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Associate, Manufacturing (Small Scale Filling)

CSL

Holly Springs, NCOnsitePosted 23 days ago
Full TimeEntry LevelManufacturing & CMCBiotechnology
Original posting ↗

Summary

Reporting to the area Manager, you will work onsite on the shop floor employee in manufacturing operations. You will provide (train in) the technical skill-sets necessary to manufacture high quality biologicals safely in a compliant, efficient, and cost-effective manner.

Job description

  • Shift: Day
  • Hours: 8-5pm
  • Follow M-F schedule
  • Job level will be determined based on years of relevant experience to our processes and equipment

Responsibilities

  • Become trained on basic processes and equipment and serves as a hands-on resource in Production.
  • Conduct all assigned activities in a safe and cGMP compliant manner.
  • Clean, prepare, and sterilize production equipment and disinfect production rooms.
  • Assembly, set-up, and disassembly of production equipment.
  • Execute process steps according to defined SOPs and BPRs.
  • Document activities following cGMPs.
  • Handle biologically and chemically hazardous good.
  • Interface with process automation systems and electronic business systems (e.g, PAS, BAS, PLCs, LIMS, SAP, LiveLink.)
  • Involved in Qualification and Validation activities.
  • Involved in completion of root cause investigations and CAPA implementation.

Qualifications

  • High school diploma/GED required, with training and education from biotechnology coursework being a plus;
  • Minimum of 2 years of transferrable skills and experience OR equivalent education, coursework or hands-on training in biomanufacturing related areas; experience in pharmaceutical, biotechnology, or sterile production environments.
  • Basic knowledge of cGMP requirements preferred
  • Experience completing SOPs and documenting work
  • Basic mechanical aptitude or knowledge of electronic / mechanical equipment preferred.

Requirements

  • High school diploma/GED required
  • Minimum of 2 years of transferrable skills and experience OR equivalent education, coursework or hands-on training in biomanufacturing related areas
  • Experience in pharmaceutical, biotechnology, or sterile production environments
  • Experience completing SOPs and documenting work
  • Basic knowledge of cGMP requirements preferred
  • Basic mechanical aptitude or knowledge of electronic / mechanical equipment preferred
  • Training and education from biotechnology coursework being a plus

Benefits

  • Onsite Café
  • Walking Trail
  • Basketball Court
  • Tennis Court
  • Medical Insurance
  • Dental Insurance
  • Vision Insurance
  • Life Insurance
  • 401(k) Matching
  • Annual Bonus
  • Paid Time Off
  • Wellness Days
  • Floating Holidays

Company overview

CSL Limited is an Australian multinational specialty biotechnology company that researches, develops, manufactures, and markets products to treat and prevent serious human medical conditions. Founded in 1916 as Commonwealth Serum Laboratories, CSL has grown to become the world's fifth largest biotechnology company with operations in over 35 countries. The company specializes in blood plasma derivatives, vaccines, antivenoms, and cell culture reagents used in medical and genetic research applications. CSL operates through several key divisions including CSL Behring (focusing on rare and serious diseases), CSL Seqirus (one of the world's largest influenza vaccine providers), CSL Plasma, and CSL Vifor. With over 32,000 employees globally, CSL maintains a strong R&D pipeline and has invested over US$3.3 billion in research and development over the past five years. The company is publicly traded on the Australian Securities Exchange and has its global headquarters in Parkville, Melbourne, Australia.

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