Sterile Production Technician - Evening (1 position)/Night (2 positions)

The sterile production technician performs the manufacturing and filling steps of injectable products, executes the assembly, operation, and disassembly of production equipment, and prepares autoclave and oven loads while following instructions and procedures, within a GMP context.

3 positions to fill

• 1 evening position
• 2 night positions

Tasks and responsibilities

• Inspect and prepare production areas.
• Assemble, adjust, and disassemble equipment used in production.
• Perform tasks described in production folders and complete them appropriately.
• Prepare cleaning solutions, clean equipment and rooms related to production.
• Prepare materials for sterilization and depyrogenation.
• Keep records up to date.
• Perform production tasks from material reception to product filling and capping (weighing ingredients, mixing, filtration, sample taking, filling, capping).
• Collaborate with the supervisor and other department representatives to ensure work is done according to GMP.
• Verify, maintain, and calibrate production equipment.
• Write production-related procedures and follow training.
• Maintain material inventory (filters, tubing, sterile wipes, etc.).
• Execute validation protocols related to injectable products.

Environmental and physical conditions

• Requires wearing personal protective equipment at all times.
• Requires qualification in gowning and simulations with culture medium (media fill).
• Standing work.
• Subject to environmental personnel controls upon entering aseptic areas.
• Participate in investigations when required.
• Work in an aseptic environment.

Skills, knowledge, and abilities

• Excellent knowledge of GMP.
• Experience in the pharmaceutical industry.
• Good knowledge of regulations.
• Good knowledge of sterile manufacturing principles.
• Teamwork ability.
• Good personal hygiene.
• Ability to support gowning in controlled zones at all times.
• Comfortable in a highly regulated environment.
• Ability to fill out documents appropriately according to GMP (in real-time).
• Good communicator and ability to share knowledge during training.
• Concentration ability.
• Adequate physical fitness.
• Ability to work to meet established times according to quality standards in place.

Experience

Mandatory* 5 year(s): 5 years of experience in the pharmaceutical industry or possession of a university diploma.

Education

• Mandatory* High school diploma or better in General - General