MS&T Specialist

Purpose of the Role

We are seeking after a proactive and detail-oriented MS&T Specialist to support the seamless transfer of new manufacturing processes from other sites to our facility. This role will guide activities from pre-validation through process validation, including documentation for regulatory submissions. You will act as a key point of contact with clients throughout the transfer process and will also be responsible for cleaning validation of process equipment.

Key Responsibilities

• Lead all pre-validation activities for transferred products, including process review, water trials, machinability studies, placebo studies, and engineering runs.
• Coordinate activities on the production floor and interface with analytical labs to support validation work.
• Draft protocols and reports related to pre-validation, process validation, and cleaning validation activities.
• Contribute to the preparation and review of the Master Batch Record.
• Work with sterilizing filter suppliers for filter validation and review related documentation for regulatory submission.
• Serve as the main client interface during the process transfer and validation phases.
• Conduct cleaning validation for equipment in direct and indirect contact with products.
• Perform calculations for cleaning limits and support analytical labs in cleaning method validation.
• Collect field samples for cleaning validation testing.
• Act as Subject Matter Expert (SME) during client and regulatory audits.

Required Qualifications

• Bachelor’s or Master’s degree in Biological Sciences, Chemistry, Pharmacy, CTF (Pharmaceutical Chemistry and Technology), or Chemical Engineering.
• Minimum of 2 years of experience in a similar role within the pharmaceutical industry.

Technical Skills

• Solid understanding of GMP regulations and FDA requirements.
• Experience with aseptic manufacturing processes.
• Strong expertise in cleaning validation practices and documentation.

Soft Skills

• Strong analytical and problem-solving skills.
• Excellent organizational and planning abilities.
• Effective communication and leadership skills.
• Fluent in English (written and spoken).

This announcement is addressed to both sexes, in accordance with Laws 903/77 and 125/91, and to people of all ages and nationalities, in accordance with Legislative Decrees 215/03 and 216/03.

By applying to this announcement you authorize the processing of your personal data in accordance with Article 13 Legislative Decree No. 196 of June 30, 2003 - “Code on the Protection of Personal Data” and Article 13 GDPR 679/16 - “European Regulation on the Protection of Personal Data.”