Pharma API Manufacturing Operator I

BioSpace; Clayton (NC); On-site; USD 42,000 - 62,000; Full time

Benefits offered by this job

Paid holidays (14)

Health/Dental/Vision insurance fromDay

401K with company match

Parental & family leave

Tuition assistance

Life & Disability Insurance

Employee referrals

Job summary

Novo Nordisk NC Clayton site seeks a Process Technician to operate utility and RMS equipment supporting API-US production. You will receive materials, complete training, and help meet quality and safety goals while maintaining relationships with internal and external stakeholders.

The role requires a high school diploma or GED, Bachelor's degree preferred, BioWork certification a plus, and at least 6 months of regulated-industry experience.

Qualifications

• High school graduate or GED required.
• Bachelor's 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 & 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

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 SOPs & cGMP standards
• Follow all safety & environmental requirements in the performance of duties
• Other accountabilities, as assigned

Education

High school diploma or GED

Bachelor's degree in a relevant field

BioWork certification or equivalent

Experience in regulated industry

Job description

Novo Nordisk NC Clayton site seeks a Process Technician to operate utility and RMS equipment supporting API-US production. You will receive materials, complete training, and help meet quality and safety goals while maintaining relationships with internal and external stakeholders.

The role requires a high school diploma or GED, Bachelor's degree preferred, BioWork certification a plus, and at least 6 months of regulated-industry experience.