Validation Lead

Oct 08, 2021

Job Description

Why Novartis?

769 million lives were touched by Novartis medicines in 2020, and while we’re proud of this, we know there is so much more we could do to help improve and extend people’s lives.
We believe new insights, perspectives and ground-breaking solutions can be found at the intersection of medical science and digital innovation. That a diverse, equitable and inclusive environment inspires new ways of working.
We believe our potential can thrive and grow in an unbossed culture underpinned by integrity, curiosity and flexibility. And we can reinvent what's possible, when we collaborate with courage to aggressively and ambitiously tackle the world’s toughest medical challenges. Because the greatest risk in life, is the risk of never trying!
Imagine what you could do here at Novartis!

Job Purpose (State in one sentence the overall objective of the job)

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.

Major Accountabilities (Describe the main results of the job to be achieved )

Validation Master Plan
• 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.

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.
• Generate all FMEAs, validation/re-validation protocols and reports, review Master Batch Records (MBRs), associated change controls and support the execution at the shop floor.
• Look for improvement to simplify aseptic/process validation activities
• Participate in transfers and launches, liaise with Development for new products and align on the product validation approach. Contribute to provide experimental data obtained during the validation activities, which will be used to prepare the related registration documentation.
• Provide input to Quality Manuals (QM)/Quality Directives (QD)/global Standard Operating Procedures (SOPs) and Technical Guidance Documents (TGDs) to ensure documents are in line with global/local requirements and industry standards.
• Participate in improvement and remediation of products.
• Be a senior advisor and ensure regular exchange with other Cell & Gene sites as well as Global MS&T organization and Quality Compliance
• Understand potential risk areas/shortfalls and make sure that the site validation program is always inspection ready.
• Ensure a proper prioritization approach for High Level Product Assessments, product validation, compliance activities.
• Own the Training Curriculum for Validation and support the Site Head in defining the Operator Qualification program and process training
Change control:
• Participate in the change controls of products and related processes.
• Ensure alignment of (regulatory) timelines for technical changes (e.g. DS), transfers or launch, major deviations.
• Initiate, manage and lead change requests related to process changes
• Provide all data related to validation and review submission documents
• Own the Training Curriculum for its Job Profile and provides the necessary training and support to new associates joining this position.
• Responsible for proper Knowledge Management throughout the local organization
Audit support:
• Maintain work in an inspection-ready level and provide the necessary support in any internal or external audit.

Key Performance Indicators (Indicate how performance will be measured: indicators, activities…)

• 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.

Diversity & Inclusion / EEO

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 other employment practices for reasons of race, color, religion, gender, national origin, age, sexual orientation, gender identity or expression, marital or veteran status, disability, or any other legally protected status. We are committed to building diverse teams, representative of the patients and communities we serve, and we strive to create an inclusive workplace that cultivates bold innovation through collaboration and empowers our people to unleash their full potential.

Minimum Requirements

Education: BS/MS in Biotechnology or related science or Pharmaceutical Technology.

Languages: Fluent in speaking / writing in English

• 8+ years of experience in pharmaceutical Manufacturing, Manufacturing Science & Technoogy, Technical Development or Quality with 5+ 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

Other Qualifications:
• Strong interpersonal communication skills along with problem solving mindset are required.
• Must be well organized, flexible and work with minimal supervision.

Commitment to Diversity & Inclusion:
Novartis is committed to building an outstanding, inclusive work environment and diverse team’s representative of the patients and communities we serve.

Join our Novartis Network: If this role is not suitable to your experience or career goals but you wish to stay connected to hear more about Novartis and our career opportunities, join the Novartis Network here:
Global Drug Development
East Hanover, NJ
Technical Operations
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Validation Lead

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