Component Prep Operator - Weekend Shift

Our Need:

The Component Prep Operator will prepare equipment prior to each batch operation in accordance with SOPs and quality controls applicable to that operation, making adjustments 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. He/she/they will also be responsible for completing all documentation related to the status of the equipment associated with each batch and maintain compliance for cleaning requirements.

Your Role:

• Assemble, disassemble, maintain, and sanitize the production operating equipment as necessary.
• Monitor production equipment while in operation to ensure quality of product.
• Ensure that production equipment is safe and that, while in operation, it is run safely by all personnel.
• Complete all necessary documentation regarding the equipment and its operational performance to meet regulatory and cGMP requirements.
• Run Autoclave to sterilize product prior to packaging.
• Work safely in accordance with regulations, standards, and procedures which eliminates unreasonable risk to health and the environment.
• Notify management of unsafe conditions or practices, unlawful activities and activities which present unreasonable health and/or environmental risk.
• Report all safety and/or environmental incidents to management immediately.
• 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.
• Work with groups in initiating and implementation of programs such as continuous improvement (Lean) and autonomous maintenance (TPM).
• Other duties as assigned with or without accommodation.

Your Background:

Education required/ preferred:

• High School diploma, GED, or equivalent required 2 year technical degree preferred

Experience:

• 2-5 years experience as a Production Set-up Operator or mechanic in a pharmaceutical manufacturing environment (preferred).

Preferred Skills/Qualifications:

• 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 trouble shooting skills

Skills/Competencies:

• Basic computer skills – Microsoft Office package
• Ability to lift up to 50 pounds

Other Skills:

• Ability to work well in a team environment