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JOB SUMMARY
The Development Engineer II independently supports and executes process development and scale-up activities for APIs and intermediates. This role applies engineering principles to design, optimize, and troubleshoot chemical processes from laboratory through pilot and early commercial manufacturing. This role demonstrates growing technical depth, increasing ownership of assigned projects, and the ability to collaborate cross-functionally to support safe and efficient scale-up.
DUTIES AND RESPONSIBILITIES
- Design and execute laboratory and pilot-scale experiments for reactions, extractions, distillations, crystallizations, filtrations, and drying operations.
- Develop and reconcile mass balances from laboratory through pilot scale; support commercial-scale projections.
- Evaluate process parameters and identify opportunities for optimization, yield improvement, and cycle-time reduction.
- Prepare process flow diagrams, material balances, and supporting technical documentation.
- Support pilot plant campaigns and initial manufacturing batches, including monitoring critical process parameters.
- Assist in preparing and reviewing batch records and scale-up documentation.
- Troubleshoot process issues during demonstration and first commercial runs.
- Collaborate with Manufacturing, Quality, and EHS to ensure safe and compliant operations.
- Identify potential safety risks related to chemical hazards, reactions, and processing steps and recommend mitigation strategies.
- Review safety data (e.g., SDS, hazard evaluations, dust hazard information) in collaboration with senior engineers.
- Support environmental and emissions documentation and ensure adherence to GMP and company safety standards.
- Support Quality by Design (QbD) initiatives, including participation in design of experiments (DoE) and evaluation of critical process parameters (CPPs).
- Analyze process data to support investigations and continuous improvement efforts.
- Contribute to technical reports and project summaries for internal and client review.
- May perform other duties as assigned.
EDUCATION AND EXPERIENCE
- 2-5 years of relevant process development or manufacturing experience;
- Bachelor's degree in Chemical Engineering or related engineering discipline required.
COMPETENCIES/SKILLS
- Solid understanding of chemical engineering principles including mass and energy balances.
- Experience with laboratory and pilot-scale unit operations.
- Ability to independently analyze data and draw technical conclusions.
- Working knowledge of GMP manufacturing environments preferred.
- Strong communication and cross-functional collaboration skills.
- Proficiency in Microsoft Excel and basic data analysis tools.
WORKING CONDITIONS
On-site laboratory, office and pilot plant. Shift coverage (day, swing, night) will be periodically required. Periodically participates in production support that may include nights, weekends, and holidays. This role may involve work in laboratory or manufacturing environments with potential exposure to chemicals or other regulated substances. As a condition of employment, incumbents may be required to participate in employer-provided medical surveillance programs in accordance with applicable regulatory requirements and company policy.
PHYSICAL CONDITIONS
Must be able to lift 25 lbs.
This job description does not constitute a contract of employment or otherwise limit employment-at-will rights at any time. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions of the role, consistent with applicable law.
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