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 of experience in a GXP/Analytical lab environment.
  • Proficient in medium to complex GMP instruments (e.g., HPLC, FTIR, NMR).
  • Experience managing a support team, providing technical assistance and training.
  • Ability to manage operations across multiple sites with strong planning skills.
  • Familiar with reviewing GMP deliverables in collaborative environments.
  • Adept at identifying process improvements and enhancing efficiency.
  • Strong decision-making capabilities to handle competing priorities.

Responsibilities

  • Provide lab system administration and support through a ticketing system.
  • Collaborate with lab analysts to confirm and address user requests or issues.
  • Resolve technical issues and fulfill access requests using SOPs.
  • Coordinate system changes with relevant stakeholders, including Quality Assurance teams.
  • Document change processes and close requests in the ticketing system.
  • Manage and track due dates for system reviews using a scheduler.
  • Generate and review documentation related to system operations and approvals.

Benefits

  • Opportunities for professional growth and development.
  • Collaborative work environment with cross-functional teams.
  • Potential for remote work flexibility.
  • Engagement in process improvement initiatives.
Full Job Description
Roles & Responsibilities:
  • 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.
  • 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.
  • Education & Experience:
  • 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.
* Ladders Estimates

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