Manufacturing Tech III

Job Description

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