Sr Principal Eng - Process Engineering
$116,000–$200,100 year
Hybrid · Gurabo, Gurabo, Puerto Rico
Job Summary
Senior Principal Engineer specializing in process engineering for synthetic drug product manufacturing. Leads early design inputs and technical strategy for synthetic drug product manufacturing across global sites, focusing on controlled bioburden processes, oral solid dose platforms, and bioavailability enhanced technologies (e.g., ASD/SPRAY DRYING, SEDDS). Responsible for robust, fit-for-purpose process design, platform standardization, equipment and technology selection, and cross-functional collaboration with R&D, MSAT, Quality, EHS, and Operations. Travel up to 25% and contribute to digital data-enabled DP manufacturing initiatives; works within cGMP expectations and supports both startup and scale-up activities.
Required Qualifications
- Master’s degree or equivalent in Engineering, Pharmaceutical Sciences, or related field
- Minimum 10 years of relevant experience in synthetics controlled bioburden drug product manufacturing
- Experience with oral solid dose (OSD) processes and innovative technologies (e.g., semi-solid)
- Proven expertise in bioavailability enhanced technologies including amorphous solid dispersions (ASD) with spray drying and SEDDS or similar
- Experience with batch and continuous manufacturing and related equipment
- Strong understanding of cGMP regulatory expectations for controlled bioburden drug product manufacturing
- Aseptic capability is a plus
- Ability to lead multi-functional teams and influence technical decisions across sites
- Experience with design/start-up/commissioning/qualification of DP manufacturing equipment
- Willingness to travel up to 25% domestically and internationally
- English proficiency; additional languages are an advantage
- Strong communication and collaboration skills
- Travel and regulatory compliance awareness
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