What are the responsibilities and job description for the Supervisor of Process Validation position at Lead Candidate?
Supervisor of Process Validation
WHO?:
Are you a Process Validation expert looking to expand your leadership skills? INCOG BioPharma is expanding their Process Validation team with their Supervisor of Process Validation role. This role 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).
WHAT?:
This role will report into the AD of TSMS (Technical Services and Manufacturing Sciences), and is integral in delivering hands-on technical expertise with stellar people management skills.
The role responsibilities are, but are not limited to:
- 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
- Represent the organization as technical expert during regulatory inspections, agency interactions, and client audits, and as senior technical advisor to key clients
- 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, etc.
- Oversee comprehensive root cause investigations for complex manufacturing issues and lead CAPA development initiatives
YOU:
Ideally, candidates will have a Bachelor’s degree in Science/Engineering, with a Master’s degree preferred. They will also have:
- 5 years of GMP experience
- 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
- Strong leadership and team development capabilities with experience in establishing validation standards and training programs
Interested? Send us your resume at apply@leadcandidate.com or you can find more information on our website.
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.