Senior Validation Engineer

Scorpion Therapeutics; Michigan; On-site; USD 83,000 - 138,000; Full time

Benefits offered by this job

401(k) with Pfizer matching

Paid vacation/holidays/personal days

Caregiver/parental and medical leave

Health coverage

Job summary

Scorpion Therapeutics is seeking a Validation Engineer to review and approve validation master plans, protocols, and reports, ensuring compliance with quality standards. You will troubleshoot validation issues for equipment and processes and conduct statistical analysis to support investigations with high-level data insights.

The role requires GMP expertise, strong communication, and the ability to work independently within a team.

Qualifications

• GMP knowledge and experience required.
• Strong understanding of quality systems and processes.
• Familiarity with document management, SAP, and QTS.
• Excellent verbal and written communication.
• Ability to work independently and in a team.

Responsibilities

• Review, approve validation master plans, protocols and reports to ensure compliance.
• Troubleshoot validation issues for equipment and processes.
• Analyze testing results and support investigations with data.
• Prepare validation documents and technical reports to Pfizer standards.
• Coordinate testing with cross-functional groups and manage quality systems.
• Maintain Site Validation Master Plan and assist regulatory audits.
• Support product transfers, new development, regulatory queries, and cost improvements; align schedules with production.

Skills

GMP expertise

Communication skills

Independence & teamwork

Education

High school diploma

Associate degree

BA/BS degree

MBA/MS degree

Tools

Global Document Management System

SAP

Quality Tracking System

Job description

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.