Associate I, Manufacturing

CSL; Holly Springs (NC); On-site; USD 25,000 - 33,000; Full time

Job summary

CSL in North Carolina seeks a night-shift production operator to support manufacturing of biologics in a cGMP environment. You will be trained on processes and equipment and work on a 2-2-3 schedule, 6 PM–6 AM.

Responsibilities include operating and sanitizing production equipment, maintaining cleanrooms, documenting steps, and interfacing with process automation and SAP/LIMS systems. Prior technical or pharma exposure is preferred.

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

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

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.