Senior Validation Specialist

3 weeks ago


Philadelphia Pennsylvania, United States WuXi AppTec Full time
Job Summary

We are seeking a highly skilled Senior Validation Specialist to join our team at WuXi AppTec. As a key member of our validation team, you will be responsible for ensuring the quality and integrity of our systems and processes.

Key Responsibilities
  • Develop and execute validation plans, protocols, and reports in accordance with 21 CFR Part 11 and GAMP5 guidelines.
  • Collaborate with cross-functional teams, including equipment owners, IT, and QA, to resolve complex quality issues.
  • Write, execute, review, or approve equipment and software validations, including IQ, OQ, and PQ.
  • Guide peers in the writing and execution of equipment and software validations.
  • Work with IT and system vendors to create test scripts and support new system introductions.
  • Participate in generating impact assessments, risk assessments, requirements traceability, URS, FDS, and validation project plans.
  • Stay current with changes to GXP regulations, including FDA and EU guidelines.
  • Interact with laboratory, manufacturing, and facility staff to provide expertise on equipment and software validations.
  • Address conditions and practices with appropriate personnel and report findings to validation management.
  • Participate in quality and process improvement initiatives and project teams.
  • Support client and regulatory audits as needed.
Requirements
  • 8+ years of relevant experience or equivalent.
  • Bachelor's degree in a science-related field or equivalent experience.
  • Knowledge of 21 CFR Part 11 and ISPE GAMP5 is required.
  • Knowledge of cGMP requirements, PTC guidelines, and ISO 17205 is highly desirable.
  • Ability to accurately and reproducibly perform arithmetic, algebraic, and geometric calculations.
  • Ability to record data accurately and legibly.
  • Ability to use judgment as dictated by the complexity of the situation.
  • Ability to understand and follow verbal or demonstrated instructions.
  • Ability to work effectively as part of a team and exhibit effective interpersonal skills.
  • Ability to receive, comprehend, and effectively communicate detailed information through verbal and written communication.
Working Conditions

The ideal candidate will be able to work in an office environment with minimal noise conditions and be able to work in a lab setting with biohazards and various chemicals. The ability to stand, sit, and walk for long periods of time is also required.



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