Lead Technician, Operations

MSD • Durham, NC

14h • Onsite

About The Position

The Lead Technician, Drug Product Operations will support production activities for the commercial manufacture/fill/inspection of material. This role involves performing manual and automated operations, general maintenance, and support functions necessary for production. The technician will also be responsible for providing and/or authoring all documentation and clerical functions for proper accountability and traceability of product. They will maintain, inventory, and transport equipment, materials, supplies, and products. Additionally, the role requires authoring, reviewing, and/or editing procedures and technical documents to support regulatory filings, including standard operating procedures, job-aides, and learning documents. The Lead Technician will perform general maintenance, troubleshoot equipment independently, and execute facility decontamination according to procedures. They will also maintain, clean, and prepare equipment used in production, and identify and address compliance, environmental, safety, and process deviations. Sampling and in-process testing to support manufacturing and validation processes, including developmental work, will be performed independently. The role involves active participation in HAZOPS, waste walkthroughs, 5S, kaizen events, and other operations, lean six-sigma, quality, safety, or environmental training/initiatives. Promoting a culture of visibility and accuracy of the project schedule, updating dashboards, and actively participating on cross-functional manufacturing teams to advance project goals are key aspects. The Lead Technician will also analyze and implement initiatives, training programs, and systems to increase departmental success and participate in new hire training programs. Product/material inspection efforts and flexible work hours to support 1st/2nd DP shifts are also part of the responsibilities. The position will primarily support 1st shift Drug Product Operations, Monday-Friday, 6:00 AM-2:30 PM.

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.

Benefits

• medical, dental, vision healthcare and other insurance benefits (for employee and family)
• retirement benefits, including 401(k)
• paid holidays
• vacation
• compassionate and sick days
• annual bonus
• long-term incentive

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level
• Education Level: High school or GED