MS&T Director, Validation Lead Steriles

Thermo Fisher Scientific; North Carolina; Remote; USD 200,000 - 240,000; Full time

Job summary

Thermo Fisher Scientific seeks a talented MS&T Director, Validation Lead Steriles to lead validation strategies in sterile manufacturing processes. This role offers the chance to shape regulatory compliance and collaboration across global teams. Ideal candidates will possess an MSc in a scientific field and over 10 years of GMP experience in pharmaceuticals.

Qualifications

• 10+ years of experience in GMP manufacturing required.
• Strong understanding of Pharma and Regulatory aspects.
• Ability to influence and lead cross-functional teams.

Responsibilities

• Set global procedures for cleaning and process validation.
• Support sites during Regulatory inspections.
• Develop strategy for continued process verification.

Skills

Process understanding

Aseptic manufacturing

Regulatory compliance

Technical support

Education

MSc or equivalent in Pharmacy or related field

Job description

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Work Schedule

Standard Office Hours (40/wk)

Environmental Conditions

Office

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.
  
  

Seniority level

• Seniority level

  Not Applicable

Employment type

• Employment type

  Full-time

Job function

• Job function

  Production, Supply Chain, and Manufacturing

• Industries

  Pharmaceutical Manufacturing and Biotechnology Research

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