Manufacturing Group Leader V

Objective

Assists Production Supervisor in carrying out the day‑to‑day operation and guidance of production personnel involved in manufacturing of product for the facility. Helps maintain general control to ensure compliance with domestic FDA/GMP and all international regulatory requirements. Assists Supervisor in ensuring compliance is maintained in the area concerning environmental, health and safety practices. Trains, facilitates, and oversees manufacturing associates to accomplish established work objectives.

• Assist Supervisor in managing the daily production schedule for manufactured products to ensure that products are produced according to prescribed schedule and established quality standards.
• Understand and execute daily staffing plan to ensure department quality and quantity objectives are achieved. Arrange overtime as required according to overtime policy and Tier 1 data.
• Provide technical leadership to employees in work; ensuring associate compliance to SOP and procedure changes; ensure assigned end of shift activities are performed. Instruct and train associates in proper setup, operation, inspection, maintenance and troubleshooting operations.
• Demonstrate critical thinking skills to address challenges that may arise in production, staffing, etc. Promote efficiency and productivity across operational processes.
• Arrive early to ensure an approved shift hand‑off and complete shift reports and shift hand‑off to incoming shift. Provide necessary data for reporting.
• Assist in monitoring the conduct and updating on an ongoing basis the training of personnel, as well as the testing of new processes and procedures, to ensure that both production personnel and process conform with GMP’s and all regulatory and safety requirements.
• Communicate to and support Supervisor with any employee conduct concerns, and drive resolution of any instances of non‑compliance. Hold associates accountable to company standards & guidelines.
• Perform corrective and preventative maintenance as needed, in cooperation with Plant Maintenance and other shifts. Enlist technical support if needed. Verify all preventive maintenance logs are updated and that all areas have the required equipment to perform their tasks. Resolve any unusual conditions or problems and elevate instances where further support is required to shift Team Leader.
• Perform in‑process inspections, ensure validation requirements are known and understood by MAs. Ensure proper hand‑off of validation requirements between shifts, monitor validation progress during shift and ensure personnel are processing the validations per procedure.
• Demonstrate in depth knowledge of all job functions within the area, perform all jobs as needed and guide/ train team to maintain production throughput. Will be a working group lead when not supporting other activities defined by LSW.
• Assist with nonconformance initiations, root cause investigations, and corrective action closeout.
• Capable of identifying and leading lean activities. Proactively use Tier 1 Data to drive improvements within area of responsibility or even other areas of similar processes.

• Education:
  
  High school diploma or general education degree (GED) required. Associate’s degree or certifications in related technical field or relevant experience preferred.
• Special
  
  Skills:
  
  Demonstrated knowledge of computers and software, strong troubleshooting skills, good verbal/written skills, proficiency in MS Office Outlook / Word / Excel.
• Experience:
  
  5+ years related experience in Medical Device Manufacturing or equivalent combination of education and experience. Previous leadership experience preferred.
• Specialized Training:
  Demonstrated knowledge of computers to include use of CAMS and email. Knowledge and understanding of cGMPs and ISO standards.

This position may be available in the following location(s): US – Wilmington, MA.

All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or veteran status.

For U.S. locations that require…