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

Thermo Fisher Scientific Inc.; Sassari; Remoto; EUR 80.000 - 120.000; Tempo pieno

Descrizione del lavoro

A leading company in pharmaceuticals is seeking a senior expert in Isolator Technology to join their remote technical team. The role involves providing specialized expertise in aseptic processes, supporting regulatory compliance, and fostering collaboration among various teams to improve manufacturing standards and practices. Candidates should possess a relevant master's degree and significant industry experience.

Competenze

• 10+ years' experience in GMP manufacturing.
• Proven process understanding in Pharma and regulatory aspects.
• Ability to influence cross-functional teams.

Mansioni

• Develop and establish division strategy for Isolator Technology.
• Support troubleshooting and process improvements across sterile sites.
• Monitor regulatory changes and ensure compliance with GMP and FDA standards.

Conoscenze

Expertise in Isolator Technology

Aseptic techniques

Regulatory understanding

Troubleshooting

Leadership

Communication

Formazione

MSc in Pharmacy

Pharmaceutical Technology

Chemistry

Descrizione del lavoro

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 :

• UK : Swindon
• France : Bourgoin

These locations are key sites for our operations.

Key Responsibilities

• 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 topics related to Isolator Technology, including Decontamination Cycles, Environmental Monitoring, and Cycle Development.
• Support sites in troubleshooting and root cause investigations by providing second-level specialist expertise and harmonizing related technical processes across units.
• Review sterile site aseptic practices and develop plans for improvements.
• Collaborate with sterile manufacturing site teams to implement new technologies and ensure timely product launches.
• Monitor GMP, EU, and FDA regulatory changes and requirements continuously.
• 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 extend knowledge and grow expertise among team members.
• 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.
• 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 expertise.

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