Sr Lead Manufacturing Associate
CSL
Summary
Reporting to the Supervisor, you will be onsite working in our Holly Springs facility as a Sr. Lead Associate within 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.
Job description
Responsibilities
- You will be the hands-on leader in Production for the team
- Assign activities across the team
- Assembly, set-up, and disassembly of production equipment
- Complete process steps according to defined SOPs and BPRs
- Document activities and review of documentation following cGMPs
- Work with automation systems and advanced user of electronic business systems (e.g, PAS, BAS, PLCs, LIMS, SAP)
- Collaborate with supporting groups (engineering, maintenance, automation) on project activities
- Participate as a subject matter expert for SOPs and BPRs revisions as needed
- Coordinate Qualification and Validation activities
- Train team members to support team flexibility
- Coordinate equipment and personnel resources on daily basis
- Be point of contact and manage team when Supervisor is not present
- Collaborate with FLQA to resolve quality issues
- Support the collection and tracking of area metrics and process control data
- Support complex investigations and CAPA completion for deviations
- Exhibit Seqirus Values and Behaviors
Qualifications
- High School Diploma or equivalent vocational or technical education
- Expert knowledge of cGMP requirements required
- Experience executing SOPs and documenting work required
- 5+ years' production experience
Requirements
- High School Diploma or equivalent vocational or technical education
- Expert knowledge of cGMP requirements required
- Experience executing SOPs and documenting work required
- 5+ years' production experience
Company overview
CSL Limited is an Australian multinational specialty biotechnology company that researches, develops, manufactures, and markets products to treat and prevent serious human medical conditions. Founded in 1916 as Commonwealth Serum Laboratories, CSL has grown to become the world's fifth largest biotechnology company with operations in over 35 countries. The company specializes in blood plasma derivatives, vaccines, antivenoms, and cell culture reagents used in medical and genetic research applications. CSL operates through several key divisions including CSL Behring (focusing on rare and serious diseases), CSL Seqirus (one of the world's largest influenza vaccine providers), CSL Plasma, and CSL Vifor. With over 32,000 employees globally, CSL maintains a strong R&D pipeline and has invested over US$3.3 billion in research and development over the past five years. The company is publicly traded on the Australian Securities Exchange and has its global headquarters in Parkville, Melbourne, Australia.