Lead Tech, Operations (Operational Compliance)

Job Description

Our Manufacturing Operations teams are the people that make our products. We work in the manufacturing plants with a “Safety First, Quality Always” mindset striving for continuous improvement. We work in the local plant connected to our global manufacturing network to ensure the highest quality of raw materials, intermediates and finished products. 

Position Description 

This is a day/night shift position, 12.5 hour (6:00 AM - 6:30 PM; 6:00PM-6:30AM) rotation (2-2-3).  

The Vaccine Manufacturing Facility Lead Technician is an excellent opportunity for highly motivated individuals with expertise working in aseptic production and manufacturing operations.  The Lead Technician is a manager developmental role and will serve on the Operations leadership team.  Key responsibilities of the Lead Technician include direct support of operations on the production floor, coordination across processing suites, real-time batch record review, execution of aseptic processing requirements as needed, adherence to Good Manufacturing Practices, and leading in a team environment to accomplish shift and departmental goals.  The ideal candidate for this position has demonstrated the ability to manage their own work activities as well as activities of others, contributing toward the success of the team through the use of their decision-making and problem-solving skills and their knowledge of aseptic manufacturing. 

Responsibilities include, but are not limited to: 

• Executes operational review and comment resolution of batch records to include binder assembly.

• Maintains gown qualification.

• Maintains qualification within at least 1 suite

• Reviews and completes documentation to support production activities, including batch record events and management of forms and labels on the shop floor. 

• Assist with label preparation (e.g., GLIMS, Release) for upcoming production

• Executes operation sample management of samples handled within Durham

Review special communications at shift change to include 4-Quad.

• Executes room incursion initiation and approvals

• Assists Manager in leading a team-based culture through continuous improvement activities 

• Assist Manager with facilitating shift change. 

• Performs inventory control and cycle counts. Resolves and reports issues with product accountability and SAP system discrepancies. 

• Assists team in real-time batch record review and ensures timely closure of shopfloor order.

• Demonstrates a strong problem-solving ability to troubleshoot and communicate appropriately and effectively 

• Conforms to established safety procedures in accordance with OSHA and other regulatory agencies 

• Identifies and addresses compliance, environmental, safety, and process deviations as required and escalates to appropriate personnel. . 

• Serves as a back-up to the Operations Coach on shift, as required. 

• Serves as back-up to the suite O4 or other missing role to support daily processing activities, as required.

Education Minimum Requirement:  

• High School Diploma or equivalent is required for this position. 

• Associate's or Bachelor’s degree in Life Science or Engineering preferred.

Required Experience and Skills:  

• Qualified in at least 1 manufacturing area.

• Technical writing experience, i.e. investigations, change requests, standard operating procedures, batch records, protocols. 

• Must be able to work both independently and within multi-functional teams in a fast-paced environment. 

• Experience with pharmaceutical process systems including PAS-X, DeltaV, SAP, RtReports, GLIMS

• At least four (4) years GMP manufacturing/processing experience or at least two (2) years GMP manufacturing/processing experience with a Bachelor’s degree in Life Science or Engineering 

• Must be willing to work 12-hour day/night shift (6:00 AM to 6:30 PM; 6:00PM-6:30AM) on a rotating 2-2-3 schedule.  Note that this schedule does include working alternating weekends and holidays  

• Must be able to successfully pass and maintain aseptic gowning qualification.