Manufacturing Tech III
Gilead Sciences
7 hours ago
On-site
La Verne, CA
Operations
Knowledge & Skills:
- Working knowledge of Standard Operating Procedures (SOPs) and Master Batch Records (MBRs).
- Strong understanding of cGMP requirements and regulated manufacturing environments.
- Good verbal, written, and interpersonal communication skills.
- Proficiency in Microsoft Office applications and familiarity with administrative systems.
- Ability to follow direction while working independently with minimal supervision.
- Demonstrated capability to train and mentor others on manufacturing processes (e.g., filling, hydration, coating, granulation, compression).
- Ability to coordinate and organize complex manufacturing activities.
Key Responsibilities:
- Perform routine to moderately complex manufacturing operations in compliance with SOPs, MBRs, and cGMP standards.
- Execute operations across multiple unit processes, including aseptic processing, dispensing, compaction, granulation, milling, and coating.
- Assemble/disassemble/operate aseptic filling equipment and lyophilizer autoloading systems in classified cleanrooms.
- Prepare equipment/components for sterilization (autoclaves, ovens, vial washers, depyrogenation tunnels).
- Perform CIP/SIP and manual cleaning/assembly; conduct sterile filtration and annealing.
- Operate downstream equipment (e.g., vial cappers); support unloading and packaging.
- Perform Oracle and MES transactions; resolve inventory discrepancies.
- Maintain clean, compliant manufacturing areas; maintain GMP documentation (logbooks, batch records, reports).
- Support MBR updates and batch documentation; dispense raw materials.
- Operate solid dose equipment (drum coaters, compression machines); manual material handling.
- Create purchase orders for consumables; provide updates on line performance/issues/deviations.
- Troubleshoot moderately complex equipment/process issues; may serve as point of contact during compliance audits.
Basic Qualifications:
- High School diploma with 3+ years relevant manufacturing experience.
- FETAC Level 6 (GSL) or equivalent technical certification.
- Prior experience in a cGMP-regulated industry is required.
Shift:
- Night Shift: 4p–4:30a, Sunday/Monday/Tuesday and every other Wednesday.
Application Instructions:
- For current employees/contractors: apply via the Internal Career Opportunities portal in Workday.
- Working knowledge of Standard Operating Procedures (SOPs) and Master Batch Records (MBRs).
- Strong understanding of cGMP requirements and regulated manufacturing environments.
- Good verbal, written, and interpersonal communication skills.
- Proficiency in Microsoft Office applications and familiarity with administrative systems.
- Ability to follow direction while working independently with minimal supervision.
- Demonstrated capability to train and mentor others on manufacturing processes (e.g., filling, hydration, coating, granulation, compression).
- Ability to coordinate and organize complex manufacturing activities.
Key Responsibilities:
- Perform routine to moderately complex manufacturing operations in compliance with SOPs, MBRs, and cGMP standards.
- Execute operations across multiple unit processes, including aseptic processing, dispensing, compaction, granulation, milling, and coating.
- Assemble/disassemble/operate aseptic filling equipment and lyophilizer autoloading systems in classified cleanrooms.
- Prepare equipment/components for sterilization (autoclaves, ovens, vial washers, depyrogenation tunnels).
- Perform CIP/SIP and manual cleaning/assembly; conduct sterile filtration and annealing.
- Operate downstream equipment (e.g., vial cappers); support unloading and packaging.
- Perform Oracle and MES transactions; resolve inventory discrepancies.
- Maintain clean, compliant manufacturing areas; maintain GMP documentation (logbooks, batch records, reports).
- Support MBR updates and batch documentation; dispense raw materials.
- Operate solid dose equipment (drum coaters, compression machines); manual material handling.
- Create purchase orders for consumables; provide updates on line performance/issues/deviations.
- Troubleshoot moderately complex equipment/process issues; may serve as point of contact during compliance audits.
Basic Qualifications:
- High School diploma with 3+ years relevant manufacturing experience.
- FETAC Level 6 (GSL) or equivalent technical certification.
- Prior experience in a cGMP-regulated industry is required.
Shift:
- Night Shift: 4p–4:30a, Sunday/Monday/Tuesday and every other Wednesday.
Application Instructions:
- For current employees/contractors: apply via the Internal Career Opportunities portal in Workday.