MS&T Director, Validation Lead Steriles

Thermo Fisher Scientific Inc.; Swindon; Remote; GBP 80,000 - 120,000; Full time

Job summary

Join a leading company as an MS&T Director, Validation Lead Steriles, where you will leverage expert knowledge in validation strategies within the biotech industry. This pivotal role involves collaborating with site leaders to ensure compliance with regulatory standards, leading to improved product quality and operational efficiency. You will have significant responsibilities in training and process verification while being a key player in new product launches.

Qualifications

• 10+ years in GMP manufacturing; experience in MST roles required.
• Proven understanding of Pharma and regulatory aspects.
• Confident communicator and able to influence cross-functional teams.

Responsibilities

• Develop validation strategies for cleaning and process.
• Support Regulatory inspections to ensure compliance.
• Own the Training Curriculum for cleaning and process validation.

Skills

Communication

Leadership

Process Validation

Technical Expertise

Education

MSc in Pharmacy or related field

Job description

Work Schedule

Standard Office Hours (40/wk)

Environmental Conditions

Office

Job Description

Position: MS&T Director, Validation Lead Steriles

Reports To: DPD Division MSAT Head

Location: Remote US / EU

Preferred Locations:

• North Carolina (US): Greenville
• France, Bourgoin
• Italy: Monza & Ferentino
• UK: Swindon

These locations are key sites for our operations.

FTE Responsibility: No direct resources, leads influentially through the matrix across sterile network globally

Position summary

Join our dynamic DPD MSAT distributed team as a Validation Lead Steriles! This outstanding opportunity offers the chance to bring to bear your deep specialist knowledge and expertise in validation for both cleaning and process. You’ll work closely with site General Managers and their Site Leadership Teams to develop validation strategies for new and existing processes. Your role will be pivotal in setting validation standards aligned with up-to-date Regulatory mentorship, reducing compliance risks, and building standard methodologies across our sterile drug product sites.

Key responsibilities

Manufacturing Support:

• Set global procedures & templates for cleaning and process validation documentation and validation master plan.
• Develop strategy for continued process verification (CPV) and annual monitoring batches.
• Support sites during Regulatory inspections to ensure flawless 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.

Stewardship for Aseptic Network & New Product Launch:

• Act as the Network SME for collaborating with the Local and global MSAT network.
• Assure necessary benchmarking internally and externally to stimulate knowledge expansion.
• Author and implement GOPs for assigned technology.

Qualifications and requirements

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