Qualifications

• Bachelor's degree in STEM, Biomedical Engineering, or Chemical Engineering preferred
• 8+ years of validation experience in pharmaceuticals or biotechnology
• Strong hands-on experience with critical process equipment (bioreactors, filtration, chromatography, UF)
• Proven leadership in validation teams or shift-based execution
• Thorough understanding of GMP/GDP standards
• Proficient in eVal and familiarity with ValGenesis preferred
• Experience with temperature mapping, particularly using Ellab

Responsibilities

• Lead CQV execution activities across various systems and workstreams
• Coordinate execution priorities to recover schedule slippage
• Interface with QA, Engineering, and Operations to resolve issues in real-time
• Oversee IQ/OQ protocol execution and operational verification
• Support and review drawing walkdowns, equipment/component verification, and MOC/weld verification
• Provide oversight for temperature mapping and validation activities
• Support development of SIP/CIP cycle as required
• Ensure documentation is audit-ready per GMP/GDP standards
• Drive identification, escalation, and resolution of deviations

Benefits

• Opportunities for growth in a fast-paced, people-focused environment
• Competitive pay with performance-based incentives
• Company-paid life, short-term, and long-term disability insurance
• Comprehensive medical, dental, and vision plans
• Flexible spending account, commuter benefits, and health savings account
• 401(k) retirement plan with employer matching
• Rollover Paid Time Off and Paid Holidays
• Tuition reimbursement and team social activities
• Employee recognition and referral programs
• Paid parental leave and bereavement support