Associate I, Manufacturing

CSL Vifor; Holly Springs (NC); On-site; USD 42,000 - 54,000; Full time

Job summary

CSL Vifor in Holly Springs, NC is seeking a dedicated shop floor operator for the night shift to manufacture high-quality biologics in a compliant, cost-effective manner. You will be trained on basic processes and equipment, performing sterile production tasks and supporting QA activities in a fast-paced biotech environment.

Responsibilities include cleaning, assembling, setting up and disassembly of equipment, following SOPs/BPRs, documenting activities, and interfacing with process automation

Qualifications

• High school diploma or GED or associate’s degree with 1+ years’ transferable skills, or bachelor’s with 0+ years’ experience, or equivalent.
• Experience in pharmaceutical/biotech/sterile production environments preferred.
• Basic knowledge of cGMP requirements preferred.
• Experience executing SOPs and documenting work preferred.

Responsibilities

• Becomes trained on basic processes and equipment and serves as a hands-on resource in Production.
• Conducts all assigned activities in a safe and cGMP compliant manner. Tasks include cleaning, preparing, and sterilizing production equipment; disinfecting rooms; assembly and disassembly of equipment; executing process steps per SOPs/BPRs; documenting activities; handling hazardous materials.
• Interface with process automation systems and electronic business systems (e.g., PAS, BAS, PLCs, LIMS, SAP)
• Support Qualification and Validation activities and document issues; assist CAPA investigations.
• Support team effort in root cause investigations and maintain a high-performance teamwork environment.

Skills

Mechanical aptitude

cGMP awareness

SOP execution

Education

High School Diploma or GED

Associate's degree or higher

Job description

The incumbent will be a shop floor employee in the manufacturing organization.The incumbent will provide (be trained in) the technical skill-sets necessary to manufacture high-quality biologicals safely in a compliant, efficient, and cost-effective manner.

• Shift: Nights
• Hours: 6PM – 6AM
• Follows 2-2-3 schedule

Responsibilities:

• Becomes trained on basic processes and equipment and serves as a hands-on resource in Production
• Conducts all assigned activities in a safe and cGMP compliant manner. Tasks will include, but are not limited to:
• Cleaning, preparing, and sterilizing production equipment
• Cleaning and disinfecting production rooms
• Assembly, set-up, and disassembly of production equipment
• Executing process steps according to defined SOPs and BPRs
• Documenting activities in accordance with cGMPs
• Handling biologically and chemically hazardous goods
• Interfacing with process automation systems and electronic business systems (e.g, PAS, BAS, PLCs, LIMS, SAP, LiveLink)
• Supporting Qualification and Validation activities
• Identifying and communicating process issues

• Supports team effort in the effective and timely completion of root cause investigations and CAPA
• Supports a high-performance teamwork environment and demonstrate Seqirus Values and Behaviors

Qualifications:

• High school diploma/GED or associate’s degree with 1+ years’ transferrable skills OR bachelor’s degree with 0+ years’ experience OR equivalent; experience in pharmaceutical, biotechnology, and/or sterile production environments preferred
• Basic knowledge of cGMP requirements preferred
• Experience executing SOPs and documenting work preferred
• Basic mechanical aptitude or knowledge of electronic / mechanical equipment preferred

Different qualifications or responsibilities may apply based on local legal and/or educational requirements. Refer to local job documentation where applicable.