MS&T Director - Sterile Technical SME (Isolators - VHP)

Thermo Fisher Scientific; Italia; Remoto; EUR 60.000 - 90.000; Tempo pieno

Descrizione del lavoro

A leading company in the pharmaceutical industry is seeking an expert in Isolator Technology to join their remote team. This role involves providing technical support, collaborating on standards, and ensuring compliance with GMP and regulatory requirements. Ideal candidates will have an MSc and over 10 years of experience in GMP manufacturing, along with strong leadership and communication skills.

Competenze

• 10+ years of professional experience in GMP manufacturing.
• Proven process understanding in Pharma and Regulatory aspects.
• Ability to influence and build cross-functional teams.

Mansioni

• Provide SME expertise in Isolator Technology for pharmaceutical processes.
• Support troubleshooting and harmonize technical processes across units.
• Collaborate with teams to implement new technologies.

Conoscenze

Aseptic manufacturing

Decontamination Cycles

Environmental Monitoring

Cycle Development

GMP

Regulatory compliance

Technical leadership

Formazione

MSc in Pharmacy, Pharmaceutical Technology, Chemistry, or related field

Descrizione del lavoro

Work Schedule

Standard Office Hours (40/wk)

Environmental Conditions

Office

Job Description

Position Summary

Join our distributed technical team specializing in Isolator Technology on a full-time remote basis. Provide expertise in Isolator Technology, aseptic pharmaceutical processes, and process technologies.

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.

Key Responsibilities

• Manufacturing Support
• Provide SME expertise in Isolator Technology for pharmaceutical processes – help establish division strategy, develop global standards, and drive harmonization within the DPD sterile sites.
• Offer significant expertise on common topics related to Isolator Technology, including Decontamination Cycles, Environmental Monitoring, and Cycle Development.
• Support sites in troubleshooting/root cause investigations by providing second-level specialist expertise and harmonizing related technical processes across units.
• Review sterile site aseptic practices and set plans for improvements.
• Collaborate with sterile manufacturing site Teams to successfully implement new technologies and ensure timely product launches.
• Continuously monitor GMP, EU, and FDA regulatory changes and requirements.
• Provide expert technical support in aseptic manufacturing, validation, new technologies, and sterilization; facilitate IQ, OQ, and PQ equipment and process qualifications upon request.

Stewardship for Aseptic Network & New Product Launch

• Act as the Network SME for collaborating with Local and global MSAT networks to define and implement new technical standards.
• Ensure internal and external benchmarking to stimulate and extend knowledge, growing know-how among associates.
• Author and implement GOPs for assigned technologies.

Qualifications and Requirements

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