Job Details

1. Purpose and Scope of Position

The Operator I is responsible for executing production activities required to successfully manufacture sterile injectable products. This is accomplished by ensuring equipment, materials, and other resources are in place to meet production demands. The Operator I demonstrates and assures production activities within manufacturing operations are executed following all GMP's. In addition, work will be performed in complete accordance with all SOPs, Specifications, Batch Records, regulatory expectations, and company policies. This position will require overtime, shift work, and flexibility in scheduling of "set" shift hours at times, based on production demands or extraordinary circumstances.

2. Required Competencies: Knowledge, Skills, and Abilities
• Robust functionality in Microsoft Applications and other computer based systems utilized in the manufacturing department (i.e. MES, HMI's, etc.).
• Demonstrated proficiency in the ability to gown into applicable controlled areas per area classification specific requirements.
• Intermediate written and verbal communication skills within the department and with support groups.
• Functional job specific proficiency in mathematics
• Practical understanding of specialized manufacturing equipment operational theory used for the manufacturing of sterile injectable products.
• Ability to pass a full physical including a respiratory certification with annual monitoring.
• Ability to stand up to 8 hrs/day, utilizing controlled movements.
• Aptitude to use hand tools in the setup and trouble-shooting of specialized manufacturing equipment.
• Ability to execute complex activities both independently and in a team environment.

3. Duties and Responsibilities
• Accomplishes manufacturing activities per detailed procedural guidance with a demonstrated attention to detail.
• Performs handling of hazardous materials in compliance with site, industry, local, and federal regulations.
• Maintains manufacturing environmental conditions (Non-Viable Particulate(s) and Viable microbial levels per controlled area classification specifications) by performing area disinfection regiment as required to meet global Health Authority requirements.
• Executes specialized responsibilities mandated by detailed written procedures, site, industry, local, and federal regulations.
• Assures and completes detailed documentation that is a correct and accurate record. Addresses procedural /documentation errors expeditiously and effectively.
• Continuously updates job knowledge by participating in job specialized training requirements.
• Participates as a contributing member in CI projects.
• Consistently projects a positive attitude and example for other department team members/operators to emulate.
• Performs other tasks as assigned.

4. Education and Experience
• High school diploma or equivalent required.
• 1 year of relevant work experience required, preferably in a regulated and/or pharmaceutical environment.
• An equivalent combination of education/experience may substitute.

5. Working Conditions
• Full face respirator may be required for certain activities.
• The incumbent will be required to push, pull, reach, balance, and/or lift greater than 20 lbs. for 8 hours, approximately 5 times per week.
• The incumbent may be working around hazardous materials to include chemical agents at least 8 hours per day.
• The incumbent may be in a standing position for at least 8 hours per day.

Additional Job Requirements:

Position Handles Hazardous Materials