Associate I, Manufacturing

CSL Plasma; Holly Springs (NC); On-site; USD 35,000 - 62,000; Full time

Job summary

CSL Plasma is seeking a shop floor operator for our manufacturing organization in Holly Springs, NC. You will be trained to manufacture biologicals safely, efficiently and in compliance with cGMP standards during Nights (6PM–6AM, 2-2-3).

Responsibilities include cleaning, setup, SOP execution, and documentation, while interfacing with PAS/BAS/PLCs/LIMS/SAP/LiveLink. Prior sterile production or pharma exposure is preferred; basic mechanical aptitude is a plus.

Qualifications

• High school diploma/GED or associate's degree with 1+ years transferrable skills OR bachelor's degree with 0+ years experience.
• Pharmaceutical, biotechnology and/or sterile production experience 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 activities in a safe and cGMP compliant manner.
• Cleaning, preparing, and sterilizing production equipment.
• Cleaning and disinfecting production rooms.
• Assembling, setting up, and disassembling 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.

Skills

Safety awareness

SOP execution

Documentation

Education

High school diploma/GED or associate's degree with 1+ years transferrable skills OR bachelor's degree with 0+ years experience

Tools

PAS

BAS

PLCs

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.