GMP Manufacturing Operator II

Job Requirements

Title: GMP Manufacturing Operator II

Employer: Aventira Pharmaceuticals

Location: Los Angeles, CA — on-site

Function / Dept: Manufacturing / Operations — Sterile Injectables

Shift: Multiple openings across day and swing shifts; rotating weekend coverage as scheduled

Employment type: Full-time, non-exempt

About the role

At Aventira, the medicines we make reach millions of patients across more than 100 countries — and every one of them starts on a manufacturing floor like ours in Los Angeles. As a GMP Manufacturing Operator II, you'll execute cGMP production — compounding, filling, and inspection of sterile injectables — inside our ISO-classified cleanrooms, working from electronic batch records on a modern digital shop floor. This is precise, right-first-time work where data integrity and discipline protect patients, and where a global career ladder is open to you.

What you'll do

• Execute manufacturing operations per approved SOPs, electronic batch records, and current Good Manufacturing Practices (cGMP / 21 CFR 211).
• Gown and maintain aseptic technique in ISO-classified cleanrooms in line with EU GMP Annex 1 sterile-manufacturing expectations.
• Perform line clearance, equipment setup, in-process checks, and sampling; operate and monitor automated process equipment during runs.
• Record all activity with accurate, contemporaneous, right-first-time documentation that meets ALCOA+ data-integrity standards.
• Support cleaning, sanitization, and environmental monitoring of the manufacturing suite.
• Identify, document, and escalate deviations; support investigations, CAPA, and change control.
• Maintain gowning qualification and complete ongoing GMP and role-specific training.
• Contribute to continuous-improvement, safety (EHS), and operational-excellence initiatives on the floor.

Work Experience

What you'll bring (required)

• High school diploma or GED (Associate's degree or technical certificate a plus).
• 2–4 years of experience in a cGMP-regulated manufacturing environment (pharma, biotech, or medical device).
• Demonstrated ability to gown and work in aseptic / cleanroom conditions for a full shift.
• Proven adherence to SOPs, batch records, and manufacturing instructions with a strong data-integrity mindset.
• Meticulous documentation accuracy and attention to detail.
• Able to lift/push/pull up to 25–50 lbs and stand for 6–8 hours in a production suite.
• Willingness to work assigned shift, including rotating weekend coverage.

Nice to have (preferred)

• Aseptic fill-finish experience in a commercial pharma setting.
• Hands-on experience with MES / electronic batch records (e.g., PAS-X, Syncade) and automation (e.g., DeltaV).
• Familiarity with EU GMP Annex 1 (2022) and contamination-control strategy.
• Exposure to deviation / CAPA, change control, and environmental-monitoring programs.

Benefits

Why Aventira

• A global career ladder and tuition/certification support (aseptic processing, Six Sigma).
• Comprehensive medical, dental, vision, 401(k) match, and shift differential.
• A mission that touches millions of patients — and a site culture built on safety and quality.