What are the responsibilities and job description for the Validation Engineer position at Stark Pharma?
Job Title: Validation Engineer
Location: Concord, NC (Onsite)
Duration: Long Term
Job Summary
We are seeking a Validation Engineer to support validation activities within a GMP-regulated pharmaceutical manufacturing environment. This role will focus on equipment, utilities, and process validation, ensuring compliance with regulatory requirements and supporting ongoing manufacturing operations.
The ideal candidate will have strong experience in IQ/OQ/PQ, documentation, and cross-functional collaboration within pharma or biotech settings.
Key Responsibilities
Location: Concord, NC (Onsite)
Duration: Long Term
Job Summary
We are seeking a Validation Engineer to support validation activities within a GMP-regulated pharmaceutical manufacturing environment. This role will focus on equipment, utilities, and process validation, ensuring compliance with regulatory requirements and supporting ongoing manufacturing operations.
The ideal candidate will have strong experience in IQ/OQ/PQ, documentation, and cross-functional collaboration within pharma or biotech settings.
Key Responsibilities
- Execute and support equipment, utility, and process validation activities (IQ, OQ, PQ)
- Develop and review validation protocols, reports, and supporting documentation
- Ensure compliance with GMP, FDA, and regulatory requirements
- Perform risk assessments and support validation strategies
- Collaborate with Engineering, Quality, and Manufacturing teams
- Support deviation investigations, CAPA, and change control activities
- Assist with commissioning and qualification (CQV) activities
- Maintain accurate and compliant documentation
- Bachelor s degree in Engineering, Science, or related field
- 3 7 years of experience in validation within pharmaceutical or biotech industry
- Hands-on experience with IQ/OQ/PQ and validation documentation
- Strong understanding of GMP and regulatory compliance
- Experience with equipment and/or utility validation