API Manufacturing Operator I

Biopharma Careers; Iowa (LA); On-site; USD 42,000 - 64,000; Full time

Benefits offered by this job

Annual bonus

Paid holidays

Health insurance

Dental insurance

Vision insurance

401k match

Parental leave

Life & disability insurance

Referral rewards

Tuition assistance

Job summary

Novo Nordisk is hiring for an API manufacturing operator to support production goals in a stringent GMP environment. You will operate highly automated processes, review batch records, and ensure compliance with SOPs and cGMP.

Training plans and qualification activities are part of the role, with opportunities for professional growth. The position requires a high school diploma and preferred advanced tech/science training; FDA-regulated manufacturing experience is a plus.

Qualifications

• High school graduate or equivalent.
• Associate's Degree or higher in Tech, Science, or Engineering preferred.
• BioWork or equivalent industrial/military/vocational training ongoing preferred.
• Minimum two years of manufacturing experience in FDA-regulated environment preferred.
• Experience solving problems with data-driven approach; event response experience preferred.
• Experience following SOPs and safety guidelines; ISO standards familiarity preferred.
• Computer literacy and ability to operate computer-driven equipment; MS Office proficiency.
• Ability to read complex product documents and SOPs with attention to detail.

Responsibilities

• Operate API manufacturing equipment to achieve production goals.
• Follow GMP documentation and product quality requirements.
• Review SOPs and other documents as required.
• Real-time review of electronic batch records for compliance with SOPs and cGMP.
• Manage training plans for individuals.
• Participate in qualification and validation activities as required.
• Setup, operate, monitor, and control highly automated processes and systems.
• Load and unload product from trucks and ISO containers, as required.
• Execute production schedules to meet production goals.

Skills

High school graduate

Tech/Science/Engineering degree

BioWork training

2+ years manufacturing

Problem solving

SOP compliance

Office skills

Documentation literacy

Material handling

SOP & ISO

cGMP knowledge

Biology/Chemistry basics

Mechanical aptitude

LOTO experience

Education

High school diploma or equivalent

Associate's Degree or higher in Tech/Science/Engineering

BioWork or equivalent industrial training

Tools

Microsoft Office

Job description

Novo Nordisk is hiring for an API manufacturing operator to support production goals in a stringent GMP environment. You will operate highly automated processes, review batch records, and ensure compliance with SOPs and cGMP.

Training plans and qualification activities are part of the role, with opportunities for professional growth. The position requires a high school diploma and preferred advanced tech/science training; FDA-regulated manufacturing experience is a plus.