Pharma Validation Engineer — GMP & CPV Expert

Serovia; Branchburg Township (NJ); On-site; USD 90,000 - 120,000; Full time

Job summary

Serovia in New Jersey is seeking a Validation Engineer to execute and maintain site validation activities across equipment, processes, and systems, ensuring cGMP compliance and a qualified state throughout the product lifecycle.

You will collaborate with Manufacturing, Engineering, QA, and Regulatory Affairs to execute PPQ/PQ/CPV, develop validation documents, and support regulatory inspections; strong writing and risk-analysis skills are required.

Qualifications

• Bachelor’s degree in Engineering, Life Sciences, Pharmacy, or related field.
• 3–5 years pharma/biotech validation experience (5 preferred).
• Solid knowledge of FDA cGMPs, ICH Q8–Q10, EU Annex 15.
• Experience with sterile injectable manufacturing and aseptic processes.
• Hands-on with data logger and steam sterilization qualifications.
• Strong technical writing and documentation review skills.
• Ability to manage multiple projects in a fast-paced environment.
• Commitment to data integrity, patient safety, and product quality.

Responsibilities

• Execute validation and qualification activities per procedures and regulatory requirements.
• Maintain site Validation Master Plan (VMP) and ensure timelines.
• Develop and maintain validation lifecycle documents and reports.
• Support PPQ, PQ, CPV to ensure process consistency and control.
• Collaborate with Engineering, Manufacturing, QA to assess changes needing qualification.
• Prepare and review validation protocols, ensuring traceability and justified results.
• Participate in risk assessments (FMEA) to identify and mitigate risks.
• Support audits by providing validation evidence and regulatory compliance.

Skills

cGMP compliance

Process validation

Qualification & validation

Documentation & writing

Cross-functional collaboration

Data integrity

Regulatory inspections readiness

Education

Bachelor’s degree in Engineering/Life Sciences/Pharmacy

Tools

GxP document systems

Job description

Serovia in New Jersey is seeking a Validation Engineer to execute and maintain site validation activities across equipment, processes, and systems, ensuring cGMP compliance and a qualified state throughout the product lifecycle.

You will collaborate with Manufacturing, Engineering, QA, and Regulatory Affairs to execute PPQ/PQ/CPV, develop validation documents, and support regulatory inspections; strong writing and risk-analysis skills are required.