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Validation Lead Full-time

at Novartis in New Jersey (Published at 16-01-2020)

750 million. That?s how many lives our products touch. And while we?re proud of that fact, in this world of digital and technological transformation, we must also ask ourselves this: how can we continue to improve and extend even more people?s lives?
We believe the answers are found when curious, courageous and collaborative people like you are brought together in an inspiring environment. Where you?re given opportunities to explore the power of digital and data. Where you?re empowered to risk failure by taking smart risks, and where you?re surrounded by people who share your determination to tackle the world?s toughest medical challenges.
The Novartis Cell & Gene Therapy team is seeking a Validation Lead in East Hanover, NJ.
What you?ll be doing
Responsible for developing, performing, implementing and managing ? supported by Engineers and Process Experts (Head Manufacturing and Cell Processing Specialist) - the Site aseptic, process and cleaning validation, shipping validation and revalidation strategies to meet cGMP requirements to ensure that programs are compliant with Novartis and Regulatory requirements and related SOPs
Your responsibilities will include, but not limited to:

  • Establish, write, maintain Validation Master Plan (VMP) for manufacturing process, aseptic process, cleaning, and shipping validation
  • Support Site Head in ensuring that the VMP activities including, annual revalidation process simulation procedures are executed and maintained as defined in VMP
  • Maintain overview of state of validation at Site and establish the validation project prioritization across site.
  • Establish and manage the respective validation plans by aligning, coordinating and supervising the prioritization of activities against the business needs.
  • Review risk assessments for validation.
  • Set local procedures & templates for respective validation documentation and validation master plan, provide guidance to facility impact and component criticality assessments.
  • Partner with Quality based on feedback (e.g. via division, regulatory inspections, changes in regulations) to establish and maintain common approach and translate that for the site
  • Partner with the Production, Warehouse, Engineering, and IT to define the process validation/ shipping/equipment/systems qualification interface.
  • Identify with Development, Production, and QA critical process parameters for clinical batch production and ensure that the data is monitored and analyzed (provide a tool)
  • Once it is necessary, develop the strategy for Continued Process Verification (CPV) that ensures all critical process parameters and quality attributes are defined (in collaboration with QA and Development), monitored or analyzed, and actions taken in case of trends or deviations.
  • Review risk assessments for CPV.
  • Ensure CPV plans are in place to monitor and trend critical process parameters, quality attributes.
  • Maintain all activities in an inspection ready status ahead of any internal or external audits to ensure successful inspections e.g. no critical observations related to validation activities.
  • 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.
  • Responsible for translating the critical process parameters and the process control strategy into a focused validation plan for process validation.

What you?ll bring to the role:
  • Validation approach meets Novartis QM requirements, health authority and industry standards.
  • Validation/annual monitoring/revalidation activities scheduled in a timely manner that do not adversely impact production schedule nor audit readiness.
  • Validation Master Plan (VMP) completed and up to date.
  • Product maintained in a constant state of validation.
  • Meet established validation and revalidation milestones according to approved validation plans.
  • No critical observations during audits/inspections, products maintained in constant state of validation.
  • Transfers/launches implemented on schedule and on target without validation related issues. Deliver validation data that meet the target schedule and quality to support the required registration documentation.
  • Training curriculum up-to-date

https://www.youtube.com/watch?v=Mo1vwtVPVA0

EEO Statement

The Novartis Group of Companies are Equal Opportunity Employers and take pride in maintaining a diverse environment. We do not discriminate in recruitment, hiring, training, promotion or any other employment practices for reasons of race, color, religion, gender, national origin, age, sexual orientation, marital or veteran status, disability, or any other legally protected status.

Minimum requirements

  • BSc./MS in Biotechnology or relates science or Pharmaceutical Technology.
  • A minimum of 8 years of experience in pharmaceutical Manufacturing, Manufacturing Science & Technology, Technical Development or Quality with 5-7 years of experience in executing process validation, having led and managed validation projects.
  • Proven process understanding (Pharma, GMP, Regulatory aspects).
  • Cell and Gene Therapy and/or Aseptic processing experience preferred.
  • Thorough understanding of manufacturing processes and related process equipment.
  • Strong working knowledge of applied statistics, quality systems and regulatory requirements across multiple health authorities.
  • Sound experience of data handling and applied statistics is a must.
  • Proven project management experience in a cross-functional environment (e.g. multi-site, technical development, other functions).
  • Fundamental understanding of standard pharmaceutical analytical testing.
  • Strong leadership and interpersonal skills as well as excellent presentation and scientific/technical writing skills

What Novartis can offer you?
Yes, we offer exceptional benefits and competitive salaries. However, we can offer more. Here you will:
  • Work on interdisciplinary projects with a wide range of business functions and successfully work in global cross-functional matrix.
  • A clear sense of personal accountability, an ability to empower people, ability to drive quality culture with partners and a high degree of mutual respect and integrity are essential factors to succeed.
  • Innovative, analytical, conceptual & solution-oriented mindset.
  • An organization with strong customer focus and quality driven
  • Work with the latest technologies
  • Work with industry thought leaders on a regular basis

We are Novartis. Join us and help us reimagine medicine.

Division

Novartis Technical Operations

Business Unit

NTO CELL & GENE THERAPY

Country

USA

Work Location

East Hanover, NJ

Company/Legal Entity

Novartis Pharmaceuticals

Functional Area

Technical Operations

Job Type

Full Time

Employment Type

Regular


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