Operator I - Utility & RMS

Novo Nordisk • Clayton, NC

35d

About The Position

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.

Requirements

• High school graduate or GED required
• Minimum of 6 months of related experience in regulated industry required
• Computer literacy with associated systems required
• Proven ability to check results & revise work tasks to meet daily plan preferred

Nice To Haves

• Bachelor's Degree in a relevant field of study from an accredited university preferred
• BioWork certification or equivalent a plus
• 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

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

Benefits

• Leading pay and annual performance bonus for all positions
• All employees enjoy generous paid time off including 14 paid holidays
• Health Insurance, Dental Insurance, Vision Insurance - effective day one
• Guaranteed 8% 401K contribution plus individual company match option
• Family Focused Benefits including 14 weeks paid parental & 6 weeks paid family medical leave
• Free access to Novo Nordisk-marketed pharmaceutical products
• Tuition Assistance
• Life & Disability Insurance
• Employee Referral Awards

What This Job Offers

• Job Type: Full-time
• Career Level: Entry Level
• Industry: Ambulatory Health Care Services
• Education Level: High school or GED
• Number of Employees: 5,001-10,000 employees