No. of Openings: 1
Location: Germantown, Wisconsin 53022
Job Type: Full-Time
Salary: $70,000.00 - $79,999.00
Industry: Pharmaceutical / Biotech
Experience: 2-5 years
Education: Bachelor's Degree
Relocation Assistance: No - Local candidates only
Candidate Guarantee Terms: 90 days
Work Eligibility: US Citizen
The Validation Engineer establishes validation policies and procedures ensuring compliance with global regulations and company standards.
KEY RESPONSIBILITIES AND DUTIES:
Works with leaders to schedule and execute validation activities.
Identifies/resolves validation issues and designs validation test plans.
Authors and follows up on closure documentation for IQ, OQ and PQ.
Creates and reviews SOPs and related manufacturing process documentation.
Performs duties related to Corrective and Preventative Action (CAPA) plans, deviations and Change Control (CC).
Provides validation, facilities and utilities support for new or modified equipment used to manufacture new active pharmaceutical ingredients.
Prepares summary, deficiency and discrepancy reports, gap analysis, risk analysis, FMEA and traceability matrices.
Assists with development of validation master plans, CSV, SDS, URS and design specifications.
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