Validation Lead
Core
Lead validation strategy for pharmaceutical manufacturing processes, cleaning, and packaging to ensure product quality and regulatory compliance.
Role type
Senior Validation Lead (Pharmaceutical Manufacturing)
Builds
Validated manufacturing processes, cleaning protocols, and regulatory-ready product launches
Domain
Pharmaceutical manufacturing (Oral Solid Dosage)
Required skills
Process validation, cleaning validation, ongoing process verification, validation master plan management, risk assessment, technical documentation, cross-functional project management, quality systems, applied statistics, global regulatory requirements
Preferred skills
PhD in Chemistry, Pharmacy, Chemical Engineering, or Pharmaceutical Technology
Technologies
Manufacturing Technologies, Process Control, Technology Transfer
Responsibilities
Lead site validation strategy across process, cleaning, and packaging; Own and maintain the Validation Master Plan; Establish and monitor validation performance metrics; Provide technical leadership for risk assessments and investigations; Partner with Engineering, Quality, and IT on equipment and system qualifications; Support product launches and technical transfers; Represent the site during audits and inspections
Seniority
Senior, hands-on IC with strategic influence