Sr Lead Manufacturing Associate

CSL•Holly Springs, NC

3d•Onsite

About The Position

The Sr Lead Manufacturing Associate works onsite at Seqirus’s Holly Springs, North Carolina facility within manufacturing operations and reports to the Supervisor. The role provides and trains team members in the technical skills needed to manufacture high-quality biological products safely, compliantly, efficiently, and cost-effectively. It serves as a hands-on production leadership position, including assigning work, coordinating team and equipment resources, and managing the team when the Supervisor is absent. The position works a day shift from 6 a.m. to 6 p.m. on a 2,2,3 rotation.

Requirements

High school diploma or equivalent vocational or technical education.
Expert knowledge of cGMP requirements.
Experience executing SOPs and documenting work.
At least 5 years of production experience.

Responsibilities

Serve as the hands-on leader for the Production team.
Assign activities across the team.
Assemble, set up, and disassemble production equipment.
Complete process steps according to defined SOPs and BPRs.
Document activities and review documentation in accordance with cGMPs.
Work with automation systems and use electronic business systems such as PAS, BAS, PLCs, LIMS, and SAP.
Collaborate with engineering, maintenance, and automation groups on project activities.
Participate as a subject matter expert in revisions to SOPs and BPRs 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 the team’s point of contact and manage the team when the 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 complete CAPAs for deviations.
Exhibit Seqirus Values and Behaviors.