Validation Engineer

Stark Pharma; Concord (NC); On-site; USD 80,000 - 100,000; Full time

Job summary

Stark Pharma is seeking a Validation Engineer in Concord, NC. This role will focus on execution of validation activities in a GMP-regulated pharmaceutical environment. Responsibilities include developing validation protocols, ensuring compliance with regulatory requirements, and collaborating with cross-functional teams. Candidates should have 3-7+ years of validation experience and a strong background in GMP compliance. The position is long-term and onsite, requiring a bachelor's degree in a relevant field.

Qualifications

• 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.

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.

Skills

Equipment validation

Utility validation

Process validation

GMP compliance

Regulatory compliance

Risk assessments

Education

Bachelor's degree in Engineering, Science, or related field

Job description

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.

Job Title: Validation Engineer
Location: Concord, NC (Onsite)
Duration: Long Term

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

Required Qualifications

• 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