Piper Companies
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.
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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.
#J-18808-Ljbffr