Site Equipment Specialist
3 weeks ago
Job Summary
Novartis is seeking a highly skilled and experienced professional to lead the equipment and CQV engineering team at a GMP Radioligand Therapies Isotope Production Facility. As the Equipment & CQV Workstream Lead, you will be responsible for commissioning, qualification, and start-up of the GMP production equipment through to operational readiness.
Key Responsibilities
- 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.
- Promote a strong quality and compliance mindset, supporting timely closure of Equipment Engineering & CQV related cGMP deficiencies, including audit observations, CAPAs, and deviations.
- Manage capital projects involving equipment upgrades, including planning, execution, and documentation.
- Provide timely reporting to management on progress, priorities, timelines, and sharing of necessary information.
- Contract and manage outside vendors and contractors to fulfill business needs.
- Author and/or manage authoring of CQV plans, qualification protocols, qualification summary reports, and requirement trace matrices.
- Drive continuous improvement to meet world-class standards using operational excellence principles and develop best practices.
- Oversee recruitment, training, and manage qualified professionals, coaching, developing, and growing talent within the team.
- Manage the complete CQV & CSV program, from site VMP, compliance with all qualification standards, through to periodic review, and ensure a validated state is maintained.
- Develop a risk-based qualification approach and strategy, including FMEA, Risk Assessments, PHA, etc.
- Act as a subject matter expert (SME) at the site to support internal and/or external inspections.
- Manage capital project capex and qualification team budgets and support site cost improvement initiatives.
- Support the development of CQV & CSV policies and procedures to maintain compliance with site, corporate, and regulatory standards.
- 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, particularly 21 CFR part 11, GAMP5, and GMP systems, is required.
- Excellent oral and written communication skills are required.
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