Role Summary
The Lead Process Engineer will work as Operation Responsible in the Manufacturing department, supporting the design, introduction, qualification and start-up of new Oral Solid Dosage (OSD) manufacturing process areas and equipment.
Working as Process SME within the Process Engineering team, the role will support project delivery from Basis of Design (BD) through commissioning and handover to operations, ensuring process and equipment solutions meet safety, quality, regulatory and business requirements.
Key Responsibilities
- Act as Process and Equipment lead SME for assigned OSD manufacturing processes and equipment
- Provide technical leadership and risk-based decision making during the design, construction, qualification, operational readiness and GMP introduction of new manufacturing processes and equipment.
- Experience with OSD unit operations is preferred, such as dispensing, blending, granulation, tableting or cleaning.
- Ensure process and equipment designs comply with GMP, quality, safety and operational requirements.
- Participate in FAT, SAT and equipment qualification activities where required.
- Support operational readiness, technology transfer and process validation activities.
- Collaborate with project teams, vendors and engineering partners to ensure successful project delivery.
- Support development and approval of project, engineering and operational documentation.
Skills and Experience Required (List the specific skills, qualifications, and experience necessary for the role.
- Bachelor's degree in science or engineering discipline.
- Minimum 5 - 7 years pharmaceutical manufacturing, equipment qualification or process engineering experience.
- Strong knowledge of OSD manufacturing processes and equipment is preferred.
- Experience supporting capital projects, technology transfers or equipment introductions.
- Knowledge of GMP, process validation and Good Engineering Practice (GEP).
- Strong communication, stakeholder management and problem-solving skills.
- Flexibility to work on-site full-time, with availability for travel to equipment supplier sites or other OSD facilities if required.
Work Arrangement
- Expectation is that the person will be on site 5 days per week.
