Manufacturing Tech III

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, and operate aseptic filling equipment and lyophilizer autoloading systems in classified cleanroom environments.
• Prepare equipment and components for sterilization, including operation of:
  • Autoclaves
  • Ovens
  • Vial washers
  • Depyrogenation tunnels
• Perform clean-in-place (CIP) and sterilization-in-place (SIP) of tanks and equipment, as well as manual cleaning and assembly.
• Conduct sterile filtration and annealing processes.
• Operate downstream equipment, including vial cappers, and support unloading and packaging of product from lyophilizers and fill lines.
• Perform Oracle and MES transactions to support production and resolve inventory discrepancies.
• Maintain manufacturing areas in a clean and compliant state, including walls, ceilings, and floors.
• Complete and maintain accurate GMP documentation, including logbooks, batch records, and reports.
• Support MBR updates and batch documentation activities.
• Dispense raw materials and manage batch preparation activities.
• Operate solid dose equipment, including drum coaters and compression machines.
• Perform manual material handling, including loading/unloading of tablets and product.
• Create purchase orders for consumables as needed.
• Provide regular updates to the Team Lead on line performance, issues, and deviations.
• Perform independent troubleshooting of moderately complex equipment and process issues.
• May serve as a point of contact during compliance audits.

Basic Qualifications:

• High School diploma with 3+ years of relevant manufacturing experience.
• FETAC Level 6 (GSL) Certificate 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