Equipment Validation Engineer
2 - 5 years
New Jersey, United States
Full-time
Onsite
1 month ago
About the role
Position Summary
We are seeking a detail-oriented Equipment Validation Engineer with 0–3 years of experience to support equipment qualification and validation activities within a cGMP-regulated pharmaceutical/biotech manufacturing environment in New Jersey . This role offers hands-on exposure to IQ/OQ/PQ execution, commissioning & qualification (C&Q), and regulatory compliance (FDA, cGMP) , making it an excellent opportunity for early-career professionals to build a strong foundation in validation and quality systems.
Key Responsibilities
Basic Qualifications
Preferred Qualifications
We are seeking a detail-oriented Equipment Validation Engineer with 0–3 years of experience to support equipment qualification and validation activities within a cGMP-regulated pharmaceutical/biotech manufacturing environment in New Jersey . This role offers hands-on exposure to IQ/OQ/PQ execution, commissioning & qualification (C&Q), and regulatory compliance (FDA, cGMP) , making it an excellent opportunity for early-career professionals to build a strong foundation in validation and quality systems.
Key Responsibilities
- Execute and support Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ) protocols for manufacturing equipment.
- Assist in authoring, reviewing, and executing validation protocols, reports, and technical documentation .
- Participate in commissioning and qualification (C&Q) activities for new equipment and system modifications.
- Perform test execution, data analysis, and documentation in compliance with cGMP and GDP standards.
- Collaborate cross-functionally with Engineering, Manufacturing, and Quality Assurance (QA) teams.
- Support deviation investigations, change controls, and CAPA activities related to validation.
- Assist in risk assessments (FMEA, impact analysis) to support validation planning.
- Ensure compliance with data integrity standards (ALCOA+) .
- Support calibration, preventive maintenance, and equipment lifecycle documentation .
- Maintain validation documentation in an audit-ready state for regulatory inspections.
Basic Qualifications
- Bachelor’s degree in Mechanical, Chemical, Biomedical, or related Engineering discipline .
- 0–3 years of experience in validation, engineering, or quality within regulated environments (internships/projects acceptable).
- Working knowledge of cGMP, FDA regulations, and validation lifecycle concepts .
- Familiarity with IQ/OQ/PQ documentation and execution .
- Strong technical writing and documentation skills.
- Effective communication and collaboration skills.
Preferred Qualifications
- Exposure to pharmaceutical, biotechnology, or medical device manufacturing .
- Basic understanding of critical utilities (HVAC, compressed air, WFI/PW systems) .
- Experience or familiarity with TrackWise, SAP, Veeva, or similar quality systems .
Skills
Consulting