Manufacturing Technical Specialist II (MTS)

Manufacturing Technical Specialist II (MTS) PCI Pharma Services - 2.8 Bedford, NH Job Details Full-time 1 day ago Qualifications Technical documentation Technical report writing Full Job Description Life changing therapies. Global impact. Bridge to thousands of biopharma companies and their patients. We are PCI. Our investment is in People who make an impact, drive progress and create a better tomorrow. Our strategy includes building teams across our global network to pioneer and shape the future of PCI.

Summary of Objective:

The Manufacturing Technical Specialist provides technical (scientific/engineering) knowledge to enable GMP manufacturing, ensure regulatory compliance, inclusive of direct client support. These efforts are directed to support the company's Aseptic and Non-Aseptic manufacturing processes including Pharmaceutical Form/Fill/Finish and Medical Device manufacturing. The incumbent assist with technical transfers by implementing client processes, developing and writing Batch Records as well as Reports for technical studies. The incumbent is also expected to provide Quality system support (own deviations, investigations, excursions, CAPA execution). The incumbent develops, edits and completes additional cGMP documentation (SOP's, material specifications, training) related to manufacturing operations and client specifications. The MTS Specialist II participates and provides input and feedback for the PCI EHS Program to meet Health and Safety regulations and OSHA requirements in all duties.

Essential Duties and Responsibilities:

Provide technical Support for technical transfer of new processes with minimal supervision. Utilize manufacturing and GMP process knowledge and investigation skill sets to identify and resolve manufacturing issues, improve process operations and affect positive change. Author Production Batch Record modules and SOPs for new processes, perform revisions/edits for existing records. Conducts complex investigations, document revisions and/or document management including batch production records, manufacturing procedures, and cross functional procedures. Assist in specifying materials and components with cross functional teams. Work with manufacturing Operations to develop and maintain production records compliance. Train manufacturing personnel as needed to support Quality systems and batch documentation. Support technical studies to support cGMP process/material implementation as well as for quality system investigations/root cause analysis. Perform root cause analysis for investigations, perform risk assessments when required. Own and manage assigned manufacturing internal investigations, CAPAs, and supporting Quality documentation. Meet and interact with clients, as needed, to complete, discuss, and document client decisions regarding, for example, manufacturing materials and processes related to Batch Records. Practices and promotes safe work habits and adheres to PCI's safety procedures and guidelines. Perform other duties as required to support PCI GMP Operations activities. TRAVEL -