Manufacturing Associate I

The Position

Operate API manufacturing equipment to achieve production goals.

Relationships

Shift Manager, Operations - API.

Essential Functions

• Work in a safe & environmentally responsible manner
• Follow instructions listed in GMP documentation & product quality
• Review SOP’s & other documents, as required
• Real time review of electronic batch records ensuring compliance to Standard Operating Procedures (SOPs) & current Good Manufacturing Practices (cGMP) standards
• Manage individual training plan
• Participate in qualification & validation activities as required
• Setup, operate, monitor, & control highly automated processes & systems
• Load & unload product from trucks, tankers & ISO containers, as required
• Execute production schedule to achieve production goals
• Utilize investigation skills during troubleshooting & assist during equipment maintenance, including restoration of lost function, predictive & preventative maintenance
• Maintain clean room areas & perform environmental monitoring, as required
• Other accountabilities, as assigned
  
  

Physical Requirements

Moves equipment &/or supplies weighing up to 33 pounds within the facility using various body positions. Routinely operates & inspects manufacturing equipment using hands. Strap & unstrap pallets using hands. Must be able to be on your feet for up to a 12-hour shift. May require corrected vision to 20/20 or 20/25 based on role. May require color vision based on role. Occasionally ascends/descends a ladder. May be required to work at elevated heights. Occasionally works around odorous &/or hazardous materials. May be required to wear latex gloves. May perform critical job functions in extremely cold work environments depending on site. May position oneself within confined spaces for inspection if required of the role. Ability to work in loud noise environments with hearing protection. May be required to secure a motorized vehicle license & operate a motorized vehicle based on the role.

Qualifications

• High school graduate or equivalent required
• Associate’s degree or higher in Tech, Science, or Engineering preferred
• BioWork or equivalent industrial, military or vocational training combined with experience preferred
• Minimum two (2) years of manufacturing experience in FDA regulated environment preferred
• Experience demonstrating a systematic approach to problem solving & troubleshooting based on data & facts. Actively participated in & driven event response activities. Documented problems & worked on ensuring rapid resolution & preventing recurrence preferred
• Experience following SOPs to perform tasks & raising issues if errors are found preferred
• Experience following established safety guidelines when performing tasks preferred
• Computer literacy including, but not limited to, ability to operate computer driven manufacturing/production equipment & efficient use of Microsoft Office suite programs required
• Ability to read & understand complicated product documentation & standard operating procedures with attention to detail required
• Ability to perform basic material handling tasks, safely & effectively use material handling equipment required
• Ensure compliance with corporate/local SOPs, regulations & ISO standards required
• General knowledge in cGMP manufacturing & production processes associated with pharmaceutical companies required
• Basic knowledge of biology/chemistry preferred
• Mechanical aptitude, ability to follow use tools to perform tasks, basic troubleshooting of mechanical components & systems preferred
• Experience working with work permits/Lock Out Tag Out systems preferred
  
  

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