Validation Engineer

4 weeks ago

Thousand Oaks, California, United States PSC Biotech Full time
Job Summary

PSC Biotech is seeking an experienced Validation Engineer to support commissioning and qualification activities of equipment, systems, facilities, and utilities. The ideal candidate will have a strong background in commissioning, qualification, and validation in the pharmaceutical industry.

Key Responsibilities
  • Generate and execute CQPs, IQs, OQs, PQs, test plans, timelines, reports, and identify any potential associated issues or discrepancies for a variety of equipment and systems.
  • Perform activities such as Cycle Development (CD), Design Qualification, Commissioning & Qualification, Performance Qualification (PQ), Cleaning Validation (CV), and Validation Maintenance.
  • Support capital projects and departmental validation activities.
  • Manage or support all qualification execution and documentation reporting for fill lines, freezers, water systems, HVAC, CIP/SIP stations for tanks and filter units, vial washers, tunnel sterilizers, and other related/required facilities equipment and systems.
  • Generate and own all required documentation including but not limited to system assessments, URS, specifications, drawings, change control tasks, and so on.
  • Support test case execution and corrective actions.
  • Work collaboratively with cross-functional teams to drive project success and completion.
  • Effectively communicate action items, risks, etc. to stakeholders.
Requirements
  • Bachelor's degree in a related engineering discipline.
  • 3 years or more of commissioning, qualification, and validation experience in the pharmaceutical industry.
  • Strong knowledge of industry regulations and standards.
  • Excellent technical writing skills.
  • Detail-oriented and strong commitment to quality.
  • Excellent communication and interpersonal skills.
  • Strong organization and time management skills.
Benefits

PSC Biotech offers a full suite of benefits, including medical, dental, and vision insurance, 401(k) and 401(k) matching, PTO, sick time, and paid holidays, education assistance, pet insurance, discounted fitness rates, and financial perks and discounts.

The salary for this role is set between $95,000 and $115,000 annually, and may be adjusted based on various factors such as the applicant's qualifications, skills, and professional experience.

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