- Lead and manage multiple commissioning / qualification / validation activities performed at facility with minimal supervision.
- Equipment Qualification / Re-Qualification (IQ, OQ, PQ) for process equipment, QC equipment, packaging equipment, clean utilities.
- Cleaning Verification / Validation studies for transferred products.
- Media Fills / process simulations protocols.
- Engineering protocols to support packaging validation / shipping study activities.
- Trackwise deviations and qualification / validation deviations related to equipment / instrument, cleaning, and process non-conformances.
- ssist in execution of Process Validation and Engineering studies.
- Review commissioning, qualification, validation projects performed by Validation Specialists and / or Validation contractors.
- Generate Validation Master Plans (VMPs) and Risk Assessments related to large level qualification projects.
- Monitor and track protocol and report status.
- Complete GMP Impact Assessments, System Component Criticality Reviews, Traceability Matrixes, Design Qualification, Vendor documentation checklists, and final handover of documents to Operations with minimal supervision.
- Mentor and train junior level Validation Specialists on various validation tasks.
- Plan and complete commissioning, qualification, and validation activities performed in facility.
- Complete Trackwise deviations and qualification / validation deviations related to equipment / instrument, cleaning, and process non-conformances, and assist Validation Specialist with same activities.
- Resolve observation / CAPAs generated from internal and external cGMP audits related to Validation, Qualification, and Commissioning studies.
- Participate and able to answer questions during intern and external audits, as needed.
- Close change controls, CAPAs, and investigations, as well as ensure deviations, CAPAs, and change controls issued to the department(s) are tracked (closed on time, or extended if necessary.)
- Prepares Final Reports summarizing the results of executed Validation / Qualification studies and address comments and questions from reviewers / approvers.
- ssist Production, Engineering, and/ or IT in improving / optimizing performance of process / packaging equipment.
- Update yearly Validation Master Plan.
- Bachelor's degree in engineering or related field, or equivalent combination of education and work-related experience, required.
- Minimum 5 years of hands-on experience in validation (PV, CV), specifically within the pharmaceutical sector.
- Subject matter expert in at least two (2) of the Qualification / Validation subjects specified below
- Sterile Process Equipment Qualification
- Packaging Equipment Qualification
- Media Fills
- Utilities Commissioning / Qualification
- Cleaning Verification / Validation
- Process Validation
- QC Equipment Qualification
- Computer System Validation
- Environmental Monitoring Qualification of Classified Areas
- Understanding of validation principles, current Good Manufacturing Practices (cGMP), and applicable regulatory requirements
- Proficiency in equipment and process validation, including Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ).
- Excellent problem-solving and analytical skills.
- Strong communication and teamwork abilities.
- bility to work independently in a timely manner.
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Validation Engineer
10 hours ago
Insight Global Parsippany, United StatesDay to Day: · Insight Global is seeking an experienced Sr. Validation Specialist to join one of our large pharmaceutical clients for a full time position. This position will be 5 days a week onsite, in Parsippany, NJ. This individual will play a crucial role in ensuring quality ...
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Validation Engineer
2 weeks ago
Insight Global Parsippany-Troy Hills, United States5+ years Validation specialist or engineer within Pharma or Biopharma · Experience executing and writing test protocols Qualification (IQ), Operational Qualification (OQ), Performance Qualification (PQ) · Comprehensive knowledge of production processes · Knowledge of Capa and De ...
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Product Validation Engineering Technician
2 days ago
Cummins New York, United States**Product Validation Engineering Technician · - 1st Shift** · **Pay Range $30.46- $45.69** · Our culture believes in _POWERING YOUR POTENTIAL_. We provide global opportunities to develop your career, make your community a better place and work with today's most innovative thinker ...
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Validation Engineer
1 week ago
LanceSoft Summit, United StatesTitle: Engineering - Validation Engineer · Location: Summit NJ 07901 · Duration: 6 months(High Possibility of extension for right candidate) · Comments:100% onsite · Highly preferred cell therapy equipment commissioning qualification. · Must Have: Develops validation/qualificat ...
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Validation Engineer
1 week ago
TSR Consulting Summit, United StatesAbout TSR: · TSR is a relationship-based, customer-focused IT and technical services staffing company. · For over 40 years TSR, Inc. and its wholly owned subsidiary, TSR Consulting Services, have prospered in the Information Technology staffing business, earning the respect of co ...
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Validation Engineer
1 week ago
Yoh Summit, United StatesYoh is seeking a Validation Engineer for our well established pharmaceutical company. The Validation Engineer supports the successful implementation of various process/lab equipment at multi-use sites through interaction with internal customers and external service providers. The ...
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Validation Engineer
3 days ago
System One Holdings, LLC Summit, United StatesJob Title: Validation Engineer · Location: Summit, NJ · Type: Contract · Responsibilities Maintains qualified equipment systems in compliance with policies, guidelines and procedures: Develops qualification protocols, and associated reports while adhering to a change managemen ...
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Validation Engineer
6 days ago
Yoh, A Day & Zimmermann Company Summit, United StatesJob Description · Job Description Yoh is seeking a Validation Engineer for our well established pharmaceutical company. The Validation Engineer supports the successful implementation of various process/lab equipment at multi-use sites through interaction with internal customers ...
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Validation Engineer
6 days ago
Cynet Systems Summit, United StatesJob Description: · Pay Range: $79hr - $81hr · Responsibilities: The Equipment Validation Engineer supports the successful implementation of various process/lab equipment at multi-use sites through interaction with internal customers and external service providers. · The incumben ...
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Validation Engineer
1 week ago
Axelon Summit, United StatesJob Description: 100% Onsite position · PURPOSE AND SCOPE OF POSITION: · The Equipment Validation Engineer supports the successful implementation of various process/lab · equipment at multi-use sites through interaction with internal customers and external service · providers. Th ...
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Validation Engineer
1 week ago
Mindlance Summit, United StatesJob Description: 100% Onsite position · PURPOSE AND SCOPE OF POSITION: · The Equipment Validation Engineer supports the successful implementation of various process/lab · equipment at multi-use sites through interaction with internal customers and external service · providers. Th ...
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Validation Engineer
3 days ago
TSR Consulting Summit, United StatesAbout TSR: · TSR is a relationship-based, customer-focused IT and technical services staffing company. · For over 40 years TSR, Inc. and its wholly owned subsidiary, TSR Consulting Services, have prospered in the Information Technology staffing business, earning the respect of co ...
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Validation Engineer
5 days ago
TSR Consulting Summit, United StatesAbout TSR: · TSR is a relationship-based, customer-focused IT and technical services staffing company. · For over 40 years TSR, Inc. and its wholly owned subsidiary, TSR Consulting Services, have prospered in the Information Technology staffing business, earning the respect of ...
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Validation Engineer
1 week ago
Aequor Inc Summit, United StatesPosition: Validation Engineer · Location: Summit NJ 07901 · Duration: 6+ months (possibility of extension for the right candidate depending on performance) · Pay rate: $78.66/ hour on W2 · 100% onsite · Highly preferred cell therapy equipment commissioning qualification. · ...
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Validation Engineer
23 hours ago
Yoh, A Day & Zimmermann Company Summit, United StatesJob Description · Job Description Yoh is seeking a · Validation Engineer · for our well established pharmaceutical company. The Validation Engineer supports the successful implementation of various process/lab equipment at multi-use sites through interaction with internal cust ...
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Validation Engineer
2 days ago
Yoh Summit, NJ, United StatesYoh is seeking a Validation Engineer for our well established pharmaceutical company. The Validation Engineer supports the successful implementation of various process/lab equipment at multi-use sites through interaction with internal customers and external service providers. T ...
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Validation Engineer
2 days ago
Yoh Summit, NJ, United StatesYoh is seeking a Validation Engineer for our well established pharmaceutical company. The Validation Engineer supports the successful implementation of various process/lab equipment at multi-use sites through interaction with internal customers and external service providers. The ...
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Validation Engineer
1 week ago
eTeam New York, United StatesJob Title: Validation Engineer · Location: Athens, GA · Duration: 06 months · Duties: · Perform Smoke studies and assist in semi-annual Media fill qualifications as a SME Perform requalification/periodic review of autoclaves, depyrogenation tunnels, cold rooms, freezers and ware ...
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Validation Engineer
10 hours ago
Acara Solutions, An Aleron Company New Jersey, United StatesAcara Solutions is seeking a Validation Engineer for its successful client who are a leading world supplier of integrated processing solutions for customers in the area of pharmaceuticals, food processing, feeds and fine chemicals. Our products and services stand for reliability ...
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Validation Engineer
1 week ago
Kashiv BioSciences LLC Piscataway, United StatesKey Duties & Responsibilities · Draft and implement Quality System documentation including SOPs and Traceability Matrix designed to establish good validation practices within the organization. · Author URS, IQ, OQ and PQ protocols and execute them in compliance with GDP guideline ...