Associate, Manufacturing (Small Scale Filling)

CSL Plasma; Holly Springs (NC); On-site; USD 40,000 - 60,000; Full time

Benefits offered by this job

Onsite Café

Walking trail

Basketball and Tennis Courts

Medical insurance

Dental insurance

Vision insurance

401K with 6% match

Annual bonus

PTO

Wellness days

Floating holidays

Job summary

Seqirus in Holly Springs, NC, is seeking an on-site Manufacturing Operator to join the shop floor. You will train to perform core production tasks safely, accurately, and in compliance with cGMP standards on high-quality biological products.

The role focuses on equipment setup, process execution, and documentation, with involvement in qualification, validation, and CAPA activities. Strong mechanical aptitude and familiarity with SOPs are required.

Qualifications

• High school diploma/GED required; biotechnology coursework a plus.
• Minimum of 2 years transferrable biomanufacturing experience or equivalent education.
• Experience in pharmaceutical, biotechnology, or sterile production environments.
• Basic knowledge of cGMP requirements preferred.
• Experience completing SOPs and documenting work.
• Basic mechanical aptitude or knowledge of electronic/mechanical equipment preferred.

Responsibilities

• Train on basic processes and equipment; serve as hands-on Production resource.
• Perform activities in a safe and cGMP compliant manner.
• Clean, prepare, and sterilize production equipment; disinfect rooms.
• Assemble, set-up and disassemble production equipment.
• Follow SOPs and BPRs for process steps and document activities.
• Handle biologically and chemically hazardous materials.
• Interface with process automation and electronic systems (e.g., PAS, BAS, PLCs, LIMS, SAP, LiveLink).
• Participate in Qualification and Validation activities.
• Contribute to root cause investigations and CAPA implementation.

Skills

cGMP knowledge

SOP documentation

Equipment setup

Process automation interfaces

Safety compliance

Education

High School Diploma / GED

Biotechnology coursework (plus)

Tools

PAS

BAS

PLC

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 the state-of-the-art manufacturing facility and an 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 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. Our benefits include an Onsite Café, 1/2 mile Walking Trail, Basketball and Tennis Courts; access to Medical, Dental, Vision, Life Insurance, 401K with a 6% match and an annual bonus; and accrued PTO, wellness days and floating holidays.

Reporting to the area Manager, you will work onsite on the shop floor employee in manufacturing operations. You will provide (train in) the technical skill-sets necessary to manufacture high quality biologicals safely in a compliant, efficient, and cost-effective manner.

Shift: DayHours: 8-5pmFollow M-F scheduleJob level will be determined based on years of relevant experience to our processes and equipment

Responsibilities:

• Become trained on basic processes and equipment and serves as a hands-on resource in Production.
• Conduct all assigned activities in a safe and cGMP compliant manner.
• Clean, prepare, and sterilize production equipment and disinfect production rooms.
• Assembly, set-up, and disassembly of production equipment.
• Execute process steps according to defined SOPs and BPRs.
• Document activities following cGMPs.
• Handle biologically and chemically hazardous good.
• Interface with process automation systems and electronic business systems (e.g, PAS, BAS, PLCs, LIMS, SAP, LiveLink.)
• Involved in Qualification and Validation activities.
• Involved in completion of root cause investigations and CAPA implementation.

Qualifications:

• High school diploma/GED required, with training and education from biotechnology coursework being a plus;
• Minimum of 2 years of transferrable skills and experience OR equivalent education, coursework or hands-on training in biomanufacturing related areas;
• experience in pharmaceutical, biotechnology, or sterile production environments.
• Basic knowledge of cGMP requirements preferredExperience completing SOPs and documenting workBasic 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.