Role Summary
The Process Engineer will support the design, introduction, qualification and start-up of new Oral Solid Dosage (OSD) manufacturing process areas and equipment.
Working within the Process Engineering team, the role will provide technical support across project activities including design reviews, commissioning, qualification, validation and operational readiness while developing expertise in OSD manufacturing processes and equipment.
Key Responsibilities
- Act as Process and Equipment SME for assigned OSD manufacturing processes and equipment
- Provide technical support during the design, construction, qualification, operational readiness and GMP introduction of new manufacturing processes and equipment.
- Experience with OSD unit operations is desirable, such as dispensing, blending, granulation, tableting or cleaning.
- Ensure compliance with GMP, safety, quality, 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 support project delivery.
- Support development and review 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 3 years pharmaceutical manufacturing, equipment qualification or process engineering experience.
- A knowledge of OSD manufacturing processes and equipment is desirable.
- Willingness to learn and develop technical expertise in OSD manufacturing processes and equipment, and project delivery.
- Experience working within a GMP-regulated environment.
- Good communication and collaboration 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.
