GSK-posted 3 months ago
Full-time • Mid Level
Zebulon, NC
5,001-10,000 employees
Chemical Manufacturing

Are you looking for an engineering role that allows you to leverage your technical knowledge in a state-of-the-art manufacturing environment? If so, this Production Engineering Manager Professional role could be an ideal opportunity to explore. As Production Engineering Manager, you will be responsible for implementation and scheduling of a comprehensive predesigned qualification program for the manufacturing plant including its equipment, facilities and utilities. This role will provide YOU the opportunity to lead key activities to progress YOUR career.

  • Schedule and execute site equipment, facilities and utilities in a qualified state
  • Develop strategies to meet requirements for the site master validation plan
  • Plan, organize and prioritize staffing as to manage to the site Master Validation Plan for equipment, facilities and utilities
  • Develop and execute documentation and protocols required to support all changes to do the installation of new equipment and manufacturing processes as well as any changes resulting from factory maintenance activities or interventions
  • Participate on the site Validation Governance Board in collaboration with other board members and stakeholders and set site wide strategies
  • Make fully informed decisions and provide compliance and technical solutions
  • Provide managerial oversight to the assigned team of Engineers to fully develop work potential, prepare for promotional opportunity and provide a sense of job satisfaction
  • Maintain a solid understanding of current FDA, Current Good Manufacturing Practices (cGMP), corporate guidelines, and industry best practices for this field and implement these standards daily
  • Responsible for on time compliance records of project engineering department
  • Manage department budget and support departmental, plant, and corporate goals
  • Manage vendors and consultants to ensure that contracts contain appropriate technical specifications are delivered as required
  • Provide technical expertise during regulatory audits
  • Participate in site Operational Excellence initiatives and author, review, revise, or approve Standard Operating Procedures (SOP's) as required
  • Provide technical support for utility systems including purified water systems, compressed air systems, chilled water systems and steam systems
  • Bachelor's degree in mechanical or chemical engineering
  • Experience working in a highly regulated Good Manufacturing Practices (GMP) environment
  • Experience leading facility equipment programs and leading maintenance teams
  • Leadership experience in coaching and collaborative working
  • 5+ years of experience in the pharmaceutical industry
  • Familiarity with manufacturing regulatory requirements
  • Strong written and verbal communications skills
  • Ability to influence at all levels
  • Onsite cafeteria
  • Onsite gym
  • Temperature-controlled climate
  • Licensed, onsite Health & Wellness clinic
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