Pharmaceutical Engineer

We are seeking a collaborative, technically proficient, and user-focused Pharmaceutical Engineer to design, develop, and optimize drug substance and drug product manufacturing processes that enable safe, efficient, and reproducible production of pharmaceutical therapies. The successful candidate will work closely with research, formulation, analytical, manufacturing, quality, and supply chain teams to translate lab-scale work into robust, GMP-ready manufacturing workflows. This role requires strong chemical and pharmaceutical engineering fundamentals, hands-on experience with process development and scale-up, and a pragmatic approach to process characterization, control, and technology transfer.

Key Responsibilities - Pharmaceutical Engineering

• Design, develop, and optimize unit operations and integrated processes for small-molecule and/or biologic drug substance and drug product manufacturing to meet quality, yield, and scalability objectives.

• Plan and execute bench- and pilot-scale experiments to characterize critical process parameters, establish robust operating ranges, and define scale-up strategies using DOE and statistical analysis.

• Develop and maintain process flow diagrams, batch records, SOPs, validation protocols, and technical transfer documentation to support GMP manufacturing and technology transfers.

• Implement in-process monitoring strategies and support analytical method development to inform process control, release criteria, and troubleshooting activities.

• Collaborate with formulation, analytical, and manufacturing teams to select and evaluate equipment (reactors, mixers, granulators, dryers, sterilization systems, filling/finish equipment) and ancillary systems for process integration and scale-up.

• Lead technology transfer activities, including preparing transfer packages, training operators, and supporting startup and qualification at pilot and commercial sites.

• Partner with quality and regulatory teams to ensure processes, validation activities, and documentation meet cGMP expectations and support regulatory submissions as needed.

• Mentor and collaborate with scientists, engineers, operators, and external partners to transfer knowledge, share best practices, and drive continuous process improvement and technology adoption.

• Support process economics, capacity planning, and resource optimization to align process designs with business goals and manufacturing constraints.

• Engage with vendors and equipment suppliers to evaluate technologies, define integration approaches, and ensure vendor deliverables meet functional and regulatory requirements.

Required Qualifications - Skills & Experience

• Bachelor’s degree in Chemical Engineering, Pharmaceutical Engineering, Chemical Biology, or a related discipline; equivalent practical experience will be considered.

• 3+ years of hands-on experience in pharmaceutical process development, scale-up, or manufacturing support for drug substance or drug product operations.

• Practical experience with unit operations relevant to pharmaceutical manufacturing (reaction, crystallization, filtration, drying, milling, granulation, coating, aseptic processing) and process control strategies.

• Experience designing and interpreting DOE studies, process characterization, and statistical analysis to define critical process parameters and acceptance criteria.

• Familiarity with analytical methods used for release and in-process testing (HPLC, dissolution, particle size, moisture analysis, assay/purity) and ability to collaborate with analytical groups to implement appropriate controls.

• Working knowledge of regulatory and quality systems relevant to pharmaceutical manufacturing, including cGMP principles, validation practices, and change control workflows.

• Strong problem-solving and troubleshooting skills across chemical, mechanical, and process control domains.

• Excellent written and verbal communication skills; able to produce clear technical documentation and present findings to cross-functional stakeholders.

Preferred Qualifications - Domain & Tools

• Experience with pilot-scale and GMP manufacturing environments, including technology transfers and operator training.

• Familiarity with process analytical technology (PAT), inline/online monitoring, and automation/control systems (SCADA/DCS) for process control and continuous manufacturing approaches.

• Knowledge of formulation science, aseptic processing, lyophilization, and containment strategies for potent compounds is a plus.

• Experience with single-use systems, scale-down models, process modeling tools, and continuous or intensified processing technologies.

• Advanced degree (MS/PhD) in a relevant field or relevant certifications in pharmaceutical engineering, quality, or regulatory affairs is a plus.

Work Environment & Compensation

• Full-time role within a collaborative, cross-functional product and manufacturing organization; onsite or hybrid presence is expected depending on project needs and facility requirements.

• Competitive salary and benefits package commensurate with experience, including health coverage, retirement plan options, paid time off, and professional development support.

• Opportunities for training, certifications, and career progression in an inclusive, mission-driven organization committed to scientific excellence.

• We are committed to diversity, equity, and inclusion and foster a respectful work environment that supports work-life balance and employee well-being.