• MS&T Director, Validation Lead Steriles

    ThermoFisher Scientific (Wilmington, NC)


    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

    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.

     

    Thermo Fisher Scientific is an EEO/Affirmative Action Employer and does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability or any other legally protected status.