Production Technician

Mid-Level Aseptic Filling Position

This is a mid-level position in the aseptic filling group within the manufacturing department. It utilizes those with experience and the training needed to manufacture pharmaceuticals in a strictly controlled GMP environment. The employee will progress through a number of job functions and be required to demonstrate increasing skill levels while demonstrating leadership capabilities.

Major Position Activities & Responsibilities:

• Become certified for entry into the GMP cleanroom space to be able to perform sanitization, stock/replenish supplies, equipment setup, and all related aseptic filling operations.
• Execute aseptic fill processes using batch records and SOPs.
• Responsible for verifying the calibration of all related equipment and sanitization of supplies to support production.
• Increasing level of competency in the manufacturing area procedures. Assigned job duties will include aseptic and clean room areas, component preparation, filling and capping.
• Learn the functions necessary to work in the fill suite. This will include the operation of the associated equipment.
• Ability to perform tasks with minimal supervisor direction.
• Provide training for new team members.
• Able to understand the manufacturing schedule and coordinate tasks to achieve the schedule.
• Provide floor leadership in the absence of a supervisor or PT3 technicians.
• Transport and/or dispose of hazardous chemicals.
• Perform all other duties as assigned.
• Must immediately notify supervisor if affected by an infectious disease or open lesions on the body, as individuals are not permitted to enter manufacturing areas or handle products if these conditions exist.

Scope:

This position has no direct reports.

Background Qualifications:

• High school diploma or the equivalent. College coursework preferred.
• Minimum 3-5 years, including relevant aseptic filling experience in a cGMP pharmaceutical manufacturing facility.
• Must possess working knowledge and understanding of GMP compliance regulations.
• Must possess knowledge and experience in the aseptic filling process, along with equipment cleaning, preparation, and assembly. Experience in stopper prep, capping, and packaging preferred.
• As persons in this role are engaged in the open manufacture of medicinal products, individuals must not be affected by an infectious disease nor have open lesions on any exposed surface of the body.
• Must be able to comprehend and follow detailed procedural instructions in written and verbal form.
• Must possess adequate working knowledge of arithmetic functions to accurately perform or check calculations required in the product documentation.
• While performing the duties of this job, the employee is regularly required to use their hands and arms. The employee is frequently required to stand. The employee is occasionally required to sit, walk, stoop, kneel, bend, crouch, or crawl, talk or hear. The employee must regularly lift and/or move up to 10 pounds, and frequently lift and/or move up to 50 pounds. Specific vision abilities required by this job include close vision, distance vision, color vision, and peripheral vision.
• Must possess fluent English (written and verbal) skills in order to read, comprehend, and communicate GMP compliance documentation as well as Standard Operating Procedures.
• Computer skills in Microsoft Office, such as Word and Excel are a plus.