Associate I/ II/ III, Manufacturing (Night Shift)

CSL; Holly Springs (NC); On-site; USD 42,000 - 60,000; Full time

Job summary

CSL in Holly Springs, NC is seeking a shop floor Production Operator to support manufacturing of biologicals on a 12-hour night schedule. You will be trained to perform basic processes, operate equipment, and assist in qualification activities within a compliant, efficient environment.

Responsibilities include cleaning, sterilizing equipment, documenting SOPs/BPRs, and interfacing with PAS, LIMS, and SAP systems.

Qualifications

• High school diploma or GED or related degree required or preferred.
• Experience in pharma/biotech sterile production is preferred.
• Basic knowledge of cGMP requirements preferred.
• Experience executing SOPs and documenting work is preferred.

Responsibilities

• Becomes trained on basic processes and equipment and serves as a hands-on resource in Production.
• Conducts all activities in a safe and cGMP compliant manner.
• Cleaning, preparing, and sterilizing production equipment.
• Cleaning and disinfecting production rooms.
• Assembly, setup, and disassembly of production equipment.
• Executing process steps according to 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.
• Supporting root cause investigations and CAPA.
• Contributing to a high-performance teamwork environment and Seqirus values.

Skills

Mechanical aptitude

SOP execution

cGMP knowledge

Documentation

Equipment knowledge

Education

High school diploma / GED

Associate’s degree

Bachelor’s degree

Tools

PAS

BAS

PLC

LIMS

SAP

LiveLink

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.