CQV Downstream Engineer
Listed on 2026-10-16
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Engineering
Validation Engineer, Pharma Engineer, Regulatory Compliance Specialist, Quality Engineering
Stark Pharma Solutions Inc. is a global consulting and staffing partner established in 2014, serving the Pharmaceutical, Medical Device, Biotech, and IT industries across the USA, Canada, and India. We provide specialized consulting and staffing solutions across Quality & Validation, Regulatory Affairs, R&D, Manufacturing, Supply Chain, Project Management, and IT, with a focus on delivering tailored solutions that drive growth, operational excellence, and long-term client success.
AboutThe Company
Stark Pharma Solutions Inc. is a global consulting and staffing partner established in 2014, serving the Pharmaceutical, Medical Device, Biotech, and IT industries across the USA, Canada, and India. We provide specialized consulting and staffing solutions across Quality & Validation, Regulatory Affairs, R&D, Manufacturing, Supply Chain, Project Management, and IT, with a focus on delivering tailored solutions that drive growth, operational excellence, and long-term client success.
Position:CQV Downstream Engineer
Location:
North Carolina Pay Rate:
Long Term Job Overview
We are seeking a CQV Downstream Engineer with 3 5+ years of experience in commissioning, qualification, and validation within pharmaceutical or biotech manufacturing environments. The role will support downstream equipment and systems, CQV documentation, equipment qualification, and vendor activities.
Key Responsibilities- Review engineering design documents, drawings, datasheets, specifications, and equipment lists.
- Support preparation and execution of CQV documentation for downstream systems.
- Support FAT, DQ, RTM, QRA, SAT, IOC, and IOQ activities.
- Prepare and support qualification and validation reports.
- Support development of downstream bridging documents.
- Coordinate with Process Science teams on process requirements, CPDs, and CQAs.
- Review vendor documentation and equipment packages.
- Support CQV activities for downstream manufacturing systems.
- Troubleshoot and resolve equipment and qualification-related issues.
- Ensure activities comply with GMP and project requirements.
- Bachelor s degree in Engineering, Life Sciences, or a related field.
- 3 5+ years of experience in CQV, validation, commissioning, or related roles.
- Pharmaceutical or biotech manufacturing experience.
- Experience with downstream processing equipment such as filtration, chromatography, buffer/media systems, and process support equipment.
- Knowledge of GMP requirements and pharmaceutical validation practices.
- Familiarity with FDA, EMA, and GAMP guidelines.
- Experience with CQV documentation and qualification activities.
- Strong technical documentation, troubleshooting, and problem-solving skills.
- Good communication and teamwork skills.
Stark Pharma is an Equal Opportunity Employer and welcomes qualified candidates from diverse backgrounds.
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