HB
Validation Engineer / CQV
Hired by Matrix
🇺🇸 United States
On-site
3 months ago
$63 – $65 / hour
- GMP
- GxP
- Technical Writing
- Airflow
- HVAC
- CAPA
3 months ago
Are you ready to build your career by joining a certified technology solutions and compliance consulting services company? If so, our client is hiring a Validation Engineer / CQV.
Position Type:
- Contract
- On-Site
- Bachelor's degree in Engineering, Life Sciences, Biotechnology, or related discipline.
- 3 - 10 years of experience in CQV, Validation, or Pharmaceutical Manufacturing environments.
- Hands-on experience with equipment qualification (IQ/OQ/PQ) in regulated GMP facilities.
- Experience qualifying manufacturing equipment, autoclaves, washers, filling systems, and laboratory equipment.
- Knowledge of temperature mapping and qualification methodologies.
- Understanding of GxP regulations and validation lifecycle principles.
- Experience reviewing and approving validation documentation and SOPs.
- Strong technical writing and execution skills.
- Experience in both sterile and non-sterile pharmaceutical manufacturing environments.
- Familiarity with Validation Master Plans (VMPs).
- Process Validation experience.
- Cleaning Validation experience.
- Previous consulting or project-based validation experience preferred.
- Support commissioning, qualification, and validation activities for a new GMP facility and manufacturing areas.
- Author, review, and execute validation deliverables including MVPs, Validation Plans, IQ/OQ/PQ protocols, traceability matrices, and validation summary reports.
- Perform cleanroom qualification activities including airflow visualization, room recovery testing, differential pressure verification, and environmental monitoring support.
- Execute qualification activities for autoclaves, parts washers, glassware washers, CTUs, process equipment, and associated utility systems.
- Perform temperature mapping studies for refrigerators, freezers, incubators, stability chambers, warehouses, and other controlled temperature storage areas.
- Support qualification of facility and utility systems including HVAC, WFI, clean steam, compressed gases, and other GMP utilities.
- Investigate protocol deviations, discrepancies, and validation issues; support impact assessments, root cause investigations, and CAPA activities.
- Review, revise, and author SOPs, work instructions, and other controlled GMP documentation to support startup and operational readiness.
- Work closely with Engineering, Facilities, Quality, Manufacturing, and vendors to support project timelines and qualification activities.
- Support change controls, commissioning turnover packages, punch list resolution, and validation lifecycle activities as required.
- Ensure all qualification and validation activities are performed in accordance with GMP requirements, site procedures, and project schedules.
Key Responsibilities:
- Review, execute, and provide technical sign-off on qualification documentation, including SOPs and validation protocols.
- Support commissioning, qualification, and validation (CQV) activities for manufacturing and utility equipment.
- Perform and document Performance Qualifications (PQs) for GMP manufacturing systems.
- Execute qualification activities for:
- Benchtop laboratory equipment
- Autoclaves
- Washers
- Filling equipment
- General manufacturing equipment
- Temperature mapping studies
- Support Validation Master Plan (VMP) execution and compliance activities.
- Ensure all qualification and validation activities comply with GxP requirements and company procedures.
- Collaborate with Quality, Manufacturing, Engineering, and Validation teams to meet project timelines.
- Provide support for sterile and non-sterile manufacturing operations.
- Contribute to process validation and cleaning validation activities as required.
We want to hear from you! If you think you'd be a good match, submit your resume and reach out to Priyanshu at 201-478-6913 to learn more.
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Validation Engineer / CQV · Hired by Matrix