GMP Validation Engineer | IQ/OQ/PQ & Compliance
E-Solutions Inc.
E Solutions, LLC seeks a Validation Engineer in Indianapolis, IN to manage commissioning and qualification activities for new equipment. Candidates require a Bachelor's degree in a relevant field and at least five years of experience in a regulated environment. The role involves ensuring compliance with FDA standards, maintaining documentation, and collaborating with engineering and regulatory teams. Occasional travel to client sites is required. #J-18808-Ljbffr
- ..., Qualification, and Validation (CQV) activities with... ...Documentation & Compliance - Support the generation... ...commissioning, FATs, IQ, OQ, and PQ activities - Coordinate... ...’s degree (BS/BA) in Engineering, Chemistry, or Life... ...experience in a GMP (Good Manufacturing Practice...SuggestedFor contractorsWorldwide
- ...global provider of system validation and lifecycle services—... ...therapies. Job Title: GMP Equipment Validation Engineer – CQV Location:... ...seamless integration and compliance with regulatory standards... ...documentation including URS, DQ, IQ, OQ, and PQ protocols and reports....SuggestedImmediate start
- ...Bristol-Myers Squibb is seeking a Lead Validation Engineer in Indianapolis to support radiopharmaceutical facility operations. This role... ...validation activities and provides technical guidance on GMP compliance, ensuring quality in our mission to develop transformative...Suggested
$105.1k - $174.12k
...What Engineering Management contributes to Cardinal Health Engineering... ...Lead validation programs across facilities,... ...equipment, and systems Ensure compliance with cGMP, FDA, USP, and other... ...standards Oversee execution of IQ/OQ/PQ, process validation, cleaning...SuggestedTemporary workWork experience placementLocal areaImmediate startFlexible hours- ...Bristol-Myers Squibb is seeking a Lead Validation Engineer in Indianapolis to support the Radiopharmaceutical... ..., applying broad engineering and GMP knowledge. You will collaborate with... ...and drive continuous improvement in compliance and efficiency. Candidates should have...Suggested
- ...Lead the BMS validation lifecycle across... ...Qualification (IQ), Operational Qualification (OQ), and Performance... ...Qualification (PQ) protocols.... ...and audit trail compliance across Metasys and... ...the Integration Engineer on alarm management... ...pharmaceutical/GMP-regulated environment...
$59.95k - $102.62k
...expertise We are seeking a CQV Engineer to support change control... ...part in maintaining compliance, supporting quality systems,... ...medical device manufacturing. Validation Engineer / CQV Engineer Responsibilities... ...validation documentation (IQ/OQ/PQ, protocols, reports)...Temporary workWork experience placement- ...Validation Engineering Roles page is loaded## Validation Engineering Roleslocations: Indianapolis... ...matter experts within our Regulatory Compliance Practice to deliver the highest quality... ...equipment • Perform FAT, SAT, IQ, and OQ documentation development and execution...Contract workWork at officeImmediate start
- ...a Manufacturing Process Engineer with at least 3 years of... ...responsible for developing, validating, and improving... ...processes while ensuring compliance with FDA, ISO 13485, GMP, and other regulatory requirements... ...validation activities including IQ, OQ, PQ, and process capability...
- ...Do you enjoy being the go-to Quality Engineering partner for customers and cross-functional... ...by building inspection plans, shaping validation strategies, and transferring NPIs into... ...comfortable supporting audits and ensuring compliance to Avalign procedures, customer...
- ...Job Title: Manufacturing Engineer Job Duration: 12 Months Job Location: Indianapolis... ...reliability, energy efficiency, and regulatory compliance. Provide technical support during... ...engineering standards. Comments for Suppliers: GMP experience in Pharma Background....
$59.95k - $102.62k
...from our experiences to enhance our collective expertise Validation/CQV Engineer Responsibilities: Authoring, editing, and executing technical... ...and time management skills Strong attention to detail GMP and Good Documentation Practice training (may be completed...Temporary workWork experience placementWork at office$66k - $171.6k
...Description The position of Principle Process Engineer - API EM Small Molecule reports to the... ...sets to ensure success of process validations Direct and Indirect interaction with CM... ...equipment specification, procurement, and IQ/OQ/PQ Participation with internal and CM resources...Full timeContract workTemporary workWork experience placementH1bVisa sponsorshipWork visaRelocation packageFlexible hours- ...Automation Engineer We are committed to providing reasonable accommodations... ...have alignment with the validation strategies and quality... ...and equipment qualification (IQ,OQ,PQ), Test Methods are a plus.... ...requirements, FDA 21 CFR 820/GMP Medical Device Regulations....Contract workTemporary workLocal areaVisa sponsorship
$95k - $130k
...lines. Execute FAT, SAT, IQ/OQ/PQ protocols in compliance with cGMP, FDA, and EMA standards... ...SOPs, batch records, validation protocols, and change... ...Bioengineering, or related engineering/scientific field. 3-5+ years... ...Familiarity with FDA/EMA GMP, ISPE guidelines, ASTM standards...Full timeContract workShift work$93.8k - $174.2k
Novartis Farmacéutica in Indianapolis, Indiana, is seeking an experienced engineer to support capital initiatives and manufacturing technologies in a GMP-regulated environment. Candidates should have a Bachelor's degree in engineering and at least 5 years of experience...- VALIDATION ASSOCIATES LLC is seeking a Utility Engineer in Indianapolis, Indiana, to optimize and maintain utility systems... ...during project phases, ensuring compliance with cGMP and regulatory guidelines... ...in facilities engineering, GMP expertise, and AutoCAD skills. #J...
$107.9k - $130.75k
## Lead Validation EngineerIndianapolis - RayzeBio - INFind out how well... ...RayzeBio: Lead Validation Engineer will support the Radiopharmaceutical facility and GMP operations in Indianapolis and... ...milestones aligned with business and compliance objectives.* Provide technical...Hourly payFull timeTemporary workPart timeFor contractorsWork experience placementSummer workLive inWork at officeLocal areaImmediate startRemote workFlexible hours- ...innovate and grow by designing, engineering, and executing the... ...and technologies, ensuring compliance with GMP, GAMP 5, ISA-88, and ISA-95... ...manufacturing, quality, and validation to ensure automation solutions... ...and documentation supports IQ/OQ/PQ execution. • Embed data integrity...
- Initial Therapeutics, Inc. is seeking a Manager - Validation Lead in Indianapolis to drive computer system validation activities. You will... ...lead automation and innovation using AI tools while ensuring compliance and quality. Ideal candidates will have 8-10 years of...Flexible hours
- A leading pharmaceutical company in Indianapolis is seeking a Validation Lead to oversee the site's validation strategy, ensuring compliance with regulatory standards. The role involves developing validation plans and collaborating with various departments for successful...Relocation package
$94.16k - $153.01k
...Description Job Title: Manufacturing Engineer - External Supply Chain Working Pattern... ...evaluate Methods of Manufacture and compliance to Design Intent while ensuring consistency... ...level of performance is sustainable Validate the supplier's method of manufacture and...Permanent employmentWork at officeRemote workRelocation packageFlexible hours3 days per week- ...A leading engineering firm in Indianapolis is looking for Validation Engineers to support capital project CQV delivery in the Life Sciences industry. This role involves developing validation and compliance documents, managing client relationships, and leading project execution...
- ...small teams in document development and/or execution Qualifications and Experience - Bachelor’s degree in a science or engineering field (or equivalent experience) - 2–4 years’ experience in commissioning and qualification in a regulated industry -...Worldwide
- ...Description Job Description Valspec—a global provider of system validation and lifecycle services—provides commissioning and... ...the discovery of new and innovative therapies. VALIDATION ENGINEER Location: Indianapolis, IN (AUTOMATION, INFORMATION & OPERATIONS...Immediate start
- Overview The Manufacturing Engineer plans, directs, and coordinates manufacturing processes... ...Document cost savings. Write and execute validation protocols. Assure projects follow design... ...standards ISO13485/FDA practices, GMP, and similar regulated industry standards...H1bWork at office
- ...Rolls-Royce plc in Indianapolis seeks a Manufacturing Engineer – Automation and Digital. You will enhance manufacturing capabilities... ...engineering activities, developing automation projects and ensuring compliance with safety and quality standards. Ideal candidates possess a...Flexible hours
$105.1k - $174.12k
...Cardinal Health, Inc. is looking for a Validation Engineering Manager in Legendary Hills, Indiana. This role involves leading validation programs and ensuring compliance with FDA and other regulatory standards. Ideal candidates should have 8-12 years of experience, as...$66k - $171.6k
Initial Therapeutics, Inc. is seeking a Warehouse Process Engineer based in Indianapolis, Indiana. This role will focus on analyzing workflows in a GMP setting, identifying inefficiencies, and implementing data-driven improvements. The ideal candidate should have a Bachelor...- Rolls-Royce plc in Indianapolis is seeking a Manufacturing Engineer to lead and improve manufacturing processes while ensuring compliance with safety and quality standards. This role involves developing processes applicable to Statistical Process Control and driving a...
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