Job Description
Process Engineer IV - Camarillo, CA
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.
We proudly offer
• 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
• And more!
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. 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
• This role does not have supervisory responsibilities, yet it may involve mentoring, guiding, and advising
Required
• 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
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
• May be required to wear a respirator
Pay range: $119,000-$138,500/year
We do not accept unsolicited assistance from any headhunters or recruitment firms for any of our job openings. All resumes or profiles submitted by search firms to any employee at Curia, in any form without a valid, signed search agreement by an authorized signatory in place for the specific position, approved by Talent Acquisition, will be deemed the sole property of Curia. No fee will be paid in the event the candidate is hired by Curia because of the unsolicited referral.
All interested applicants must apply online. Please be aware of scammers. Curia will only send offer letters and requests for sensitive personal information from a curiaglobal.com email address.
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