Aseptic Manufacturing Technician is responsible for conducting daily production activities within the Parenteral Facility and supporting work centers in accordance with FDA, EU and JP Good Manufacturing Practices (GMP). This position will participate in the manufacturing of sterile parenteral dosage forms and will be responsible for ensuring exceptional quality standards in accordance with Eisai’s human health care (hhc) mission. The Aseptic Manufacturing Technician will participate within a specialized, self-directed work team and will possess proficiency in all production unit operations to include drug formulation, fill-finish operations, visual inspection and secondary packaging.
1. Fill-Finish Operations – Set up and operate the filling line with minimum down time and interventions to produce finished dosage forms that meet the safety, identity, strength, quality and purity attributes. Conduct activities following proper aseptic procedures in accordance with SOPs and batch record instructions. Perform all staging, set-up, cleaning, sanitizing and decontamination activities to support the fill-finish operations. 30%
2. Visual Inspection - Perform 100% visual inspection of bright stock vials. Perform cleaning / clearance, staging, set-up and batch reconciliation activities to support the inspection operations. Record, categorize and trend inspection rejects to comply with GMP quality control monitoring requirements. 20%
3. Secondary Packaging – Set up and operate the packaging line with minimum down time and interventions. Perform all cleaning, line clearance, staging, set-up and batch reconciliation activities to support the packaging operations. Record, categorize and trend packaging rejects to comply with GMP quality control monitoring requirements. 20% 4. Drug Formulation – Formulate and sterile filter drug product in accordance with the Master Batch Record and high-hazard substance containment practices. Perform staging, cleaning, set-up, API handling, and decontamination activities to support formulation operations. 15%
5. Documentation - Document all production and maintenance activities on the master batch record or ParCS to comply with GMP requirements. Assist with manufacturing deviation analysis, CAPA actions and other process equipment related quality concerns. May create, revise, and review Standard Operating Procedures (SOP) and Master Batch Records as necessary to support Parenteral Operations.
High School Diploma required and Associate’s Degree is desirable.
Pharmaceutical manufacturing experience required and parenteral manufacturing experience is desirable. An understanding and working knowledge of pharmaceutical / parenteral manufacturing technologies including aseptic manufacturing techniques.
Documentation activities require computer competency.
Knowledge of microbiological principles is desirable.
Requires the lifting of heavy objects (up to 50 lbs) and pulling heavy objects (? 50 lbs) using a pallet jack.
Ability to work/lift using isolator glove ports. Limited access via glove ports causes fatigue and severely restricts movement.
Requires the ability to work with hazardous materials with strong personal safety awareness.
Requires the ability to stand for prolonged periods (? 4 hours) and egress from the filling suite is time consuming, therefore breaks are held to a minimum.
Ability to operate pH meters, balances, computerized automation systems, and plant utilities services such as compressed process air, compressed nitrogen and Water-for-Injection (WFI).
Requires strong communication, teamwork and collaboration.
Professional attitude and detail orientation.
Must have 20-20 vision (vision correction lenses acceptable).
HOURS: MON-FRI 7am-3:30pm with OT. OT on weekends as well.
MUST HAVE ASEPTIC EXPERIENCE
PARENTARAL EXP OR TRADITIONAL EXP
Must be flexible and a team player.
The Greer Group, Inc. - 10 months ago