MS&T Director, Validation Lead Steriles

Position Overview

• Location Type: Remote US / EU
• Job Type: Full time
• Work Schedule: Standard Office Hours (40/hr week)
• Environmental Conditions: Office
• Salary: Not Specified

This role serves as the Validation Lead for Steriles within the DPD MSAT distributed team. The position focuses on providing specialist knowledge and expertise in cleaning and process validation. The Validation Lead will collaborate with site General Managers and their Site Leadership Teams to develop validation strategies for new and existing processes. The goal is to establish validation standards aligned with current regulatory guidance, mitigate compliance risks, and build standardized methodologies across sterile drug product sites globally.

Reporting To: DPD Division MSAT Head FTE Responsibility: No direct reports; leads influentially through a matrix structure across the global sterile network. Preferred Locations: North Carolina (US): Greenville; France: Bourgoin; Italy: Monza & Ferentino; UK: Swindon.

Key Responsibilities

Manufacturing Support:

• Set global procedures and templates for cleaning and process validation documentation and validation master plans.
• Develop strategies for continued process verification (CPV) and annual monitoring batches.
• Support sites during regulatory inspections.
• Provide expert technical support in aseptic manufacturing, validation, new technologies, and sterilization.
• Continuously monitor GMP, EU, and FDA regulatory changes.
• Partner with Engineering and IT to define the process validation/equipment/systems qualification interface.
• Identify and drive opportunities for improvement in process effectiveness, product quality, and operating efficiency.
• Own the Training Curriculum for cleaning and process validation and technologies.

Aseptic Network & New Product Launch Stewardship:

• Act as the Network Subject Matter Expert (SME) for collaboration with the local and global MSAT network.
• Ensure necessary benchmarking, both internally and externally, to stimulate knowledge expansion.
• Author and implement General Operating Procedures (GOPs) for assigned technology.

Qualifications and Requirements

• MSc or equivalent experience in Pharmacy, Pharmaceutical Technology, Chemistry, or a related scientific field.
• 10+ years of professional experience in GMP manufacturing.
• Previous experience in relevant MSAT roles is mandatory.
• Proven process understanding (Pharma, GMP, Regulatory aspects).
• Confident communicator, both verbally and in writing.
• Ability to influence others and build cross-functional teams while setting clear business objectives.
• Demonstrated leadership and technical experience.
• Willingness to travel up to 40% internationally, as needed.