Manufacturing Associate (Upstream) – Day

CSL•Holly Springs, NC

1d•Onsite

About The Position

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 Supervisor or Sr. Lead, 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: Day Hours: 6AM – 6PM Follow 2-2-3 schedule Job level will be determined based on years of relevant experience to our processes and equipment The Role Become trained on basic processes and equipment and serve as a hands-on resource in Production. Conduct all assigned activities in a safe and cGMP compliant manner. Cleaning, preparing, and sterilizing production equipment. Clean and disinfect production rooms. Assembly, set-up, and disassembly of production equipment. Complete process steps according to defined SOPs and BPRs. Document activities following cGMPs. Handle biologically and chemically hazardous good. Work with process automation systems and electronic business systems (e.g, PAS, BAS, PLCs, LIMS, SAP, LiveLink.) Involved in Qualification and Validation activities. Identify process issues. Involved in completion of root cause investigations and CAPA. Work within a collaborative teamwork environment

Requirements

High school diploma/GED required, with training and education from biotechnology coursework being a plus
Minimum of 1 year 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 preferred
Experience completing SOPs and documenting work
Basic mechanical aptitude or knowledge of electronic / mechanical equipment preferred.

Nice To Haves

Experience with cell culture equipment or bioreactors for commercial cGMP manufacturing scale is an advantage

Responsibilities

Become trained on basic processes and equipment and serve as a hands-on resource in Production.
Conduct all assigned activities in a safe and cGMP compliant manner.
Cleaning, preparing, and sterilizing production equipment.
Clean and disinfect production rooms.
Assembly, set-up, and disassembly of production equipment.
Complete process steps according to defined SOPs and BPRs.
Document activities following cGMPs.
Handle biologically and chemically hazardous good.
Work with process automation systems and electronic business systems (e.g, PAS, BAS, PLCs, LIMS, SAP, LiveLink.)
Involved in Qualification and Validation activities.
Identify process issues.
Involved in completion of root cause investigations and CAPA.
Work within a collaborative teamwork environment