Manufacturing Technician

The Planet Group; Oceanside (CA); On-site; USD 60,000 - 85,000; Full time

Job summary

The Planet Group is seeking a Manufacturing Technician to execute floor operations under supervision in Oceanside, CA. You will follow batch records, SOPs, and cGMP regulations to ensure safe, compliant production and reliable output.

Strong attention to detail and a safety-first mindset are essential. You will collaborate with MSAT, Facilities & Engineering, and Quality to perform GMP runs, manage materials, and assist in SOP revisions and documentation.

Qualifications

• Follow batch records, SOPs and cGMP regulations.
• Work in a collaborative, cross-functional environment.
• Able to work off-shift hours and weekends.

Responsibilities

• Execute manufacturing processes on the floor under supervision.
• Ensure right-the-first-time performance of process steps.
• Collaborate with MSAT, F&E and Quality on GMP runs.
• Under supervision, weigh raw materials and perform MES/EBS transactions.
• Follow aseptic technique and proper documentation practices.
• Assist in revised SOPs and production records.
• Review in-process GMP documentation for accuracy and completeness.
• Escalate processing and equipment issues as needed.
• Maintain compliance with cGMP regulations for safe operations.

Job description

• Execute manufacturing processes on the floor under supervision, while rigorously following batch records, standard operating procedures (SOPs), and Current Good Manufacturing Practice (cGMP) regulations to ensure manufacturing operations are safe and compliant.
• Ensure right-the-first-time performance of all process steps specific to the phase or stage of operation, as well as help drive the safety-first culture.
• Work as part of a team to execute Good Manufacturing Practice (GMP) runs in close collaboration with, Manufacturing Science and Technology (MSAT), Facilities and Engineering (F&E) and Quality departments.
• Under supervision, perform weighing of raw materials, as well as electronic inventory transactions utilizing Manufacturing Execution Systems (MES) and Enterprise Business system (EBS).
• Under supervision, perform cell culture and filling unit operations for the manufacturing of viral vector products in a cGMP environment using proper aseptic technique, proper laboratory etiquette, Good Documentation Practices (GDP), and sound scientific methods.
• Prepare and use single use systems to support solution formulation and filter integrity testing.
• Maintain mammalian cell culture in flasks, CellSTACK chambers and single use bioreactor systems.
• Assist with transfection of cells and harvest of viral vectors.
• Assist with manual and/or automated fill of harvested viral vector material.
• Escalate processing and equipment issues as needed.
• Assist with revisions of SOPs, Manufacturing Production Record (MPRs), and other controlled documents.
• Assist in the review of in-process cGMP documentation for completeness, accuracy, and compliance.
• Ability to work effectively in an inclusive, cross-functional, team-based environment.
• Able to work off shift hours and weekend.