Bachelor's degree in Engineering, Life Sciences, or related field preferred; equivalent hands-on validation experience considered
Direct validation engineering or CQV experience in a GMP environment
Strong exposure to fill/finish operations and aseptic manufacturing equipment
Familiarity with GMP documentation and protocol execution
Ability to document in real time and manage discrepancies
Experience with sterile manufacturing and equipment qualification
Responsibilities
Support hands-on execution of OQ/PQ protocols
Document GMP activities in real time
Identify discrepancies and deviations during qualification processes
Assist in equipment qualification activities
Drive qualification deliverables to completion
Collaborate on protocol execution and closeout
Benefits
Opportunity to work onsite in a dynamic and fast-paced project environment
Engagement in challenging validation work that impacts sterile manufacturing
Potential for exposure to advanced fill/finish technologies
Hands-on role where independent work is encouraged
Collaboration with seasoned professionals in the field
Full Job Description
Job Description:
Client is looking for onsite Validation Engineers / CQV Engineers to support upcoming qualification work tied to sterile manufacturing and fill/finish operations. The consultants will support hands-on OQ/PQ execution, GMP documentation, protocol execution, discrepancy/deviation support, and equipment qualification activities.
The ideal candidate will have direct validation engineering or CQV experience in a fast-paced GMP environment, with strong exposure to fill line qualification, aseptic filling, sterile manufacturing equipment, and execution-heavy validation work. Equipment experience with autoclaves, formulation equipment, fill suites, high-velocity fillers, isolators, parts washers, tanks, and aseptic process systems is highly relevant.
Experience with vision systems or automated inspection systems is a strong plus, especially for candidates who have worked around high-speed fill lines or aseptic manufacturing lines. Candidates should be able to work independently onsite, execute protocols accurately, document in real time, identify discrepancies, and help drive qualification deliverables through completion.
Requirements:
Bachelor's degree in Engineering, Life Sciences, or a related technical discipline preferred. Equivalent hands-on validation/CQV experience in GMP manufacturing environments can be considered.
Strong Plus Skills:
septic Fill/Finish Equipment Experience: Exposure to isolators, high-velocity fillers, formulation equipment, fill suites, parts washers, tanks, and autoclaves.
Sterilization / Sterile Manufacturing Systems: Experience with SIP, VHP, autoclaves, and sterile equipment qualification.
Vision / Inspection System Experience: Background with vision systems or automated inspection systems, especially tied to aseptic filling or high-speed manufacturing lines.
Validation Tools / Execution Support: Experience using Kaye validators, wireless probes, and supporting hands-on protocol execution.
Documentation & Closeout: Strong ability to document execution in real time, manage discrepancies, and support protocol package closeout.
Include Must Have:
Hands-on validation engineering or CQV experience.
Strong OQ/PQ execution and documentation background.
Fill/finish, aseptic filling, or fill line qualification experience.
Sterilization or sterile manufacturing equipment experience.
GMP documentation experience.
Protocol execution experience.
Deviation/discrepancy support experience.
bility to work independently in a fast-paced project environment.
Experience supporting equipment qualification in a regulated life sciences environment.
