MS&T Specialist

Tipo Contratto: Da definire

Purpose of the Role

We are seeking after a proactive and detail-oriented MS amp; 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).



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✔ Da definire