Novartis Group Companies
Site Equipment & CQV Lead
Novartis Group Companies, Indianapolis, Indiana, us, 46262
Job Description Summary
At Advanced Accelerator Applications, a Novartis company, we are committed to leading innovation in nuclear medicine and delivering the next generation of targeted radioligand therapy (RLT) to cancer patients.
Responsible for leading the equipment and CQV engineering team at a GMP Radioligand Therapies Isotope Production Facility. Act as Equipment & CQV Workstream Lead on a major site capital project with responsibility for commissioning, qualification and start-up of the GMP production equipment through to operational readiness. Support operational readiness and continuing manufacturing processes.
Location:
Onsite
Job Description
Team lead of GMP equipment asset owners, managing complete GMP lifecycle from URS through to CQV and placing into operational use.
Manage team of CQV/CSV and Equipment Engineers to maintain equipment reliability and ensuring compliance with all applicable quality and HSE regulations and requirements, both internal & external, for GMP Equipment.
Promotes a strong quality & compliance mindset supporting timely closure of Equipment Engineering & CQV related cGMP deficiencies including audit observations, CAPA's and deviations. Drives pro-active site inspection readiness programs.
Manage capital projects involving equipment upgrades. Manage planning, execution and documentation (URS, FRS, Specifications)
Provide timely reporting to management on progress, priorities, timelines and sharing of necessary information.
Contracts and manages outside vendors and contractors to fulfill business needs.
Authors and/or manages 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 while developing best practices.
Oversee recruitment, training and manage qualified professionals. Coaches, develops, and grows talent of team.
Manages complete CQV & CSV program; from site VMP, compliance with all qualification standards and through to periodic review and ensure validated state is maintained. Develops risk-based qualification approach and strategy (FMEA, Risk Assessments, PHA, etc)
Subject matter expert (SME) at site to support internal and/or external inspections.
Capable of managing capital project capex and qualification team budgets and supports site cost improvement initiatives.
Supports development of CQV & CSV policies and procedures to maintain compliance with site, corporate and regulatory standards.
Support 24x7 site-based operations after startup.
Other related duties as assigned.
Minimum Requirements:
Bachelor's degree in engineering, computer science, automation, or related field is required.
5+ years of relevant engineering experience in 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.
Excellent oral and written communication skills.
5-10% travel
Salary Range:
$124,000.00 - $186,000.00
Skills Desired:
Api (Application Programming Interface), Automation Technology, Change Controls, Chemistry, Design Development, General HSE Knowledge, Java, Knowledge Of CAPA, Knowledge Of GMP, Kubernetes, Managing Performance Improvement, Manufacturing Production, Project Commissioning, Project Engineering, Risk Management, Root Cause Analysis (RCA), Scrum (Programming Methodology).
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At Advanced Accelerator Applications, a Novartis company, we are committed to leading innovation in nuclear medicine and delivering the next generation of targeted radioligand therapy (RLT) to cancer patients.
Responsible for leading the equipment and CQV engineering team at a GMP Radioligand Therapies Isotope Production Facility. Act as Equipment & CQV Workstream Lead on a major site capital project with responsibility for commissioning, qualification and start-up of the GMP production equipment through to operational readiness. Support operational readiness and continuing manufacturing processes.
Location:
Onsite
Job Description
Team lead of GMP equipment asset owners, managing complete GMP lifecycle from URS through to CQV and placing into operational use.
Manage team of CQV/CSV and Equipment Engineers to maintain equipment reliability and ensuring compliance with all applicable quality and HSE regulations and requirements, both internal & external, for GMP Equipment.
Promotes a strong quality & compliance mindset supporting timely closure of Equipment Engineering & CQV related cGMP deficiencies including audit observations, CAPA's and deviations. Drives pro-active site inspection readiness programs.
Manage capital projects involving equipment upgrades. Manage planning, execution and documentation (URS, FRS, Specifications)
Provide timely reporting to management on progress, priorities, timelines and sharing of necessary information.
Contracts and manages outside vendors and contractors to fulfill business needs.
Authors and/or manages 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 while developing best practices.
Oversee recruitment, training and manage qualified professionals. Coaches, develops, and grows talent of team.
Manages complete CQV & CSV program; from site VMP, compliance with all qualification standards and through to periodic review and ensure validated state is maintained. Develops risk-based qualification approach and strategy (FMEA, Risk Assessments, PHA, etc)
Subject matter expert (SME) at site to support internal and/or external inspections.
Capable of managing capital project capex and qualification team budgets and supports site cost improvement initiatives.
Supports development of CQV & CSV policies and procedures to maintain compliance with site, corporate and regulatory standards.
Support 24x7 site-based operations after startup.
Other related duties as assigned.
Minimum Requirements:
Bachelor's degree in engineering, computer science, automation, or related field is required.
5+ years of relevant engineering experience in 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.
Excellent oral and written communication skills.
5-10% travel
Salary Range:
$124,000.00 - $186,000.00
Skills Desired:
Api (Application Programming Interface), Automation Technology, Change Controls, Chemistry, Design Development, General HSE Knowledge, Java, Knowledge Of CAPA, Knowledge Of GMP, Kubernetes, Managing Performance Improvement, Manufacturing Production, Project Commissioning, Project Engineering, Risk Management, Root Cause Analysis (RCA), Scrum (Programming Methodology).
#J-18808-Ljbffr