Biotech Manufacturing Associate – cGMP Operations

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

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.