Senior Specialist, Operations

Job Description

• Supports the end-to-end product Value Stream Map driving production improvements, inventory management, cost reductions, and standard work at the shop floor level.
• Collaborates with Operations, Technology and Quality to author regulatory inspection observation responses and completes remediation projects, as required.
• Assists shift managers in providing leadership to the production floor. Capable of providing primary leadership to team during extended periods of manager absence such as vacations
• Serves as liaison between the team and support groups in resolving day to day issues and in support of various projects and initiatives including the tech transfer of new products
• Author and own execution of Operations protocols
• Develop and own Operations corrective actions
• Author and revise Standard Operating Procedures
• Support of internal and external regulatory inspections, presenting on topics as needed.
• Executes and manages Operations batch record review within established timelines for release and effectively liaisons with Quality to resolve comments in a timely manner
• Day shift Operations representative for various site needs (Quality Assessments, Process Simulation support, etc.)
• Leads/Supports production and quality projects and process system improvements
• Lead problem-solving of real-time shop floor issues
• Support investigations of process deviation events
• Provide expertise to the production floor, understanding the full process requirements (safety, compliance, equipment, regulatory) in order to best understand and resolve production issues.
• Works independently and is capable of balancing shifting priorities without introducing disruption to the organization. Capable of working through uncertainty with minimal levels of manager direction.
• Potential to work on shift directly with an Operations team as needed for shop floor support.

• Bachelor Degree (science/chemical, mechanical, or electrical engineering preferred)
• Bachelor of Science (B.S.) degree in Engineering (such as Chemical, Mechanical, Bio-Engineering, Bio-Medical Engineering, Industrial Engineering, etc.) or Science Fields (such as Chemistry, Biology, Microbiology, etc.) strongly preferred

• Minimum five (5) years of relevant experience in a manufacturing, technical, or mechanical support role in a high-volume lean operation
• 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.

• Sterile manufacturing shop floor experience highly preferred.
• Working knowledge of cGMPs and of regulatory requirements as they apply to the vaccine/pharmaceutical industry.
• Experience with formal problem-solving techniques and a hands-on approach to problem-solving, such as root cause analysis and/or Lean Six Sigma tools.
• Experience using inventory management and maintenance planning software (MRP/ERP) such as SAP, automated control systems and electronic batch record systems.
• Experience managing against metrics and scorecards in a business environment.
• Experience with presenting to an internal / regulatory auditor.
• Advanced knowledge of Excel, Minitab, JMP, and/or Statistical analysis.
• Six Sigma certification.

Analytical Problem Solving, cGMP Compliance, Collaboration, Competency Management, Corrective Action Management, Data Analysis, Decision Making, Manufacturing Processes, Operations Support, Process Improvements, Production Scheduling, Regulatory Management, Root Cause Identification, Site Operations, Standard Operating Procedure (SOP), Technical Writing, Training and Development, Vaccine Manufacturing, Working Independently

Our company is committed to inclusion, ensuring that candidates can engage in a hiring process that exhibits their true capabilities. Please  if you need an accommodation during the application or hiring process.

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