Job Description

Posted 4 months ago

The Manufacturing Technician I is accountable for results in a fast-paced environment and assists with the manufacturing of drug products (parenteral or solid dosage) for commercial distribution and clinical trials. The Manufacturing Technician I assists with the operation of manufacturing processing equipment by following standard operating procedures (SOPs) and batch records in accordance with regulatory agencies and current Good Manufacturing Practices (cGMPs).  The Manufacturing Technician I employs acceptable techniques while working in manufacturing environments, including PPE gowning.  The Manufacturing Technician I works collaboratively to support other manufacturing areas as required. The position requires superior leadership behaviors of the Alcami core competencies and non-negotiables, as well as expertise in functional competencies for the role.

Essential Functions

• Follows applicable SOPs and cGMPs to perform assigned duties and tasks.
• Ensures timely completion and compliance with cGMP and all other relevant company training requirements.
• Assists with applicable manufacturing techniques and technologies per SOPs and cGMPs.
• Assists with manufacturing technologies and operation of manufacturing and material handling equipment.
• Documents activities in real time on controlled documentation and legibly, per SOPs and cGMPs.
• Performs in-process testing, weight checks, component counting and basic math calculations.
• Performs cleaning of rooms, tools and equipment.
• Assists with other manufacturing areas as required.

Manufacturing Technologies for Sterile Liquids:

• Equipment and component preparation and sterilization
• Compounding
• Aseptic filling
• Capping

Education and Experience

• High school diploma or GED required.  Associate’s degree preferred.
• Entry level, 0-1 years of work experience required; 1-2 years of relevant experience preferred.
• cGMP or prior work experience in a regulated environment preferred.
• Prior pharmaceutical or CDMO experience preferred.