Filling Setup Operator - 1st Shift  (28305)

WHAT WE'RE LOOKING FOR:

The Filling Setup Operator will prepare the equipment prior to each batch operation according to SOPs and quality controls, adjusting for size and/or product as necessary. He/she/they will monitor the equipment during each batch operation to ensure that quality and safety are maintained throughout the operation. The operator will also complete documentation concerning the status of the equipment during each batch maintain compliance for all cleaning requirements. This position is Monday-Thursday from 5:00am - 3:30pm. 

YOUR ROLE:

• Assemble, disassemble, maintain, and sanitize the production operating equipment as necessary.
• Process components (wash, extract, rinse, and siliconize).
• Monitor production equipment to ensure quality of product and safety of personnel.
• Complete necessary equipment documentation to meet regulatory and cGMP requirements.
• Operate an autoclave to sterilize product prior to packaging.
• Operate in an ISO5 or lower classified area
• Work safely in accordance with regulations, standards, and procedures and in a manner that eliminates unreasonable risk to health and the environment.  
• Assist team leader in coordinating maintenance activities.
• Prevent excess waste of product and/or components by operating the equipment in an efficient manner.
• Maintain production schedules.
• Initiate and implement programs such as continuous improvement (Lean) and autonomous maintenance (TPM) in a team of 10-12 operators. 
• Other duties as assigned with or without accommodation.

YOUR BACKGROUND:

• High School diploma, GED, or equivalent required
• 2-year technical degree (preferred)
• 2-5 years as a set-up operator or mechanic in a pharmaceutical environment (preferred)
• Good verbal and interpersonal communication skills
• Basic knowledge and use of hand tools
• Sound decision making skills
• Good math, reading, writing skills
• Demonstrated mechanical aptitude
• Mental and visual acuity for production of quality product
• Strong troubleshooting skills
• Basic computer skills – Microsoft Office package
• Ability to lift up to 50 pounds
   

WHAT TO EXPECT:

• Standing is required for extended periods of time.
• Requires high degree of manual dexterity which could be performed under restrictive conditions.
• Requires flexible hours and short notice overtime.
• Work in areas where special clean room apparel and safety equipment will be required.