What are the responsibilities and job description for the Associate I/ II/ III, Manufacturing (Night Shift) position at CSL?
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.
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
- Shift: Nights
- Hours: 6PM – 6AM
- Follows 2-2-3 schedule
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