About the position
The Process Engineer II is responsible for facilitating technology transfer of client processes and executing engineering functions to support manufacturing. This role functions as a program lead with direction from department leadership. The Engineer II is responsible for leading process design and scale up, problem investigation and mitigation, and general process improvement. The Engineer provides guidance and instruction to supporting team members on tasks directly related to their project, in addition to providing training for new team members. Join our talented workforce, where a commitment to excellence and a customer focused attitude is everything. We pursue excellence because our work has the power to improve patients' lives with the pharmaceuticals we develop and manufacture.
Responsibilities
- Develops batch records and leads process activities for client-specific formulation and filling operations for at least one client.
- Oversees critical operations (ENG and GMP) including equipment preparation, bulk product formulation, sterile filtration, and filling support.
- Acts as an SME for GMP investigations (CAPA, departures, CCRs) from initiation to closure.
- Finalizes closure reports for the departures that are assigned to process engineering.
- Direct client interaction for routine discussions, summarizing engineering-related work completed verbally as well as written.
- Identify and specify process-specific equipment based on facility, client, and program needs.
- Author instructions for the operation of equipment and for detailing process flows in the cleanroom facility.
- Develop new procedures to meet facility and client requirements.
- Adhere to safety requirements at all times.
- Designs and provides training on operation tasks, like those captured in SOPs or work instructions.
- Provides training on client programs and processes.
- Professionally communicate deviations to the appropriate leaders involved in the production process.
- Read/interpret SOPs to ensure compliance.
- Maintain up to date trainings.
- Other duties as assigned.
Requirements
- Bachelor's degree in Biology, Chemical Engineering, or related field of study.
- Minimum of three (3) years' experience in Pharmaceutical, Biotech or related industry.
- Process engineering experience, required.
- Experience with aseptic fill/finish, preferred.
Nice-to-haves
- Familiarity with aseptic technique.
- Familiarity with cleanroom personnel flows.
- Knowledge of process flows - Disposable's strategies, filtration, mixing strategies, fluid transfer to and from various vessels.
- Working knowledge of process engineering processing aids such as sanitary connections, valves, and pharmaceutical process design.
