Offer summary

Qualifications:

MSc or equivalent in Pharmacy, Pharmaceutical Technology, Chemistry, or related field., Extensive experience in GMP pharmaceutical manufacturing., Strong understanding of GMP, regulatory standards, and validated processes., Proven leadership and communication skills for cross-functional collaboration..

Key responsibilities:

Provide expertise in visual inspection and support global process improvements.

Assist sites with troubleshooting, validation, and implementation of new technologies.

Develop and deliver training programs for site staff on aseptic manufacturing and related technologies.

Collaborate with global teams to establish technical standards and support new product launches.

Job description

Work Schedule

Standard Office Hours (40/wk)

Environmental Conditions

Office

Position: MS&T Director – Sterile Technical SME (Visual Inspection)

Reports To: DPD Division MSAT Head

Location: Remote (EU/US)

Preferred Locations:

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

These locations are key sites for our operations

Position Summary

Work for Thermo Fisher Scientific as a Global Technical SME in Visual Inspection. Contribute to improve visual inspection process globally.

Key responsibilities

Manufacturing Support:

Offer expertise in visual inspection for pharmaceutical processes, assist in strategy creation, set global standards, and ensure consistency in DPD sterile sites
Offer significant expertise on common VI technologies/equipment (Manual/Semi-automatic/Automatic) and Leak Detection systems
Knowledgeable about AI application to AVI (e.g., recipes creation/optimization, support to validation)
Perform process characterization of related pharmaceutical processes to increase robustness and sustainability
Support sites in troubleshooting/root cause investigation by providing second-level specialist expertise and harmonizing related technical processes across units
Review sterile site aseptic practices and set a plan for improvements and adaptations
Work closely with sterile manufacturing site teams to efficiently implement new technologies and ensure timely product launches
Monitor GMP, EU, and FDA regulatory changes and requirements, review industry-specific journals and periodicals
Support projects requiring expertise in aseptic manufacturing and lyophilization technology
Provide technical support in aseptic manufacturing, validation, new technologies, and sterilization; facilitate IQ, OQ, and PQ equipment and process qualifications upon request
Identify and drive opportunities for improvement, suggesting ways to improve process effectiveness, product quality, and operating efficiency
Support the development of Training Curriculum for Site SMEs and assure alignment across sites
Provide training and education on related technologies to site employees

Stewardship for Aseptic Network & New Product Launch:

Serve as the Network SME, collaborating with local and global MSAT networks to establish technical standards for current and upcoming technologies and equipment.
Assure internal and external benchmarking to stimulate knowledge, growing associates' know-how and spreading it across the organization
Author and implement GOPs for assigned technologies

Qualifications And Requirements

MSc or equivalent experience in Pharmacy, Pharmaceutical Technology, Chemistry, or a related scientific field
Significant career experience in GMP manufacturing relevant to the specialist area of expertise
Validated process understanding (Pharma, GMP, Regulatory aspects)
Up to 30-40% travel, as needed
Confident communicator both verbally and in writing
Able to influence others and build cross-functional teams while setting clear business objectives
Proven leadership and technical experience

Required profile