Utility Operator II - 1st Shift

JOB PUPOSE

Set ups, adjusts, maintains and operates various pieces of equipment, i.e. automatic glass washers, depyrogenation tunnels, cappers, tray loaders and automatic bag openers while complying with GMP regulations as well as internal SOPs. Utility Operator II also provides support to Group Leader, Manufacturing as may be required and serves in a Group Leader-Manufacturing capacity when required. This position has leadership responsibilities. Training others is a requirement of this job.

 

KEY ACCOUNTABILITIES 

• Regular and predictable onsite attendance and punctuality.
• Prepares equipment at start of lot. 
• Verifies incoming components for correctness using Order Number.
• Set up and operates equipment throughout shift.
• Monitors parameters i.e., machine speed, water pressure, temperature, belt speed, etc. periodically during the shift and records as required per SOPs and cGMPs.
• Clean and clears equipment and work area at the beginning and end of each production run.
• Report manufacturing/component deviations; including, but not limited to, visually defective glassware or components to the area Process Supervisor or designee.Report machine/process deviations to area Process Supervisor or designee.
• Completes and maintains all required batch record and logbook paperwork.
• Maintains general housekeeping of equipment and area throughout shift.
• Works overtime as required to support business needs.
• While performing the duties of this job, the employee is required to stand 100% of the time.  The employee maybe required to lift 5–40 lbs continually throughout the workday.  This job involves frequent bending, twisting, pushing, pulling, and lifting.
• Performs training related to production.
• Independently perform manufacturing Group Leader duties when/as required.
• Sets up catching windows to support the manufacturing process.
• Performs other related duties as determined by management personnel.

 

QUALIFICATIONS

Minimum:    High school diploma or equivalent

 

EXPERIENCE

 

Minimum:    Two years job experience as a Utility Operator

 

SKILLS

• Ability to read and interpret documents such as safety rules, operating and maintenance instructions and procedure manuals. Ability to write routine reports and correspondence
• Able to perform mathematical calculations associated with production documentation analysis and problem solving

• Technically oriented with ability to analyze production related problems and suggest solutions.
• Good close visual acuity (eye exam required)

• The noise level on the production lines is usually moderate to loud; appropriate PPE required as posted in each area

• Excellent interpersonal and leadership skills with ability to interface well with other departments and lead effectively and efficiently in a team environment
• Ability to manage multiple priorities in a manufacturing plant setting
• Strong writing skills and ability to complete batch records and prepare Event Report Forms
• Ability to understand GMPs and other regulatory guidelines applicable to the pharmaceutical industry
• Strong assessment and troubleshooting skills
• Ability to use computer systems such as SAP
• Requires good analytical skills and familiarity with quality control procedures and basic manufacturing calculations

 

What We Offer

• Clean climat