Process Engineer IV

About the role

Execute and oversee advanced engineering functions such as process design, scale-up, and meticulous documentation control. 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.

Curia is a global contract development and manufacturing organization (CDMO) with over 30 years of experience partnering with pharmaceutical and biotech companies to provide life-saving treatments to patients. At Curia, we are on a mission to advance our customers’ therapies from curiosity to cure and ultimately to improve patients’ lives.

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.
• Operate as an SME for GMP investigations (e.g. CAPA, departures, CCRs) with senior/managerial engineering support, and finalize closure reports for departures assigned to process engineering.
• Direct client interaction for routine discussions, summarizing engineering-related work completed verbally as well as in writing. 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.
• Adhere to safety requirements at all times.
• Raise deviations in the process to the attention of the shift supervisor, engineering manager, and/or quality assurance.
• Mentor, guide, and advise team members, though this role does not have supervisory responsibilities.

Requirements

• Bachelor’s Degree in Biology, Chemical Engineering, or a related field.
• Minimum eight (8) years’ experience in a cGMP/FDA regulated environment.
• Experience with aseptic fill/finish, preferred.
• Must pass a background check and drug screen.
• May be required to pass Occupational Health Screening, obtain and maintain gowning certification, media qualification, and wear a respirator.

Benefits

• Generous benefit options (eligible first day of employment).
• Paid training, vacation, and holidays (vacation accrual begins on first day of employment).
• Career advancement opportunities.
• Education reimbursement.
• 401K program with matching contributions.
• Learning platform.

Pay

$119,000-$138,500/year