Operator I - Utility & RMS

Role Summary

The purpose of the position is to operate utility and RMS process equipment to support API-US production. Responsibilities include operation of applicable equipment within the scope of the department. Other duties will be receiving materials, completing training and supporting quality & financial goals for the site. Establish & maintain positive working relationships with internal & external stakeholders and ensure all activities are aligned 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

• Required: High school graduate or GED
• Preferred: Bachelor’s Degree in a relevant field of study from an accredited university
• BioWork certification or equivalent a plus
• Minimum of 6 months of related experience in regulated industry
• 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; active participation in event response activities; documented problems & rapid resolution & prevention of recurrence preferred
• Basic knowledge of production utility systems or raw material handling (e.g., 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 complex product documentation & SOPs with attention to high-level concepts a plus
• Computer literacy with associated systems
• Proven ability to check results & revise work tasks to meet daily plan preferred

Skills

• Problem solving and data-driven troubleshooting
• Communication and stakeholder collaboration
• Documentation and record-keeping
• Technical reading and interpretation of equipment documents
• Proficiency with automated/process control systems

Education

• High school diploma or GED required
• Bachelor’s degree in a relevant field preferred

Additional Requirements

• Physical requirements: moves equipment or supplies up to 33 pounds, standing for up to 12 hours, potential exposure to hazardous materials, possible use of PPE, and other site-specific requirements