• Job Description

  Req#: 380508BR
  Advanced Accelerator Applications, a Novartis company, is an innovative medicines company focused on the development of products for targeted radioligand therapy and precision radioligand imaging. We are committed to transforming patients’ lives by leading innovation in nuclear medicine.
  
  Advanced Accelerator Applications offers professionals the opportunity to face new challenges and pursue a career in a fast growing, technology driven healthcare company. We are passionate about improving patient health by leading innovation in nuclear medicine. We are looking for people who share our commitment to help us achieve this goal. Advanced Accelerator Applications is an Equal Opportunity Employer (EOE).
  
  Location: On-site
  
  The Validation Lead is responsible for developing, implementing and managing the site process validation, primary packaging validation, cleaning validation and revalidation strategies to meet cGMP and quality requirements on time and on budget to ensure that programs are aligned with Regulatory Authorities’ expectations and related SOPs.
  
  Stewardship:
  • Support Product Steward in maintaining the process control strategy.
  • Provide technical expertise and facilitate establishment of Quality Risk Assessment (as needed).
  
  Validation:
  • Define and implement validation strategy (process, cleaning, ongoing verification) and defend to authorities.
  • Overall responsibility for establishment, prioritization, execution and tracking of Validation Master Plan for process, cleaning, packaging validation and ongoing process verification (OPV), ongoing cleaning verification.
  • Ensure that all manufacturing and cleaning processes are validated, overview on state of validation at site is maintained.
  • Establish and monitor validation critical metrics.
  • Maintain all validation activities in an inspection ready status.
  • Reviews risk assessments for validation and OPV, provide guidance to facility impact and component criticality assessments.
  • Author complex validation protocols.
  • Establish local procedures & templates for respective validation documentation.
  • Ensure that all Site validation activities are performed and are in line with the current Novartis requirements and cGMP, handling any deviations associated to these activities including oversight of pre-validation and validation resulting from technical changes.
  • Provide technical expertise (and may facilitate) pre-validation risk assessments using risk management tools.
  • Be a senior advisor in case of difficult validation challenges at Site.
  • Host validation council.
  • Support Site MS&T Head in ensuring that responsible departments execute and maintain the VMP activities.
  • Partner with Engineering, IT, QC, AS&T to define the interfaces to equipment qualification / utilities qualification, system qualification, analytical method validation.
  
  Launch & Transfer:
  • Participate in transfers and launches, liaise with technical development for new products and align on the product validation approach. Provide technical expertise for pre-validation / validation strategy.
  • Contribute to providing experimental data obtained during the validation activities, which will be used to prepare the related registration documentation.
  
  Training:
  • Own the Training Curriculum for own Profile and direct reports.
  
  Novartis Manufacturing Manual:
  • Support implementation of Novartis Manufacturing Manual principle 3.
  • Represent site in validation network.
  
  The pay range for this position at commencement of employment is expected to be between $118,400 and $177,600 per year; however, base pay offered may vary depending on multiple individualized factors, including market location, job-related knowledge, skills, and experience. The total compensation package for this position may also include other elements, including a sign-on bonus, restricted stock units, and discretionary awards in addition to a full range of medical, financial, and/or other benefits (including 401(k) eligibility and various paid time off benefits, such as vacation, sick time, and parental leave), dependent on the position offered. Details of participation in these benefit plans will be provided if an employee receives an offer of employment. If hired, employee will be in an “at-will position” and the Company reserves the right to modify base salary (as well as any other discretionary payment or compensation program) at any time, including for reasons related to individual performance, Company or individual department/team performance, and market factors.
  
  

• About the company

  At Novartis, we are reimagining medicine to improve and extend people’s lives. We are working hard to produce breakthroughs and address unmet needs for patients with devastating diseases, including genetic disorders and certain deadly cancers. Learn mo...

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