GMP Production Operator II — Shape Life-Saving Therapies

Curia Aalborg ApS; Camarillo (CA); On-site; USD 52,000 - 66,000; Full time

Benefits offered by this job

Generous benefit options

Paid training, vacation and holidays

Career advancement opportunities

Education reimbursement

401K program with matching

Job summary

Curia is seeking a Production Operator II in Camarillo, CA to support timely manufacturing of parenteral, cGMP products in an aseptic environment. You will execute complex formulations, operate and monitor formulation equipment, and ensure GMP, safety and data integrity in all activities.

The role involves process scale-up support, technical transfer, and documentation updates, with a focus on producing sterile quality products.

Qualifications

• High school education or equivalent requirement.
• Associate's degree or biotechnology certificate; biotechnology certificate may be substituted for the equivalent combination of experience in the industry.

Responsibilities

• Execute and support complex formulations and compounding operations according to batch records and SOPs.
• Operate and monitor formulation equipment including mixers, tanks, filtration systems, and transfer systems.
• Ensure adherence to GMP, safety, and data integrity requirements.
• Support process scale-up, engineering runs, and GMP batches.
• Assist in drafting and revising SOPs, batch records, and protocols.
• Review batch record documentation for accuracy and completeness.
• Support technical transfer and process documentation updates.
• Prepare and sanitize equipment for clean rooms, product compounding, and filling according to preparation list, including disassembly/assembly.
• Load and unload steam sterilizers and washers according to diagrams and instructions.
• Record all procedures in logbooks following completion and complete/correct batch records.
• Sanitize aseptic/controlled production areas to ensure microbial contamination is reduced to safe level on inanimate surfaces.
• Bubble point test filters and read/interpret SOPs to ensure compliance.

Education

High school education or equivalent

Associate's degree or biotechnology certificate

Job description

Curia is seeking a Production Operator II in Camarillo, CA to support timely manufacturing of parenteral, cGMP products in an aseptic environment. You will execute complex formulations, operate and monitor formulation equipment, and ensure GMP, safety and data integrity in all activities.

The role involves process scale-up support, technical transfer, and documentation updates, with a focus on producing sterile quality products.