Validation Engineer

Katalyst HealthCares and Life Sciences

• $90K — $120K *
Rahway, NJ 07065In-Person
Pharmaceuticals & Biotech
8 - 10 years of experience
More than 3 months ago
Job Overview by Ladders

Qualifications

  • Minimum of 8 years in a GXP/Analytical lab setting.
  • Experience with complex GMP instruments like HPLC, GC, and UV VIS.
  • Proven ability to lead a support team and provide training.
  • Skilled in managing multiple facilities and resource planning.
  • Experience in reviewing GMP documentation collaboratively.
  • Proven track record in process improvement and efficiency driving.
  • Strong decision-making skills for prioritizing tasks effectively.

Responsibilities

  • Administer lab systems and support requests via the ticketing system.
  • Work with lab analysts to identify and confirm issues.
  • Resolve requests and problems following established procedures.
  • Coordinate with equipment owners and Quality Assurance for system changes.
  • Document change processes thoroughly and accurately.
  • Manage completion of requests and updates in the ticketing system.
  • Track and coordinate periodic reviews of lab systems.

Benefits

  • Collaborative working environment with strong team dynamics.
  • Opportunities for technical training and professional development.
  • Support for innovation and efficiency improvements.
  • Exposure to various GXP and GMP processes across multiple sites.
  • Engagement with Quality Assurance and stakeholders for holistic lab management.
Full Job Description
Summary:
  • 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, GC, 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:
  • Provide lab system administration and support via the ticketing system (e.g., help requests, user access requests).
  • Collaborate with lab analysts and end users to confirm problems or requests.
  • Resolve issues or fulfill requests (onsite or remotely) by following SOPs and procedural guidelines.
  • Coordinate system changes with equipment owners and Quality Assurance representatives.
  • Complete change-related documentation.
  • Close requests in the ticketing system.
Requirements - Periodic Lab System Review:
  • Track due dates for lab system reviews using a scheduler.
  • Coordinate reviews with equipment owners.
  • Follow system SOPs for reviews and deliverables.
  • Complete tasks required for each review.
  • Generate required documents/artifacts and deliverables.
  • Finalize documentation with appropriate review and approval.
* Ladders Estimates

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