Operator I - Utility & RMS

Role Summary

The purpose of this role is to operate utility and RMS process equipment to support API-US production. Responsibilities include operating applicable equipment within the department's scope. Additional duties include receiving materials, completing training, and supporting quality and financial goals for the site. The role requires establishing positive working relationships with internal and external stakeholders and aligning activities with Environmental Health & Safety (EHS) program expectations.

Responsibilities

• Operate equipment and processes following Standard Operating Procedures for both nGMP and GMP systems
• Identify and document system or operational anomalies for cause & clearance to minimize downtime and ensure a safe working environment
• Maintain standards & operational procedures for automated and manually operated systems
• Support consistent operation, maintenance & response for all control systems (BMS, PCS, Life Safety)
• Support stakeholders as required for successful plant operations including maintenance and optimization activities
• Execute raw material movement and offload into process systems
• Execute site rounds and equipment inspections independently to ensure efficient and compliant operations
• Adhere to all Quality & Environmental regulations
• Participate in systematic problem-solving efforts
• Manage individual training plan
• Perform routine cleaning and good housekeeping as needed for assigned areas
• Review electronic batch records real-time to ensure compliance to Standard Operating Procedures (SOPs) & current Good Manufacturing Practices (cGMP) standards
• Follow all safety & environmental requirements in the performance of duties
• Other accountabilities, as assigned

Qualifications

• BioWork certification or equivalent a plus
• Minimum of 6 months of related experience in regulated industry required
• Knowledge & experience in the operations and maintenance of utility and raw material systems, as well as working in a regulated environment (FDA, cGMP, OSHA) a plus
• 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
• Basic knowledge of production utility systems or raw material handling such as: purified water, process air, chemical storage & process waste systems preferred
• Ability to work with electronic batch records, automated process equipment, and/or DeltaV or Syncade preferred
• Ability to read/review equipment documents with a basic understanding preferred
• Understanding of complicated product documentation & standard operating procedures with attention to high-level concepts a plus
• Computer literacy with associated systems required
• Proven ability to check results & revise work tasks to meet daily plan preferred

Education

• High school graduate or GED required
• Bachelor’s Degree in a relevant field of study from an accredited university preferred

Additional Requirements

• Moves equipment and/or supplies weighing up to 33 pounds within the facility using various body positions
• Routinely operates and inspects manufacturing equipment using hands; strap and 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 and/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 and operate a motorized vehicle based on the role