Sr Principal Eng - Process Engineering - Italy

Experteer Overview

Lead and shape early design and technical strategy for synthetic drug product manufacturing, focusing on controlled bioburden and innovative formulations. Collaborate across R&D, MSAT, Quality, EHS, and Operations to standardize platforms and accelerate speed‑to‑market. Influence equipment and process choices for OSD and new drug product forms, across global sites with a strong emphasis on bioavailability technologies. Join a global engineering team driving technology direction and network‑wide harmonization. Retribuzione / Benefits

Lead intake, scoping, prioritization, and resolution of synthetics bioburden—drug product manufacturing technical requests across global sites Lead early‑phase process design for oral solid dose (OSD) products, including batch and continuous manufacturing Lead early‑phase design for bioavailability enhanced technologies (ASD, spray drying; SEDDS) and related formulations Ensure robust, standardised process designs and promote platform approaches Provide expert input on process, equipment, and technology selection decisions for drug product manufacturing Collaborate with R&D, MSAT, Quality, EHS, and Operations across sites Identify opportunities for harmonization and best‑practice sharing across the network Foster cross‑site collaboration to reduce duplication and accelerate implementation Maintain connections with industry experts and external networks (e.g., ISPE) to bring innovative solutions Ensure alignment with GMP requirements and enterprise technology roadmaps Collaborate with External Manufacturing teams to priority support high‑impact programs Responsabilità

Minimum 10 years of relevant experience in synthetics controlled bioburden drug product manufacturing Strong focus on OSD processes and innovative technologies (e.g., semi‑solid) in drug product manufacturing environments Proven expertise in bioavailability enhanced technologies, including ASD and spray drying, plus SEDDS Experience with OSD controlled bioburden manufacturing, both batch and continuous processes Solid understanding of cGMP and regulatory expectations; aseptic capability is a plus Proven leadership of multi‑functional teams and influencing decisions in large organizations Ability to support early‑design, Start‑up, and C&Q of controlled bioburden equipment Willingness to travel up to 25% domestically and internationally Strong English communication skills Strategic mindset with hands‑on technical capability Requisiti fondamentali

annual bonus vacation days parential leave (min 12 weeks) bereavement leave well-being reimbursement insurance plans

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