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

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

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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
  
  

• 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
  
  

• 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
  
  

• 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
  
  

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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