Sr Principal Eng - Process Engineering
$116,000–$200,100 year
Hybrid · Gurabo, Gurabo, Puerto Rico
Job Summary
Lead early design inputs and technical strategy for synthetic drug product manufacturing across global sites, including OSD and innovative drug product forms; drive robust, fit-for-purpose process design for bioburden-controlled manufacturing and platform technologies such as ASD and SEDDS with emphasis on spray drying; provide input on key process, equipment, and technology selections; collaborate with R&D, MSAT, Quality, EHS, and Operations; promote standardization and platform approaches, harmonization across the network, and adoption of digital/data-enabled solutions; travel up to 25% domestically and internationally; role is onsite/hybrid in Gurabo, PR.
Required Qualifications
- Master’s degree or equivalent in Engineering, Pharmaceutical Sciences, or a related technical field
- Minimum 10 years of relevant experience in synthetics controlled bioburden drug product manufacturing, with a strong focus on oral solid dose (OSD) processes and innovative technologies (e.g., semi-solid)
- Proven expertise in bioavailability enhanced technologies, including ASD (amorphous solid dispersions)—with deep knowledge of spray drying—and SEDDS or similar innovative enabling formulation approaches
- Proven experience with OSD controlled bioburden manufacturing, including batch and continuous manufacturing processes and associated equipment
- Strong understanding of cGMP environments and regulatory expectations for controlled bioburden-drug product manufacturing
- Aseptic capability is a plus
- 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 the adoption of digital and data‐enabled solutions for DP manufacturing, including real‐time monitoring, advanced process control, advanced analytics, model and simulation, and smart manufacturing use cases
- Strong customer management and communication skills, with the ability to influence across sites, functions, and external partners
- Willingness to travel up to 25% domestically and internationally
- Proficiency in written and spoken English
- Leadership of multi-functional teams or projects
- Strategic mindset with hands-on technical capability
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