Job Title: Production Process Specialist
Overview
The Role The role is to work as a Subject Matter Expert providing technical leadership on Fill Finish. As a member of the global SME Group, the person employed can be located in one of several offices across Europe. We operate a hybrid work model while the role will require travel to project meetings/workshops as needed.
Responsibilities
To be a technology leader in nominated area(s), which includes:
* Being current in technical and subject knowledge.
* Being aware of upcoming technology changes, developments, innovations.
* Writing papers, presenting at industry conferences.
* Being involved with industry bodies such as the ISPE, ICHEME, BioPhorum.
* Promoting knowledge exchange within the company using appropriate forums, COPs, and teams.
Key Activities
To perform as an SME for early project phases (i.e., Site Master Planning, Feasibility, Concept, and Basic Design phases). This typically involves producing and/or checking early phase project deliverables appropriate to discipline specialty, including scoping and philosophy documents, production throughput analysis, process flow diagrams, equipment requirements, P&IDs, and layout philosophies. Additionally, this may involve technically assisting project teams, undertaking Peer Reviews of work performed by other companies, and performing in-appropriate SME reviews of client sites.
Knowledge Areas
The role requires expertise in various areas, including principles of facility layout, unit operations and technologies, equipment, and facility operations. Specific topics include area classifications, layout adjacencies, segregation approaches, small and large volume parenterals, formulation, freeze/thawing, filling and closing, lyophilisation, sterilisation, sanitisation, filling path inspection, single-use technology, component preparation and support areas, integrity testing, CIP/SIP, clean utility generation and distribution systems, waste systems, deep knowledge of various filling and closing equipment, RABs & Isolators, lyophilisers, inspection equipment, packaging equipment, operating philosophies, lean/Sigma concepts, machine efficiency (OEE), contamination control, GMP regulatory framework, particularly Annex 1 and FDA, basis of design, basis of safety, simulation tools, capacity calculations, tech transfer, commissioning, and qualification.
Requirements
This position requires a bachelor's degree, preferably a master's degree, with 15+ years of experience in design and/or operations and/or process development. A history of wider industry engagement with institutions such as the ISPE and awareness of key industry technology initiatives and direction are also necessary. Excellent knowledge relating to the area of speciality, good understanding of principles of facility layout and design, and good appreciation of appropriate regulatory framework are essential. Good presentation skills and ability to distil down problems to their essence, demonstrate problem-solving ability, and have an ability to innovate are also required.