Process Engineer
Essential job duties
- Develop batch records for client-specific formulation and filling operations
- Perform 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 which 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 clients’ product while maintaining critical product attributes
- Author instructions for the operation of equipment and for detailing process flows in clean room facility
- Develop new manufacturing processes to meet client requirements
- Adhere to safety requirements at all times
- Raise deviations in process to the attention of the shift supervisor, Engineering Manager, and/or Quality Assurance team
Education, experience, certification and licensures
Required
· Bachelor’s degree in Mechanical Engineering, Chemical Engineering or related field
· Minimum 3-5 years’ experience in a cGMP/FDA regulated environment
Preferred
· Advanced degree in related field
· Experience with CIP/SIP
Knowledge, skills and abilities
- Ability to prepare P&IDs/PFDs
- Excellent communication skills
- Meticulous and highly organized
- Aseptic technique, familiarity with clean room personnel flows is desirable
- Knowledge of process flows – e.g. Disposables strategies, filtration, mixing strategies, fluid transfer to and from various vessels is a plus
- Working knowledge of process engineering processing aids such as sanitary connections, valves and pharmaceutical process design
- Computer literate with good working knowledge of spreadsheet software (Visio or equivalent drawing programs a plus)
- Ability to work with a moderate amount of supervision; interact well with clientele as well as interdepartmentally
- Experience with statistically based study designs and related software a plus
Curia is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, or protected veteran status and will not be discriminated against on the basis of disability.