The Process Engineer IV will execute and oversee advanced engineering functions such as process design, scale-up, and meticulous documentation control. This position will collaborate closely with cross-functional teams, including R&D, Quality Assurance, and Production, providing technical leadership and expertise to drive process improvements, enhance operational efficiency, and ensure compliance with industry standards such as cGMP and FDA regulations.
Responsibilities
- Develop batch records for client-specific formulation and filling operations. Oversee processing operations (ENG and GMP) including equipment preparation, bulk product formulation, sterile filtration, and filling support, to facilitate process design and internal technology transfer.
- With senior/managerial engineering support, operate as an SME for GMP investigations (e.g. CAPA, departures, CCRs) as well as finalize closure reports for departures that are assigned to process engineering. Direct client interaction for routine discussions, summarizing engineering-related work completed verbally as well as written. Client communication will be supported by more senior- level engineers, as needed
- Identify and specify process-specific equipment needed for clients’ tech transfer and develop techniques and process parameters specific to the client's product while maintaining critical product attributes. Author instructions for the operation of equipment and for detailing process flows in the cleanroom facility.
- Develop new manufacturing processes to meet client requirements. Always adhere to safety requirements. Raise deviations in the process to the attention of the shift supervisor, engineering manager, and/or quality assurance.
Qualifications
- Bachelor's degree or equivalent experience in Mechanical Engineering
- Familiarity with process control
- Excellent written and oral skills
- Ability to work independently and collaboratively
Other Qualifications:
- Must pass a background check
- Must pass a drug screen
- May be required to pass Occupational Health Screening
- May be required to obtain and maintain gowning certification
- May be required to obtain and maintain media qualification
