Validation Engineer

Piper Companies; Clayton (NC); On-site; USD 114,000 - 128,000; Full time

Benefits offered by this job

Sick leave if required by law

Medical, dental, vision insurance

401K

Job summary

A globally recognized biologics company is seeking a Validation Engineer for an on-site position in Clayton, NC. The role involves executing validation protocols, preparing documentation, and ensuring compliance in aseptic pharmaceutical manufacturing. Candidates should have 2–5 years of validation experience and knowledge of GMP. A competitive salary range of $114,000‑128,000/year and comprehensive benefits are included.

Qualifications

• 2–5 years of hands‑on validation experience in aseptic pharmaceutical manufacturing.
• Experience with filling isolator equipment highly preferred.
• Must be able to work on‑site five days a week.

Responsibilities

• Execute validation protocols on aseptic fill finish lines.
• Draft, review, and execute IQ/OQ/PQ protocols.
• Prepare and maintain validation documentation in TIMS.

Skills

Validation in aseptic pharmaceutical manufacturing

GMP understanding

Proficiency in TIMS

Job description

Piper Companies is seeking a Validation Engineer for a globally recognized biologics company. This Validation Engineer will be supporting validation protocol execution in a cutting‑edge aseptic pharmaceutical manufacturing environment. This is a fully on‑site position in Clayton, NC.

Responsibilities of the Validation Engineer

• Execute validation protocols on aseptic fill finish lines.
• Draft, review, and execute IQ/OQ/PQ protocols for aseptic filling isolators and Optima filling lines.
• Perform qualification of filling isolator systems, including environmental monitoring and smoke studies.
• Prepare and maintain validation documentation in TIMS.

Qualifications for the Validation Engineer

• 2–5 years of hands‑on validation experience in aseptic pharmaceutical manufacturing environments, with a strong understanding of GMP and regulatory compliance.
• Experience with filling isolator equipment is highly preferred; familiarity with Optima filling lines is a significant advantage.
• Proficiency in TIMS (Tracking and Information Management System) or similar validation documentation platforms (e.g., Kneat) is desirable.
• Must be able to work on‑site at our facility five days a week.

Compensation for the Validation Engineer

• Salary Range: $114,000‑128,000/year
• Comprehensive Benefits: Sick leave if required by law, medical, dental, vision, 401K

Keywords: Validation, aseptic fill lines, fill finish, validation protocols, optima, optima fill lines, IQ/OQ/PQ, filling isolator system, smoke studies, biologics, manufacturing, TIMS, execute, isolator, aseptic, documentation, GMP, protocols, validation engineer, CQV engineer, filling line qualification engineer, process validation, CQV, manufacturing systems validation specialist.

#LI-CL1

This job opens for applications on 11/07/2025. Applications for this job will be accepted for at least 30 days from the posting date.