Sr Lead Manufacturing Associate

CSL Plasma; Holly Springs (NC); On-site; USD 85,000 - 120,000; Full time

Job summary

Seqirus in Holly Springs, NC is seeking a Sr. Lead Associate to join our manufacturing operations team.

This on-site role focuses on leading a production group, ensuring high-quality biologics manufacturing while complying with cGMP standards and SOPs. You'll supervise daily activities, coordinate equipment and personnel, and collaborate with engineering, maintenance, automation, and QA to drive quality and efficiency in a state‑of‑the‑art facility in the fight against influenza and related

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.

Responsibilities

• Hands-on production leadership for the team.
• Assign activities across the team.
• Assemble, set-up, and disassemble production equipment.
• Complete process steps per SOPs and BPRs.
• Document activities and review documentation per cGMPs.
• Work with automation systems and electronic business systems (e.g, PAS, BAS, PLCs, LIMS, SAP).
• Collaborate with engineering, maintenance, automation on project activities.
• 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 collection and tracking of area metrics and process control data.
• Support complex investigations and CAPA completion for deviations.
• Exhibit Seqirus Values and Behaviors.

Skills

Team leadership

Process documentation

Education

High School Diploma or equivalent vocational or technical education

Tools

PAS

BAS

PLC

LIMS

SAP

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.

Day Shift - 6am - 6pm2,2,3 rotation

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.

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 mange 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

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