Operator I - Utility & RMS

Role Summary

Operator I - Utility & RMS at Novo Nordisk, operating utility and RMS process equipment to support API-US production. Responsibilities include operation of applicable equipment within the scope of the department, receiving materials, completing training, and supporting quality & financial goals for the site. Establish and maintain positive working relationships with internal and external stakeholders and ensure all activities are aligned with Environmental Health & Safety 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 and clearance to minimize downtime and ensure a safe working environment
• Maintain standards and operational procedures for automated and manually operated systems
• Support consistent operation, maintenance and 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 and 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 SOPs and cGMP standards
• Follow all safety and environmental requirements in the performance of duties
• Other accountabilities, as assigned

Qualifications

• High school graduate or GED required
• Bachelor‚Äôs Degree in a relevant field of study from an accredited university preferred
• BioWork certification or equivalent a plus
• Minimum of 6 months of related experience in regulated industry required
• Knowledge and experience in the operations and maintenance of utility and raw material systems, in a regulated environment (FDA, cGMP, OSHA) a plus
• Experience with systematic problem solving and troubleshooting based on data and facts; participated in event response activities; documented problems and worked on rapid resolution and preventing recurrence preferred
• Basic knowledge of production utility systems or raw material handling such as purified water, process air, chemical storage and 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 and SOPs with attention to high-level concepts a plus
• Computer literacy with associated systems required
• Proven ability to check results and revise work tasks to meet daily plan preferred

Education

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

Skills

• Proficiency with operating and maintaining utility and process control systems
• Strong problem-solving and analytical abilities
• Effective communication and stakeholder collaboration
• Attention to compliance with SOPs, cGMP, and safety regulations
• Experience with electronic batch records and automated process equipment