Senior Validation Engineer

Responsibilities

• Lead Commissioning, Qualification, and Validation (CQV) activities for equipment, utilities, and facilities.
• Develop and execute process validation protocols for ADC manufacturing processes, including conjugation, purification, and chemistry operations.
• Author and review validation master plans, protocols, and reports (IQ/OQ/PQ).
• Perform risk assessments and gap analyses to identify validation needs and ensure compliance.
• Collaborate with cross-functional teams including Manufacturing, Quality Assurance, Engineering, and Regulatory Affairs.
• Support cleaning validation and thermal mapping for critical equipment.
• Provide technical support on Quality Event processes such as Change Controls, Deviations, and CAPAs.
• Ensure data integrity and compliance with FDA, EMA, and ICH guidelines.
• Participate in regulatory inspections and provide technical expertise during audits.

Qualifications

• Bachelor’s degree in Engineering, or related scientific field.
• Five (5) years of experience as a Validation Engineer, Equipment Specialist, Engineer, or related role in a commercial manufacturing environment.
• Five (5) years of experience with: GMP and 21CFR Part 11 compliance requirements; Laboratory systems with computer-controlled functions and process validation; Mechanical equipment engineering and software functional testing; Regulatory guidance documents; Generating concise procedures, protocols, and summary reports; Applying sound validation principles; temperature mapping; and Equipment control software.
• Demonstrated ability to write Protocols, Change Controls, Deviations/CAPAs, SOPs, etc. with minimal outside input.
• Demonstrated ability in Project Management dynamics and techniques, ability to contribute to project management efforts with schedule logistics, projections, and resource analysis.
• Ability to support internal and external audits.
• Demonstrated ability to work in a team environment and strong communication skills within all levels of an organization.

Physical Requirements

• Ability to stand for 1-2 hours at a time, sit for 2 to 3 hours at a time.
• Frequently lift and or move objects up to 50 pounds.
• Stand/walk during entire length of shift.
• Use arms, hands and fingers to handle, feel or reach.
• Ability to climb, balance, stoop, kneel, crouch, or crawl.
• Visual abilities including near and far sight, color, peripheral vision, depth and ability to focus.