Operator I - Utility & RMS

About This Role

Operate utility and Raw Material Systems (RMS) process equipment to support Active Pharmaceutical Ingredients (API) production, ensuring compliance with cGMP and EHS standards.

Responsibilities

• Operate equipment and processes following Standard Operating Procedures for both nGMP and cGMP 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)
• 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
• 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

Requirements

• High school graduate or GED

Qualifications

• High school graduate or GED required
• Minimum of 6 months of related experience in regulated industry required.

Nice to Have

• Bachelor’s Degree in a relevant field of study
• BioWork certification or equivalent
• Knowledge & experience in the operations and maintenance of utility and raw material systems
• Experience working in a regulated environment (FDA, cGMP, OSHA)
• Experience demonstrating a systematic approach to problem solving & troubleshooting based on data & facts
• Basic knowledge of production utility systems or raw material handling such as: purified water, process air, chemical storage & process waste systems
• Ability to work with electronic batch records, automated process equipment, and/or DeltaV or Syncade
• Ability to read/review equipment documents with a basic understanding
• Understanding of complicated product documentation & standard operating procedures with attention to high-level concepts
• Proven ability to check results & revise work tasks to meet daily plan

Skills

* Required skills

Benefits