Senior Validation Engineer — GMP & Regulatory Excellence

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

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.