Sr Principal Eng - Process Engineering

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 SEDDSExperience 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 fondamentaliannual bonus vacation daysparential leave (min 12 weeks) bereavement leavewell‑being reimbursement insurance plans
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