CQV Engineer

Piper Companies is seeking a Validation Engineer to join a growing leader in the pharmaceutical/biotechnology space for an onsite contract position in Clayton, North Carolina (NC). The Validation Engineer will be responsible for executing validation protocols for aseptic fill-finish pharmaceutical manufacturing equipment and processes, ensuring compliance with regulatory standards through onsite support and documentation.

Responsibilities of the Validation Engineer include:

• Execute validation protocols for aseptic pharmaceutical manufacturing processes, with a focus on fill-finish operations.
• Support equipment validation activities, particularly for filling isolators and automated filling lines.
• Document validation activities using electronic systems such as TIMS or similar platforms.
• Collaborate cross-functionally with engineering, quality, and production teams to ensure compliance and timely execution.
• Maintain a consistent onsite presence (5 days/week) to support active validation efforts and troubleshooting.

Qualifications for the Validation Engineer include:

• 2–5 years of hands-on validation experience in aseptic pharmaceutical manufacturing environments.
• Experience with filling isolator equipment; familiarity with Optima filling lines is highly desirable.
• Proficiency with validation documentation systems (e.g., TIMS, Kneat, or equivalents).
• Strong understanding of GMP regulations and validation lifecycle principles.

Compensation for the Validation Engineer:

• Salary Range: $62,000-$72,000/year (USD)
• Comprehensive Benefits: Medical, Dental, Vision, sick leave if required by law, and 401K

This job opens for applications on 11/7/25. Applications for this job will be accepted for at least 30 days from the posting date.

Keywords: validation engineer, aseptic manufacturing, pharmaceutical validation, fill finish, isolator equipment, Optima filling lines, GMP, TIMS, Kneat, equipment qualification, protocol execution, process validation, cleanroom, FDA compliance, commissioning and qualification, validation lifecycle, onsite engineer, pharma operations, sterile manufacturing, validation documentation

#LI-JN1

#LI-ONSITE