Process Validation Engineer
Katalyst HealthCares & Life Sciences
Job-ID32212336Reference26-00532 Responsibilities: Lead migration of legacy documents into Kneat digital platform, ensuring compliance and consistency. Qualify redundant lab equipment (e.g., pH meters, thermal mixers, peristaltic pumps, nutating mixers) to ensure operational integrity. Perform equipment and temperature mapping studies, particularly for Ellab systems, based on project needs. Support Process Engineers by filling resource gaps, ensuring projects remain on track during critical milestones. Document and support Computer Systems Validation (CSV) tasks as needed to meet regulatory requirements. Requirements: Bachelor's degree in Engineering, Science, or related field. Experience with equipment qualification, validation, or regulatory compliance. Familiarity with Kneat digital platform or similar document management systems. Strong understanding of CSV (Computer Systems Validation) principles. Knowledge of temperature mapping methodologies. Familiarity with Ellab systems or similar validation equipment. Lean/ Six Sigma certifications or continuous improvement experience is a plus. Excellent attention to detail and strong documentation skills. Ability to work independently and collaboratively in a fast-paced environment.
- DescriptionTSMS - Senior Process Validation EngineerThe Senior Process Validation Engineer - Technical Services and Manufacturing Sciences (TSMS) will be responsible for leading all facets of Process Validation, GMP Floor Support, and Continued Process Verification in accordance...SuggestedFull timeH1bWork at officeVisa sponsorshipWork visa
- ...particularly for Ellab systems, based on project needs. Support Process Engineers by filling resource gaps, ensuring projects remain on track... ...critical milestones. Document and support Computer Systems Validation (CSV) tasks as needed to meet regulatory requirements....Suggested
- ...ensuring sterile injectable manufacturing processes are robust, reproducible, and compliant?... ..., and we're looking for a process validation professional with hands-on experience and... ...cycle.The Senior QA Process Validation Engineer, II provides QA oversight of Process Design...SuggestedFull timeH1bVisa sponsorshipWork visa
- ...here to meet the exacting needs of our clients. We provide process development, produce GMP viral vectors, and provide cell transduction... ...can be part of that team. JOB SUMMARY The Sr. Process/Validation Engineer plays a key role supporting operations at Genezen's gene...SuggestedFor contractorsWork experience placementLive inLocal areaVisa sponsorship
- ...Job Description Position Overview \n We are seeking an experienced Quality Validation Engineer to support process validation efforts within a regulated pharmaceutical manufacturing environment. This individual will provide Quality Assurance oversight throughout...SuggestedContract work
- ...302816Reference26-00646 Job Summary:We are seeking a Sr. Validation & Compliance Engineer to support commissioning, qualification, and validation (... ...developing and executing IQ/OQ/PQ protocols, supporting process validation and technology transfer activities, ensuring compliance...
- ...Quality Assurance & Commissioning/Qualification Engineer (Medical Device & Pharmaceutical Manufacturing)... ...play a critical role in ensuring manufacturing processes, equipment, and systems are designed, qualified, and validated to meet quality and regulatory requirements....Contract work
- ...Performance Validation is seeking a Senior Validation Engineer/Specialist (Level III) to join our Indianapolis team. You will provide leadership across validation, engineering, and compliance, and mentor less experienced staff while delivering client-focused guidance....
$111.2k - $166.8k
...manufacturing quality — and in this role, you will own it. As a Sr. Validation Engineer, you will lead and execute validation activities across a... ..., coordinate, and execute validation protocols covering process, equipment, facility, utilities, computerized systems, and...Shift workWeekend work- DescriptionINCOG BioPharma is seeking a highly motivated Senior Validation Engineer with validation expertise to join our team. The Senior... ...and re-qualification of equipmentAssess risks involved in processing steps related to equipment, developing and/or reviewing validation...Full timeH1bVisa sponsorshipWork visa
- ...Group is a fully integrated architecture, engineering, construction, system integration, and... ...build a better world.Job Description:Validation Engineer III Who You’ll Work With You will... ...assist in the design of manufacturing processes, help manage projects, develop...Full timeWork at officeFlexible hours
- ...partners as required to support commissioning, qualification, and validation activities for GMP and supporting spaces, including office,... ..., utility, analytical, laboratory, sterility assurance, and process systems. Support environmental monitoring programs, aseptic...For contractorsWork at officeImmediate start
$107.9k - $130.75k
...importantly, on patients. Learn more about RayzeBio: The Senior Validation Engineer, CQV Sterility Assurance supports the radiopharmaceutical... ..., utility, analytical, laboratory, sterility assurance, and process systems. This role supports validation lifecycle activities...Hourly payFull timeFor contractorsWork experience placementSummer workLive inWork at officeLocal areaImmediate startFlexible hours$87.15k - $94.6k
...through our rigorous approach, field-tested processes, and elite expertise developed over 30... ...Commissioning, Qualification, and Validation (CQV) activities with a strong focus on... ...Experience- Bachelor's degree (BS/BA) in Engineering, Chemistry, or Life Sciences (relevant...For contractorsWorldwide- ...professionals to lead CQV activities across GMP spaces and analytical systems. You will develop and execute validation strategies, environmental monitoring and sterile process validation, and support investigations and CAPA across development and manufacturing operations....
$72.8k - $80.1k
...highest standard—through our rigorous approach, field-tested processes, and elite expertise developed over 30 years.Our PurposeWe exist... ...and Experience- Bachelor's degree in a science or engineering field (or equivalent experience)- 2–4 years' experience in commissioning...Worldwide- ...Validation / CQV Engineer (Commissioning, Qualification & Validation) Indianapolis, IN | Up to 40% Travel Find out more about the daily... ...Operations Clean Utilities & Facility Systems Process Automation & Controls Systems What You Will Do...Full timeH1bImmediate start
- ...is an excellent opportunity to gain hands-on experience in the engineering field while working on impactful projects. The ideal candidate... ...updates on project status and contributing ideas for process improvements. Conduct research and analysis to support ongoing...Temporary workWork at officeRelocation
- ...Overview The Process Engineer supports plastics manufacturing operations in a medical device manufacturing environment by optimizing manufacturing... ...equipment and process lifecycle activities, including validation, qualification, installation, commissioning, startup, and...Full time
- ...Job Title: Process Engineer / AVI Consultant Location: Holly Springs, NC (Onsite) Company: United Pharma Technologies Inc Employment Type: Contract Industry: Pharma/Bioteh Job Description: We are seeking an experienced Process Engineer / AVI Consultant...Contract workLocal area
- ...package. Come grow with us! This role is 100% onsite, at the manufacturing plant in Indianapolis, IN. Scope: The Senior Process Engineer (Aseptic) provides technical support for manufacturing and process systems that drive improvement in overall equipment...Full time
- ...the Operations Manager, you will serve as the primary owner of process development for priority businesses and brands, leading major... ...that enable optimized system design. You will leverage process engineering expertise, external and internal resources, and a results-...Full timeLocal areaFlexible hours
- ...lives of people all over the world and fuel the progress of humankind.Corteva Agriscience has an opportunity for a Downstream Process Engineer. You will lead the development and scale-up of downstream processes that convert fermentation-derived materials into high-quality...Local area1 day per week
- ...regulatory compliance and requires strong technical writing and collaboration with cross-functional teams. Requirements include an engineering/STEM degree, 1–3 years of experience, proficiency with Microsoft Office, and the ability to work onsite in Indianapolis. #J-188...Work at office
$69.3k - $102.62k
...linked to verified root causes. Requirements ~ Undergraduate Engineering/STEM degree preferred (mechanical, chemical, biomedical, etc.)... ...Paid Parental Leave and Bereavement Verista collects and processes personal data in accordance with applicable data protection...Temporary workWork experience placementInternshipWork at office- ...together to advance human health for tomorrow.Learn about the Danaher Business System which makes everything possible.The Senior Process Engineer is responsible for supporting process engineering activities for the Indianapolis Site for Life Science Products. This person...Full timePart time
- ...Quality Assurance & Commissioning/Qualification Engineer (Medical Device & Pharmaceutical Manufacturing)... ...play a critical role in ensuring manufacturing processes, equipment, and systems are designed, qualified, and validated to meet quality and regulatory requirements....Contract work
$110k - $140k
...LHH is seeking a Process Engineer for a Direct Hire, Permanent Placement position with a precision machining client located in Indianapolis, IN. This is an exciting opportunity to join a growing organization that specializes in highly engineered, custom-built products...Permanent employmentLocal area$28.85 - $40.86 per hour
...Job Title: Process Engineer Job Description The Process Engineer leads the design and implementation of manufacturing process solutions for production facilities. This role focuses on raw material storage, processing, thermal processing, mixing and blending,...Contract workTemporary workFor subcontractorCasual workWork at office$250k
...Your Role: Provide technical engineering oversight for all phases of commercial... ...a Subject Matter Expert (SME) to lead process investigations, identify root causes for... ...SOPs, P&IDs, electrical drawings, and validation protocols to ensure regulatory compliance...For contractorsWork experience placement
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