Staff Validation Engineer, Process and Cleaning

First Shift (Days)

Environmental Conditions

• Adherence to all Good Manufacturing Practices (GMP) and Safety Standards
• Cleanroom: no hair products, jewelry, makeup, nail polish, perfume, exposed piercings, or facial hair allowed
• Office environment
• Some degree of PPE (Personal Protective Equipment) required (safety glasses, gowning, gloves, lab coat, ear plugs, etc.)

Responsibilities

• Lead process validation (PPQ) and cleaning validation activities
• Develop validation strategies for new and existing products and processes
• Author and execute validation protocols and reports
• Perform data analysis to support validation conclusions
• Support change controls, deviations, and CAPAs
• Collaborate with Manufacturing, Quality, and MS&T teams
• Ensure alignment with cGMP and regulatory expectations
• Support internal and external audits and inspections

Requirements

• Bachelor’s degree in Engineering, Chemistry, Life Sciences, or related field
• 8+ years of experience in process and/or cleaning validation
• Experience in sterile/aseptic manufacturing environments (required)
• Strong knowledge of cleaning validation, including residue limits and risk-based approaches
• Experience with lifecycle validation and PPQ

Skills

• Strong understanding of cGMP and regulatory requirements
• Data analysis and problem-solving skills
• Technical writing and documentation expertise
• Ability to manage multiple projects and priorities
• Strong cross-functional collaboration skills