...required to support GMP operations, and build the site... ...production data • Maintain the validated state of the site control systems... ..., commissioning and qualification of highly automated greenfield...Full timeWork experience placementH1bVisa sponsorshipWork visaFlexible hours- A global IT services company is seeking a Sr. Equipment Validation Engineer in Lebanon, Indiana. The role involves supporting compliance processes... ...3 years’ experience, with strong skills in Installation Qualification, Operational Qualification, and Performance Qualification....
$66k - $171.6k
...Therapeutics, Inc. is seeking a Process Control and Automation Engineer for their new manufacturing facility in Lebanon, Indiana.... ...Building Management and HVAC Control Automation solutions. Required qualifications include a Bachelor's degree in engineering, substantial...- Technical Source is currently in search of a Validation Engineer for a pharmaceutical manufacturing client in the Greater Indianapolis Area... ...should have experience conducting the Commissioning, Qualification, and Validation of HVAC and Utilities Systems in a Pharmaceutical...Long term contractVisa sponsorship
- Lilly is seeking a Process Engineer for their new advanced manufacturing facility in Lebanon, IN. The role includes providing critical engineering support for facility start-up and operations in ATMP manufacturing. The successful candidate will need a Bachelor’s Degree...
$66k - $171.6k
...environmental impact. The Engineer - Automation Engineering will... ...required to support GMP operations, and build the site... ...Specifications. Maintain the validated state of the site control... ...development, commissioning and qualification of highly automated greenfield...Permanent employmentFull timeH1bVisa sponsorshipWork visaFlexible hours$66k - $171.6k
Senior/Principal Process Engineer page is loaded## Senior/Principal Process Engineerlocations... ...to enable a successful startup into GMP manufacturing operations.We are seeking... ...reviews, alarm requirements, Performance Qualification requirements/protocol development, etc.)...Full timeH1bVisa sponsorshipWork visaFlexible hours$66k - $171.6k
...and execute the Automation Engineering Project Plan and uphold operational... ...integration. Maintain the validated state of control systems per... ...corporate expertise. Qualifications Minimum B.S. in Engineering... ...full‑time basis. Knowledge of GMP, regulatory requirements,...Permanent employmentFull timeFlexible hours$129k - $189.2k
...Lilly Medicine Foundry Process Engineering organization is responsible... ...successful transition to GMP manufacturing. Responsibilities... ...(e.g., DynoChem, Aspen) to validate reactor geometries, mixing... ...technical requirements. Basic Qualifications PhD in Chemical Engineering...Permanent employmentFull timeTemporary workFlexible hours$64.5k - $167.2k
Initial Therapeutics, Inc. in Lebanon, Indiana seeks a Senior Engineer in Automation Engineering. The role involves providing automation support for various sites and capital projects, focusing on Instrumentation and Control Hardware. Candidates must have a B.S. in Engineering...$66k - $171.6k
Eli Lilly and Company is seeking a Process Automation and Control Engineer for its new Peptides API facility in Lebanon, Indiana. You will be instrumental in implementing and optimizing the DeltaV process control system within specialized teams, ensuring safety and compliance...$66k - $171.6k
Organization and Position Overview The Engineer - Automation Engineering will... ...and instrumentation in a GMP regulated environment. Key... ...specifications. Maintain the validated state of site control systems... ..., commissioning, and qualification of highly automated greenfield...Permanent employmentFull timeVisa sponsorshipFlexible hours- Initial Therapeutics, Inc. is seeking a Senior Principal Engineer - Automation Engineering in Lebanon, Indiana. This role focuses on providing automation support, ensuring compliance, and mentoring junior engineers. The ideal candidate will have 8+ years in biopharma engineering...
$64.5k - $143k
...people around the world. The Engineer - Automation Engineering will... ...required to support GMP operations, and build the site... ...data • Maintain the validated state of the site control systems... ...development, commissioning and qualification of highly automated greenfield...Permanent employmentFull timeWork experience placementH1bVisa sponsorshipWork visaFlexible hours- Associate Director Process Engineering - Small Molecule API page is... ...enable a successful startup into GMP manufacturing operations.***... ...decisions, commissioning & qualification strategies etc.* Collaborate... ..., expert opinions, validations, annual product reviews, manufacturing...
$123k - $180.4k
...Director - Biologics Process Engineering, Lilly Medicine... ...processes required to support GMP operations, and build the site... ...submissions, expert opinions, validations, annual product reviews, manufacturing... ...flow documents, personnel qualification strategies, control...Permanent employmentFull timeFlexible hoursWeekend work$64.5k - $167.2k
...successful candidate will help to build the processes and facility to enable a successful startup into GMP manufacturing operations. Job Description: The Civil Engineer is responsible for overseeing the facilities at the Lebanon Plant 1 API Manufacturing site. This role...Contract workLocal area- Initial Therapeutics, Inc. is seeking a Senior Principal Engineer in Lebanon, Indiana, to lead automation engineering efforts at the Lilly Medicines Foundry. Responsibilities include providing automation support for manufacturing operations and capital projects, mentoring...
$66k - $171.6k
...Process Automation and Control Engineer - Peptides APIApplylocations:... ...required to support GMP operations, and build the site... ...automated system commissioning and qualifications.**Technology and Innovation:*... ...preferred* Experience working with validated systems* Experience with...Full timeH1bVisa sponsorshipWork visaMonday to FridayFlexible hours$66k - $171.6k
...enable a successful startup into GMP manufacturing operations.**... ...Control and Automation Engineer is responsible for the development... ..., verification, and qualification of process control and automation... ...models, along with supporting validation, qualification, and verification...Full timeH1bVisa sponsorshipWork visaFlexible hours$66k - $171.6k
...enable a successful startup into GMP manufacturing operations. Process Control and Automation Engineer (PCAE-BMS/HVAC) The Process... ..., verification, and qualification of Building Management and HVAC... ...models as well as supporting the validation and qualification or verifications...Full timeWork experience placementH1bVisa sponsorshipWork visaFlexible hours- ...quality always”. As an Engineer - MES your main function will... .... · Ensure project and/or validation documentation is maintained... ...regulatory requirements in GMP (Good Manufacturing Practice... ...Syncade) Experience Basic Qualifications: · Bachelor of Science...Full timeWork experience placementH1bLocal areaVisa sponsorshipWork visaMonday to FridayFlexible hours
$64.5k - $158.4k
...Be Doing: As an Informatics Engineer, you will partner with the Process... ...design, configuration, validation, and release - serving as an... ...Develop and implement Installation Qualification (IQ), Operational... ...requirements. Experience working in a GMP‑regulated environment (...Permanent employmentFull timeH1bRemote workVisa sponsorshipWork visaFlexible hours2 days per week$126k - $224.4k
About the Role As an MES Engineer at the Lilly Medicine Foundry,... ...workflows. Support IQ/OQ/PQ validation activities, author and review... ...in a pharmaceutical GMP environment, ideally including... ...manufacturing context. Basic Qualifications Bachelor’s degree in Software...Permanent employmentFull timeApprenticeshipFlexible hours
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