Validation Engineer

Piper Companies is seeking a Validation Engineer – Aseptic Fill-Finish Facility to join a leading pharmaceutical manufacturing organization for a 6 month onsite contract with extensions based out of Clayton, NC. The Validation Engineer – Aseptic Fill-Finish Facility will play a key role in supporting commissioning, qualification, and validation efforts tied to a sterile production environment while ensuring systems meet regulatory and operational standards.

Responsibilities of the Validation Engineer include:

· Prepare and carry out commissioning and qualification deliverables including IQ, OQ, and PQ protocols and final reports

· Partner with cross-functional teams such as Quality, Engineering, Automation, and Manufacturing to coordinate validation execution activities

· Lead risk assessments, system impact evaluations, and apply risk-based validation methodologies

· Investigate and resolve deviations, non-conformances, and implement CAPA actions tied to qualification efforts

· Support startup activities including process validation, sterilization cycles, media fills, and facility readiness initiatives

Qualifications for the Validation Engineer include:

· Bachelor’s degree in Engineering, Life Sciences, or another relevant technical field

· Minimum of 3 years of experience performing CQV or validation work within pharma, biotech, or sterile manufacturing settings

· Hands-on exposure to qualifying GMP systems such as sterilization equipment, inspection systems, or aseptic processing equipment

· Experience developing and executing IQ/OQ/PQ documentation along with strong technical writing capabilities

· Solid understanding of FDA GMP regulations, EU Annex 1, and industry validation practices

Compensation for the Validation Engineer:

Salary Range: $155,000-$175,000/year (USD)

Comprehensive Benefits: Medical, Dental, Vision, sick leave if required by law, and 401K

This job opens for applications on 7/2/2026. Applications for this job will be accepted for at least 30 days from the posting date.

Keywords: validation engineer, CQV, commissioning, qualification, aseptic manufacturing, sterile fill finish, GMP, IQ OQ PQ, FDA regulations, Annex 1, biotech, pharmaceutical manufacturing, deviation management, CAPA, risk assessment, process validation, automation systems, technical writing, compliance, equipment qualification

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