Sr Lead Manufacturing Associate

About the role

Seqirus operates a state-of-the-art manufacturing facility in Holly Springs, NC and is one of the world leaders in the production of influenza vaccine. As a Sr. Lead Associate within manufacturing operations, you will provide the technical skill-sets necessary to manufacture high-quality biologicals safely in a compliant, efficient, and cost-effective manner. Reporting to the Supervisor, you will be the hands-on leader in Production for the team.

Schedule

Day Shift — 6:00 am to 6:00 pm on a 2‑2‑3 rotation.

Responsibilities

• 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 serve as an 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 SOP and BPR revisions as needed
• Coordinate Qualification and Validation activities
• Train team members to support team flexibility
• Coordinate equipment and personnel resources on a daily basis
• Act as point of contact and manage the team when the 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
• Experience executing SOPs and documenting work
• 5+ years' production experience

Different qualifications or responsibilities may apply based on local legal and/or educational requirements; refer to local job documentation where applicable.