Senior Manager of Validation Engineering

About the role

This position leads the Validation department for a sterile injectables manufacturing and packaging facility. The Senior Manager of Validation Engineering will partner with internal and external customers to meet client projects, capital expansion projects, and maintain the validated state. The role requires demonstrated leadership, adaptability, and direct reporting authority.

Responsibilities

• Lead Commissioning, Qualification, and Validation (CQV) activities for utilities, equipment, and systems, including clean utilities, steam sterilization, depyrogenation, manual/automated cleaning, filling, inspection, packaging, and labeling.
• Review and approve CQV lifecycle documentation.
• Develop and maintain validation lifecycle documents, templates, strategies, and policies.
• Support the site change management program, including risk assessments and evaluation of required testing and GMP activities.
• Assess risks in processing steps related to equipment and review validation requirements and design deliverables.
• Interact with clients to provide validation support for product launches, equipment qualifications, and audits.
• Review and provide technical expertise for regulatory filings and support health authority inspections.
• Oversee validation for capital expansion projects, including development and maintenance of CQV schedules.
• Collaborate with cross-functional teams, including Engineering and Operations, to monitor validation and process improvement efforts.

Requirements

• Bachelor’s degree or higher in a STEM discipline (engineering or life science preferred).
• 10+ years of experience in Validation or a related discipline.
• 8+ years of GMP experience in a regulated industry.
• 5+ years of supervisory experience.
• Physically capable of working onsite.

Preferred Qualifications

• Aseptic Fill and Finish experience.
• Expertise in cleaning validation, steam/dry heat sterilization, depyrogenation, inspection, and packaging.
• Strong knowledge of regulatory requirements, risk-based guidance, and industry expectations.
• Continuous improvement certification (e.g., Lean Six Sigma or similar).

About the company

INCOG BioPharma Services is a world-class CDMO specializing in parenteral injectable drugs. The company prioritizes a service-culture mindset, technical excellence, and collaboration to build long-term value for customers. Positions are based in Fishers, IN, and the campus is smoke-free.

INCOG BioPharma is an Equal Opportunity Employer. All employment decisions are based on business needs, job requirements, and individual qualifications without regard to protected characteristics. Qualified applicants must be authorized to work in the U.S. full-time; sponsorship is not provided for this role.