Supervisor of Process Validation
WHO?:
The Technical Services and Manufacturing Sciences (TSMS) Supervisor of Process Validation will lead and manage a team of technical professionals while providing strategic oversight for all facets of technical process validation, process risk management, and continued process verification in accordance with current good manufacturing practices (cGMP). This leadership role combines hands-on technical expertise with people management responsibilities to ensure robust and reliable production processes while developing team capabilities and driving organizational excellence.
WHAT?:
- Supervise, mentor, and develop a team of TSMS process validation engineers (Senior II, Senior I, and Entry Level) while fostering professional growth and technical capabilities
- Conduct performance evaluations, provide coaching and feedback, and implement individual development plans for direct reports
- Lead recruitment, selection, and onboarding of new team members in collaboration with HR and senior leadership
- Manage workload distribution, resource allocation, and project assignments across the team to optimize efficiency and development opportunities
- Foster a collaborative, innovative, and safety-focused team culture aligned with INCOG's values of "All in," "Lean Forward," and "Pull for the Team"
- Represent the organization as technical expert during regulatory inspections, agency interactions, and client audits
- Evaluate, select, and implement new manufacturing technologies, equipment platforms, and digital transformation initiatives
- Author and review complex technical documents including risk assessments, CMC documentation, process validation protocols, CPV plans, and strategic technical reports
- Serve as senior technical advisor to key clients, lead executive-level technical discussions, and actively participate in business development activities
- Oversee comprehensive root cause investigations for complex manufacturing issues and lead CAPA development initiatives
- Ensure all team activities maintain the highest standards of cGMP compliance, quality, and regulatory adherence
YOU:
Ideally, candidates will have a Bachelor’s degree in Science/Engineering, as well as the following:
- Master's degree in Science or Engineering (strongly preferred)
- 5+ years of GMP experience required
- 4+ years of experience in process validation leadership for formulation, aseptic filling and/or combination product (device assembly) processes with demonstrated success in complex programs
- Expert understanding of CMC regulatory requirements and advanced process validation methodologies
- Expert-level analytical and problem-solving skills with proven track record of driving organizational change
- Extensive experience with regulatory compliances, and agency interactions
- Strong leadership and team development capabilities with experience in establishing validation standards and training programs
Don’t meet all the requirements? Don’t sweat! We’re always looking for an excuse to discuss your next opportunity. You might just surprise yourself…
Lead Candidate wholeheartedly supports Equality and Diversity in employment and opposes all forms of unlawful or unfair discrimination on the grounds of age, disability, sex, gender reassignment, sexual orientation, pregnancy and maternity, race, religion or belief and marriage and civil partnerships.
