Aseptic Production Operator II: Parenteral Manufacturing

Indivior

Raleigh (NC)

On-site

USD 28,000 - 34,000

Full time

10 days ago

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Benefits offered by this job

Bonus program
Long-Term Incentive Plan
PTO + company closure end year
401(k) matching
Employee Stock Purchase Plan 15%
Medical, Dental, Vision, Life and Disb
Tuition reimbursement
Wellness programs

Job summary

Indivior is seeking an Operator II, Aseptic Production to operate processing and test equipment in aseptic areas, adhering to cGMP and SOPs to produce parenteral products. The role emphasizes training, data review, equipment sanitation, and meticulous documentation across production systems.

The position requires a High School Diploma and at least one year in a regulated environment, with strong attention to detail and communication skills essential for collaboration with QA, maintenance, and

Qualifications

  • High School Diploma required.
  • Minimum one year experience in a regulated environment.
  • Gowning experience in a classified area is required.
  • Knowledge of cGMPs.
  • Basic math and science skills and ability to use a computer.
  • Demonstrated ability to read, understand, interpret, and apply technical writing and instruction.
  • Strong communication skills (verbal and written).
  • Attention to detail.
  • Experience with batch records handling and understanding of pharmaceutical production.
  • Mechanical aptitude preferred.

Responsibilities

  • Complies with cGMP through SOPs and policies to produce parenteral products.
  • Ensure training remains compliant before production activities.
  • Equipment cleaning and maintenance; sanitize production areas.
  • Review raw cycle data to ensure process standards are met.
  • Exercise judgment and attention to detail to prevent issues with equipment/product.
  • Communicate with Production, QA, QC, Maintenance and Engineering about operations.
  • Monitor manufacturing cycles; document batch records and logbooks.
  • Maintain a safe work environment; report hazards immediately.
  • Clean, set up, and adjust equipment for proper operation; disassemble and reinstall equipment as needed.
  • Receive, check, store and deliver bulk and finished drug products as directed.
  • Follow established SOPs and document procedures.
  • Perform additional duties as assigned.

Skills

Attention to detail
Strong communication skills
Reading and interpreting technical wrt
Basic math and science
Computer literacy
Gowning experience

Education

High School Diploma

Job description

Indivior is seeking an Operator II, Aseptic Production to operate processing and test equipment in aseptic areas, adhering to cGMP and SOPs to produce parenteral products. The role emphasizes training, data review, equipment sanitation, and meticulous documentation across production systems.

The position requires a High School Diploma and at least one year in a regulated environment, with strong attention to detail and communication skills essential for collaboration with QA, maintenance, and

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