Lead Technician, Operations

MSD•Durham, NC

2d•$77,700 - $122,300•Onsite

About The Position

This role supports production activities for the commercial manufacture/fill/inspection of material within Drug Product Operations. The Lead Technician will coach new trainees, perform manual and automated operations, and conduct general maintenance. They will also be responsible for documentation, inventory, and transportation of equipment and materials. Additionally, the role involves authoring, reviewing, and editing procedures and technical documents, troubleshooting equipment, performing housekeeping, and executing facility decontamination. The technician will also perform sampling and in-process testing, participate in various operational and safety initiatives, and contribute to cross-functional manufacturing teams. The position requires analyzing and implementing initiatives to increase departmental success and participating in new hire training programs. The role will primarily support 1st shift Drug Product Operations, Monday-Friday, 6:00 AM-2:30 PM, but requires flexible hours to support 1st/2nd DP shifts and the overall process.

Requirements

Minimum three-year relevant work experience in GMP environment
Demonstrated written and verbal communications skills
Must be willing and able to lift 50 lbs
Must be willing and able to work on elevated platforms

Nice To Haves

Demonstrated 2-4 years of leadership experience
Applicable mechanical and project management experience
Proficiency with automated systems (MES, SAP, DeltaV)
Experience training others and/or leading hands-on or instructor-led training
Demonstrated knowledge of Lean Six Sigma/MPS principles
Experience with on-the-floor cGMP manufacturing and familiarity with regulatory requirements
Demonstrated ability to work both independently and as a part of a team
Strong collaboration, communication, and leadership skills

Responsibilities

Effectively coach new trainees to build their skills so that they may become effective operations technicians and SMEs.
Support production activities for the commercial manufacture/fill/inspection of material.
Perform manual and automated operations, general maintenance and support functions necessary for the production.
Provide and/or author all documentation and clerical functions necessary to allow proper accountability and traceability of product.
Maintain, inventory, and transport all required equipment, materials, supplies and products.
Author, review, and/or edit procedures and technical documents to support regulatory filings including standard operating procedures, job-aides, and learning documents.
Perform general maintenance and assist or troubleshoot equipment independently.
Perform housekeeping in all work areas.
Execute facility decontamination according to procedures.
Maintain, clean and prepare equipment used in production.
Identify and address compliance, environmental, safety, and process deviations as appropriate while notifying appropriate personnel.
Perform sampling/in-process testing supporting the manufacturing and validation process for current process as well as developmental work for new products/processes as required independently.
Attend and actively participate in HAZOPS, waste walkthroughs, 5S, kaizen events, or any other operations, lean six-sigma, quality, safety or environmental training/initiatives as required.
Promote a culture of visibility and accuracy of the project schedule and update dashboards accordingly to highlight project status to critical milestones.
Actively participate on cross-functional manufacturing teams to advance projects goals and deliverables related to the vaccine process.
Analyze and implement initiatives, training programs, and systems that will help to increase overall success within the department.
Participate in training for new hire training programs.
Participate in product/material inspection efforts.
Work flexible hours to support 1st/2nd DP shifts, as well as the overall process.