Senior Process Engineer: GMP Fill/Finish & Tech Transfer

Curia; Camarillo (CA); On-site; USD 119,000 - 139,000; Full time

Benefits offered by this job

Generous benefit options (eligible on

Paid training, vacation and holidays (

Career advancement opportunities

Education reimbursement

401K program with matching

Learning platform

And more!

Job summary

Curia is seeking a Process Engineer IV in Camarillo, CA to lead advanced engineering functions, including process design, scale-up, and meticulous documentation control. You will collaborate with R&D, QA, and Production to drive process improvements and ensure compliance with cGMP and FDA standards.

As an SME for GMP investigations, you will interact with clients and senior engineers to communicate results and support tech transfer.

Qualifications

• 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.

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.
• 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.
• 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

Skills

Process design

Documentation control

Cross-functional collaboration

Technical leadership

Education

Bachelor's Degree in Biology or Chemical Engineering

Job description

Curia is seeking a Process Engineer IV in Camarillo, CA to lead advanced engineering functions, including process design, scale-up, and meticulous documentation control. You will collaborate with R&D, QA, and Production to drive process improvements and ensure compliance with cGMP and FDA standards.

As an SME for GMP investigations, you will interact with clients and senior engineers to communicate results and support tech transfer.