Group Leader

8 - 10 years experience  • 

Salary depends on experience
Posted on 03/27/18
8 - 10 years experience
Salary depends on experience
Posted on 03/27/18

Responsibilities

  • Hands-on project and technical leader with extensive subject matter expertise (SME) in class II and III pharmaceutical and medical device industries
  • Manage the optimization of the tech transfer of new and current process systems to support manufacturing activities and to develop manufacturing processes for high volume and throughput
  • Provide project and engineering leadership in the identification, feasibility, development, qualification and launch of new products, including identification of user needs, specification development, test development, design verification and validation testing, risk assessments
  • Provide leadership in the area of continuous improvement to significantly impact Cost Standards, Operations/Business System Efficiency and elimination of non-value added work
  • Mange Advance Process Development and new Product Introduction activities including characterizing and implementing automated manufacturing processes and equipment
  • Extensive expertise in managing project plans and executions including defining risks and recommend contingency plans to maximize successful outcome
  • Lead cross departmental teams to develop and establish robust project schedules, assign key deliverables and communicate expectations and progress updates
  • Lead all project execution activities and oversee the development of statistically sound process and equipment validation & qualification protocols/reports activities
  • Define and generate all required documentation in support of manufacturing products and processes. Including designing and writing engineering protocols in compliance with GMPs and internal procedures, PFMEs, reports, manufacturing instructions and procedures. Use of appropriate six sigma methodologies such as Design of Experiments (DOEs), Gage R&R, and other statistical tools as necessary
  • Establish and foster strong collaborative relationships with internal and external partners and stakeholders and outside vendors
  • Manage analysis of manufacturing data and support development of database for the collection, control, and access of key process and development data
  • Prepare technical reports, analysis, recommendations and presentations reflecting the status and results of projects in progress on a regular basis
  • Develop, implement, train and monitor effectiveness of engineering systems and procedures to ensure compliance to FDA, GMP and all other applicable agency regulations
  • Coach, manage and develop technical staff
  • Hires and retains a diverse, highly qualified staff and provides ongoing performance feedback. Sets goals which align to department plans and manages the execution of goals through coaching and mentoring. Maintains a safe and professional work environment
  • Ensures activities performed are in compliance with quality system policies/regulations and Good Manufacturing Practices (GMP) at all times
  • Be agent of change in utilizing Product life cycle management (PLM) to control changes, documents, during process development and transfer
  • Drive improvements on quality, reliability, cost, yield, process stability/capability, productivity and safety/ergonomic over variables such as material, method, equipment, environment and operating personnel.

Qualifications

  • Bachelor’s degree or equivalent in field relevant to specialty area
  • 8+ years experience leading projects in specialty area, or equivalent combination of education and experience
  • Advanced degree in related field preferred
  • Process development, equipment design and validation
  • Extensive project management
  • A strong knowledge of development & commercialization of regulated devices in accordance FDA Part 820 & ISO 13485 Quality System Regulations
  • SME in PFMEA, ECO, CAPA, NCR, RCA
  • Lean manufacturing, Six Sigma and Minitab statistical tools (SPC, Gage R&R, DOE, etc.)
  • Leadership and strong interpersonal skills

Requisition ID 2018-6293

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