Sr Principal Eng - Process Engineering

Position Summary

GET PE – Synthetics Drug Product Manufacturing Senior Principal Engineer – responsible for leading technical strategy and design for synthetic drug product manufacturing processes across the global site network.

Responsibilities

• Lead the intake, scoping, prioritization, and resolution of synthetic controlled bioburden drug product manufacturing technical requests across global sites.
• Lead and influence early‑phase process design and domain expertise for oral solid dose (OSD) products, covering both batch and continuous manufacturing platforms and new innovative drug product forms.
• Lead and influence early‑phase process design and domain expertise for bioavailability enhanced technologies, including amorphous solid dispersions (ASD) with a strong emphasis on spray drying, and other technologies such as Self‑Emulsifying Drug Delivery Systems (SEDDS) and related innovative intermediate formulation approaches.
• Ensure robust, fit‑for‑purpose process design while promoting standardization and platform approaches when they add value.
• Provide expert input and alignment on key process, equipment, and technology selection decisions for drug product manufacturing.
• Actively collaborate with functions such as R&D, MSAT, Quality, EHS and Operations leads across synthetic drug product sites.
• Find opportunities for harmonization, shared solutions, and best‑practice exchange across the network.
• Foster a culture of collaboration to reduce duplication, accelerate implementation, and improve speed‑to‑market.
• Maintain strong connections with industry experts and external networks (e.g., ISPE) to bring innovative manufacturing solutions into the organization.
• Ensure alignment with enterprise strategies, GMP requirements, and technology roadmaps.
• Collaborate with external manufacturing teams to prioritize support and resolve issues for high‑impact programs and partners.

Qualifications – Required

• Minimum Master’s degree in Engineering, Pharmaceutical Sciences, or a related technical field.
• Minimum 10 years of relevant experience in synthetic controlled bioburden drug product manufacturing, focusing on oral solid dose (OSD) processes and innovative technologies (e.g., semi‑solid).
• Expertise in bioavailability enhanced technologies, including amorphous solid dispersions (ASD) with deep knowledge of spray drying, and SEDDS or similar formulation approaches.
• Experience with OSD controlled bioburden manufacturing, including batch and continuous processes and associated equipment.
• Strong understanding of cGMP environments and regulatory expectations for controlled bioburden drug product manufacturing; aseptic capability is a plus.
• Proven track record of leading multifunctional teams and influencing technical decisions in complex global organizations.
• Ability to support early‑phase design, detail design, start‑up processes, and commissioning & qualification (C&Q) of controlled bioburden and aseptic equipment.
• Experience with inherently safe containment design for components with low exposure level.
• Drive adoption of digital and data‑enabled solutions for drug product manufacturing, including real‑time monitoring, advanced process control, analytics, modelling, and smart manufacturing use cases.
• Strong customer management and communication skills, with ability to influence across sites, functions, and external partners.
• Strategic attitude combined with hands‑on technical capability.
• Intellectual curiosity to challenge the status quo, influence without authority, and cultivate an inclusive, collaborative culture.
• Proficiency in written and spoken English.
• Willingness to travel up to 25% domestically and internationally.

Preferred

• Strategic attitude combined with hands‑on technical capability.
• Intellectual curiosity to challenge the status quo, influence without authority, and cultivate an inclusive and collaborative culture.
• Additional languages (Dutch, Spanish, Italian) are an advantage.

Required Skills

• Agile Decision Making
• Coaching
• Consulting
• Corrective and Preventive Action (CAPA)
• Crisis Management
• Cross‑Functional Collaboration
• Disruptive Innovations
• Emerging Technologies
• Industrial Hygiene
• Lean Supply Chain Management
• Process Control
• Process Engineering
• Product Costing
• Program Management
• Project Schedule
• Science, Technology, Engineering, and Math (STEM) Application
• Tactical Planning
• Technical Credibility
• Technical Research

Benefits

Pay Range (primary location): €96,000 – €165,025. Italy: €70,700 – €122,015.

• Annual bonus with target percentage of pay, based on performance.
• Vacation days.
• Parental leave (minimum 12 weeks).
• Bereavement leave.
• Caregiver leave.
• Volunteer leave.
• Well‑being reimbursement.
• Programs for financial, physical and mental health.
• Service anniversary and recognition awards.
• Insurance plans for employees and eligible dependents.

This information is for informative purposes only. Amounts and actual benefits may vary by location and are subject to change.