Senior Manufacturing Lead, Biotech Production & GMP

CSL; Holly Springs (NC); On-site; USD 65,000 - 90,000; Full time

Job summary

Seqirus in Holly Springs, NC, is seeking a Sr. Lead Associate in Manufacturing Operations to lead the production team and ensure high-quality biologicals are manufactured safely and efficiently. The role involves training, SOP/BPR adherence, and collaboration with engineering, automation, and quality teams.

You will report to the Supervisor, work on a 6am–6pm day shift with a 2-2-3 rotation, and be onsite at the Holly Springs facility to support continuous improvement and compliant operations.

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

• 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.

Education

High School Diploma or equivalent vocational or technical education

Job description

Seqirus in Holly Springs, NC, is seeking a Sr. Lead Associate in Manufacturing Operations to lead the production team and ensure high-quality biologicals are manufactured safely and efficiently. The role involves training, SOP/BPR adherence, and collaboration with engineering, automation, and quality teams.

You will report to the Supervisor, work on a 6am–6pm day shift with a 2-2-3 rotation, and be onsite at the Holly Springs facility to support continuous improvement and compliant operations.