The Process Engineer is responsible for ensuring that manufacturing processes are efficient, cost-effective, reliable, and safe. This position is central to the design, implementation, monitoring, and continuous improvement of production processes. The Process Engineer works cross-functionally to troubleshoot and resolve issues, supports technology transfer and scale-up activities, and drives process optimization projects within a regulated or manufacturing environment.
MAIN RESPONSIBILITIES
- Develop, optimize, and maintain production processes to meet yield, quality, and efficiency targets.
- Analyze process data to identify trends, inefficiencies, or deviations, and develop solutions for continuous improvement.
- Troubleshoot day-to-day process problems in collaboration with operations, quality, and maintenance teams.
- Prepare and update key process documentation such as process flow diagrams (PFDs), P&IDs, SOPs, and batch records.
- Specify, evaluate, and implement new equipment or process changes, including piloting and scale-up activities.
- Participate in root cause analysis investigations for process deviations and implement corrective or preventive actions.
- Support startup, commissioning, and qualification of new or modified production equipment and systems.
- Conduct process risk assessments (HAZOP, FMEA) and ensure processes comply with safety and regulatory standards.
- Lead or assist in process validation efforts as required (e.g., protocol drafting, execution, and reporting).
- Provide technical support for manufacturing, including hands-on problem-solving and operator training.
- Collaborate with project teams on capital projects, transfer of technology/knowledge, and process improvement initiatives.
- Monitor and report on process metrics, and recommend adjustments as needed to meet production goals.
- Identify and implement cost reduction projects without compromising quality or compliance.
EDUCATION/QUALIFICATIONS
- Bachelor’s degree in Chemical, Mechanical, Biochemical Engineering, or a related field.
- Approximately 5 years’ experience as a process engineer in a manufacturing or regulated (e.g., pharma, biotech, food, chemical) environment.
- Strong knowledge of process troubleshooting, optimization techniques, and manufacturing operations.
- Familiarity with key process documentation (PFDs, P&IDs, SOPs, validation protocols).
- Good understanding of safety, quality, and regulatory requirements (e.g., cGMP,).
- Solid analytical, organizational, and communication skills.
- Ability to work both independently and collaboratively in cross-functional teams.
- Proficiency in Microsoft Office; familiarity with process simulation or modeling tools is a plus.
- Willingness to work on-site and respond to process-related issues as needed.