Validation Engineer II (377)

About the Role

This position leads the commissioning, qualification, and validation (CQV) for a newly announced biologics facility expansion. The expansion includes a dedicated cGMP utilities systems (clean steam, compressed air, nitrogen), a high-speed cartridge filling line, significant utilities upgrades, dedicated formulation and processing suites with Clean In Place (CIP) and Sanitize In Place (SIP) capabilities. The role involves close collaboration with system owners and stakeholders (operations, engineering, laboratories, IT, and quality assurance) to guide CQV activities to a compliant state throughout their lifecycle.

Responsibilities

• Lead the development and execution of commissioning, qualification, and validation protocols for equipment, systems, and critical utilities (compressed air, nitrogen, clean steam).
• Oversee all phases of CQV activities: defining requirements, validation planning, protocol generation, test execution, final summary report generation, configuration documentation, system release, periodic requalification, and system monitoring evaluations.
• Execute validation activities in a timely manner, proactively planning to ensure project completion without avoidable delays.
• Evaluate system change controls for validation impact and support change qualification through relevant change actions.
• Support the development of Standard Operating Procedures for new processes and equipment.
• Manage interactions and achieve results across site functions, including external communication with system vendors.
• Serve as Principal Investigator for validation-related excursions.
• Contribute to the continuous improvement of validation processes and procedures.

Requirements

• Bachelor’s degree in engineering or relevant sciences.
• 8+ years of CQV experience, with 8 years specifically in sterile injectables, combo-devices, or biologics.
• Advanced degrees or certifications relevant to the role (a plus).
• Knowledge of regulatory requirements (cGMP, FDA, etc.).
• Experience authoring, approving, and executing validation protocols for major pharmaceutical manufacturing facilities, utilities, and equipment.
• Self-directed with strong problem-solving, analytical, and technical skills.
• Ability to think strategically and tactically (detail-oriented).
• Experience in a sterile fill-finish facility.
• Experience with single-use components in drug product formulation, sterile filtration, and aseptic filling applications.
• Start-up experience preferred.
• Experience with validation tools and processes, including temperature mapping and use of Kaye Validator.

Skills

• Strong collaborative and influencing skills; ability to work well in a cross-functional, matrixed environment.
• Ability to lead, take ownership, and follow through on assigned projects.
• Demonstrated ability to work in a fast-paced team environment, meet deadlines, and prioritize work.
• Experience in a process improvement environment, including change management and participation in Lean/Six Sigma project teams.
• Ability to own, lead, and drive CQV program improvements and new program implementation for identified validation gaps.
• Ability to work autonomously within established guidelines, procedures, and practices.

Physical Demands and Work Environment

The physical demands described are representative of those required to successfully perform the essential functions of this position. Reasonable accommodations may be made to enable individuals with disabilities to perform the functions.

• Regularly required to speak or hear.
• Frequently required to use hands or fingers, handle or feel objects, tools, or controls.
• Occasionally required to stand, walk, sit, and reach with hands and arms.
• Must occasionally lift and/or move up to 40 pounds.
• The noise level in the work environment is usually low to moderate.