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Senior Validation Engineer

$82.7k - $137.9k

Scorpion Therapeutics

What You Will Achieve: Evaluate, review, and approve validation master plans, protocols, and reports to ensure compliance with company standards and regulatory requirements. Troubleshoot validation issues for equipment and performance processes. Conduct statistical analysis of testing results and process anomalies; support Quality Investigations with high-level data analysis. Write, review, and approve validation process documents and technical reports per Pfizer Quality Standards. Contribute to moderately complex projects; plan short-term work activities. Manage Quality systems (Change Control, Quality Agreement, Documentation, Investigations) and coordinate testing with functional groups. Maintain the Site Validation Master Plan; support regulatory audits; represent engineering validation. Support product transfers, new product development, regulatory queries, cost improvement projects, and Cleaning Validation; integrate validation schedules into production and participate in deviation investigations. Here Is What You Need (Minimum Requirements): High school diploma (8+ yrs) or associate’s (6+ yrs) or BA/BS (2+ yrs) or MBA/MS (any relevant years). Proven GMP expertise. Strong working knowledge of quality systems and processes. Familiarity with Global Document Management System, SAP, and Quality Tracking System. Excellent verbal and written communication. Ability to work independently and in a team. Bonus Points (Preferred Requirements): Validation/qualification expertise for pharma processes/equipment/utilities/facilities/computer systems. Sterile products and medical devices experience. Strong analytical/problem-solving; organizational/time management; ability to mentor. Regulatory audit/compliance experience. Experience using AI tools (e.g., ChatGPT, Microsoft Copilot) with responsible AI practices. Physical/Mental Requirements: Not allergic to penicillin; must be able to aseptically gown; lift 25-30 lbs. Schedule/Travel: Non-standard schedule may be required (weekends/2nd shift/night shift/calls). Minimal travel. Work Location: On Premise Last Date To Apply: August 14, 2026 Compensation/Benefits: Base salary $82,700-$137,900; bonus target 10%. Benefits include 401(k) with Pfizer matching, paid vacation/holidays/personal days, caregiver/parental and medical leave, and health coverage. #J-18808-Ljbffr Scorpion Therapeutics

Vacancy posted 2 days ago
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