Validation Engineer GMP Lab Systems & Instrument Support at Rahway, NJ

Validation Engineer GMP Lab Systems & Instrument Support
Location : Rahway , NJ
Requirements:
A minimum of 8 years work experience in GXP / Analytical lab environment.
Experience handling medium to complex GMP instruments such as UV VIS, FTIR, NMR, Polarimeter, XRD, HPLC, , etc.
Ability to manage a support team onsite/offshore, assign tasks, and provide technical assistance and training.
Skilled in managing multiple sites with strong planning and demand management.
Experience in reviewing GMP deliverables in a team setting.
Ability to identify process improvement areas and drive efficiency.
Strong decision-making skills to handle competing priorities effectively.
Experience in internal stakeholder management, collaboration, and periodic metrics reporting.
Responsibilities Lab System Support:
1.Provide lab system administration and support via the ticketing system (e.g., help requests, user access requests).
2.Collaborate with lab analysts and end users to confirm problems or requests.
3.Resolve issues or fulfill requests (onsite or remotely) by following SOPs and procedural guidelines.
4.Coordinate system changes with equipment owners and Quality Assurance representatives.
5.Complete change-related documentation.
6.Close requests in the ticketing system.
Responsibilities Periodic Lab System Review:
1.Track due dates for lab system reviews using a scheduler.
2.Coordinate reviews with equipment owners.
3.Follow system SOPs for reviews and deliverables.
4.Complete tasks required for each review.
5.Generate required documents/artifacts and deliverables.
6.Finalize documentation with appropriate review and approval.