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Capital Project Engineer

2 months ago

Marquand, Missouri, United States Novartis Group Companies Full time

Job Summary:

Novartis Group Companies is seeking a highly skilled Site Equipment Manager to lead the equipment and CQV engineering team at a GMP Radioligand Therapies Isotope Production Facility. As a key member of the site's leadership team, you will be responsible for commissioning, qualification, and start-up of GMP production equipment, ensuring operational readiness and compliance with all applicable quality and HSE regulations.

Key Responsibilities:

  • Team Leadership: Manage a team of GMP equipment asset owners, overseeing the complete GMP lifecycle from URS through to CQV and placing into operational use.
  • Equipment Management: Manage a team of CQV/CSV and Equipment Engineers to maintain equipment reliability and ensure compliance with all applicable quality and HSE regulations and requirements.
  • Quality and Compliance: Promote a strong quality and compliance mindset, supporting timely closure of Equipment Engineering and CQV-related cGMP deficiencies, including audit observations, CAPAs, and deviations.
  • Capital Projects: Manage capital projects involving equipment upgrades, planning, execution, and documentation (URS, FRS, Specifications).
  • Reporting and Communication: Provide timely reporting to management on progress, priorities, timelines, and sharing of necessary information.
  • Vendor Management: Contract and manage outside vendors and contractors to fulfill business needs.
  • CQV Planning: Author and/or manage authoring of CQV plans, qualification protocols, qualification summary reports, and requirement trace matrices.
  • Continuous Improvement: Drive continuous improvement to meet world-class standards using operational excellence principles while developing best practices.
  • Talent Development: Oversee recruitment, training, and manage qualified professionals, coaching, developing, and growing talent within the team.
  • CQV Program Management: Manage the complete CQV and CSV program, from site VMP, compliance with all qualification standards, and through to periodic review and ensure validated state is maintained.
  • Subject Matter Expert: Serve as a subject matter expert at the site to support internal and/or external inspections.
  • Financial Management: Capable of managing capital project capex and qualification team budgets and supports site cost improvement initiatives.
  • Policies and Procedures: Support the development of CQV and CSV policies and procedures to maintain compliance with site, corporate, and regulatory standards.
  • Site Operations: Support 24x7 site-based operations after startup.

Requirements:

  • Bachelor's degree in engineering, computer science, automation, or a related field is required.
  • 5+ years of relevant engineering experience in the Chemical or Pharmaceutical industry is required.
  • Experience hiring, managing, and developing technical resources in an operating GMP environment is required.
  • In-depth knowledge of FDA regulations and particularly 21 CFR part 11, GAMP5, and GMP systems is required.
  • Excellent oral and written communication skills are required.
  • 5-10% travel is required.