Associate I, Manufacturing

CSL; Holly Springs (NC); On-site; USD 42,000 - 66,000; Full time

Job summary

Seqirus in Holly Springs, NC is seeking an entry-level shop floor operator for the manufacturing organization. You will learn to perform essential production tasks safely and in a compliant manner.

You will gain hands-on experience with equipment, SOPs, GMP records, and process systems while supporting cleaning, assembly, and qualification activities. The role requires safety-minded teamwork and a commitment to high quality.

Qualifications

• High school diploma/GED or associate degree with 1+ years transferrable skills, or bachelor’s with 0+ years experience.
• Pharmaceutical/biotechnology 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 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

Skills

cGMP knowledge

SOP execution

Documentation

Mechanical/electronic aptitude

Education

High school diploma/GED or associate degree

Bachelor’s degree (0+ years) in related field

Tools

PAS

BAS

PLCs

LIMS

SAP

LiveLink

Job description

Do you want to work with a company that tackles fascinating problems and find solutions to complex challenges? Seqirus has an exciting opportunity to join our expanding team in Holly Springs, NC. With an advanced manufacturing facility and expertise in influenza science we are one of the world leaders in the production of the influenza vaccine. We operate as one integrated global company, drawing together expert staff from different countries to collaborate. Together, we're working on the front line to protect communities from seasonal influenza and global pandemic threats. When you join Seqirus, you join a team dedicated to making a difference in people's lives. It's a feeling of possibility, creativity, and purpose that inspires us every day.

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.