Lead Manufacturing Technician (2nd Shift Sun-Wed)

  • Company: Shire plc
  • Location: Massachusetts, United States
  • Posted: November 09, 2017
  • Reference ID: R0015453
Primary Role:
With minimal supervision this individual will deliver leadership and excellence in manufacturing processing as well as scheduling to meet site demands . Oversees and executes floor operations to ensure safety, aseptic operations and compliance with cGMPs are maintained at all times. Ensures efficient use of material and equipment and assigns personnel as appropriate in the execution of day to day operations. Provide technical support through interactions with support groups to ensure accurate and well managed transfer of process changes/improvements to floor operations. Provide support to integrate best practices, where appropriate, into manufacturing.

70%: Processing

• Primary contact for troubleshooting and issue resolution or escalation
• Create and follow-up on work orders
• Communicate/ coordinate days scheduling and staffing plan
• Re-allocate staff as needed during the day (breaks, lunch, training, etc)
• Oversight and execution of all routine and critical operations as well as commissioning and validation activities
• Ensure documentation is complete, reviewed and meets good documentation practices (forms, logbooks, form preps, batch records, etc.)
• Responsible for floor inventory and communicating schedule changes as needed
• Monitor material consumption and coordinate all materials deliveries
• Recommend/Implement process changes/improvements or safety/ergonomic improvements.
• Ensure work is carried out in a safe manner, notifying management of safety issues and risks

20%: People
• Responsible for interviewing candidates
o Provide timely feedback on staff's performance
o Address minor personnel issues timely
o Escalate major personnel issue to the supervisor
o Ensure staff compliance with all relevant SOPs, BR, FP and safety guidelines
o Act as a role model (Lead by Example)
o Act as a resource/SME for staff
o Ensure the use of safe work practices and behaviors

• Training o Conduct training and assess effectiveness
o Help identify training needs
o Assess staff skill sets and provide feedback to Supervisor.
o Develop training material
o Provide training

10%: Quality
• Initiate deviations or investigations of various complexities and work with cross-functional departments to identify root cause
• Implement appropriate corrective actions
• Complete action items for GMP investigations and CAPA's
• Assist supervisor/engineer/facilities with investigations
• Revise and author Standard Operating Procedures/Batch Records
• Communicate any quality issues/concerns to Supervisor and QA

Education & Experience Requirements:
Normally requires a high school diploma and 6+ years related industry experience or an Associates Degree in Life Sciences/Engineering field with 5 years of GMP Manufacturing experience. Biotech Certificate and prior leadership experience preferred. Experience with systems such as SAP, LIMS and TrackWise is a plus

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