Senior Validation Engineer

What you'll do

• Lead the planning, execution, and management of large-scale validation projects for manufacturing processes, equipment, and utility systems.
• Author and review comprehensive validation documentation including URS, FRS, DQ, IQ, OQ, PQ, FAT, SAT, and SOPs.
• Ensure all validation activities comply with cGMP, FDA, EMA, ISO, and NRC regulatory requirements.
• Provide technical expertise to troubleshoot, investigate, and resolve manufacturing deviations and root cause issues.
• Manage project timelines and resources while coordinating with cross-functional teams, vendors, and contractors.
• Develop and implement policies and quality standards to meet corporate and regulatory compliance goals.
• Support internal and external audits by providing expert insights and defending validation strategies.
• Conduct gap and risk assessments to identify compliance issues and develop mitigation strategies.

What we're looking for

• Bachelor's degree in Engineering or a related scientific discipline preferred.
• Minimum of 2-4 years of progressive experience in validation within a cGMP pharmaceutical or biotechnology manufacturing environment preferred.
• Demonstrated experience with equipment, process, cleaning, utility, facility, and computer system validation (CSV) preferred.
• Strong understanding of regulatory requirements including FDA, EMA, ISO, and NRC regulations preferred.
• Proven ability to author, execute, and review complex validation protocols and reports like IQ/OQ/PQ preferred.
• Strong project management capabilities including planning, organization, and execution preferred.
• Excellent written and verbal communication skills for collaboration with diverse teams and stakeholders.
• Ability to lift up to 25 pounds.