Expert, Engineering - Validation & Qualification

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Job description

Imagine… 2 weeks after the birth of your child you realize they aren't meeting critical developmental milestones and after months of doctor's appointments you are told your baby has a rare neurological disease that would impact how they would live their lives. This is the reality of parents whose children have Spinal Muscular Atrophy (SMA) and it's the reason why we at Novartis Gene Therapies are laser focused on bringing hope and possibility to those devastated by rare genetic diseases.

The Expert, Engineering - Validation & Qualification, leads and manages projects and activities that may involve commissioning, qualification, and validation of new or existing equipment/systems, computer system validation, re-qualifications, or utility/facility validation.

Responsibilities

• Develops a tailored approach for each project including; assessing vendor validation packages, performing gap analysis to User Requirements, developing plans and protocols using a risk-based approach that comply with company policies and procedures, and completing trace matrices.
• Manages contract resources or vendors.
• Reports on progress and roadblocks to the project team(s).
• Develops Commissioning and Qualification policies and procedures to enhance the company's ability to conform to and maintain compliance with site, corporate and regulatory standards.
• Development, execution, and management of small to large size projects.
• Authors and/or manages authoring of commissioning, qualification and validation plans, validation protocols, validation summary reports and requirement trace matrices.
• Liaise with client end user groups to ensure correct specification of equipment and utilities.
• Validation using risk-based approach (FMEA, PHA, etc.).
• Performs risk assessments to confirm safe and compliant designs and recommend additional controls.
• Reviews project documentation (URS, FRS, Technical Specifications, Functional Specifications).
• Participates in discussions with internal business partners on priorities, timelines and transparent sharing of information.
• Partners with Quality to ensure a quality and compliant manufacturing environment.
• Other related duties as assigned.

Qualifications

• Bachelor's degree in Engineering, Science or related technical field with 5 years of experience in pharmaceutical or biotechnology GMP manufacturing operations
• 5 years of experience in the design or operation of commercial grade pharmaceutical or biotechnology process equipment and utilities (compressed gas, hoods and cold storage).
• Ability to read/interpret engineering drawings and design documents.
• Excellent technical writing and verbal communication skills.
• Must be people oriented and a team player.
• Proficiency in Microsoft Word, Excel, PowerPoint, Project, and Visio.
• In-depth knowledge of FDA regulations particularly 21 CFR part 11, 210, 211.
• Working knowledge of ICH Q8, Q9, Q10 and other international regulatory requirements.
• Experience managing 3rd parties (both in-sourcing and outsourcing).
• Ability to prepare contingency plans and logically work through complex issues in a high pressure situation.
• 10 - 20% travel.

The level of this position will be based on the final candidate's qualifications.

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!

Novartis Gene Therapies Benefit Summary:

Annual bonus, long term incentive, health insurance, paid vacation/holidays, potential flexible working arrangements (based on role) and an employee recognition program are available for this position, among many other benefits provided to employees of Novartis Gene Therapies.

Please note this job description is not designed to cover or contain a comprehensive listing of activities, duties or responsibilities that are required of the employee for this job. Duties, responsibilities and activities may change at any time with or without notice.

Novartis Gene Therapies is committed to creating a diverse environment and is proud to be an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, gender, gender identity, national origin, genetics, disability, age, sexual orientation or veteran status.

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Accessibility and reasonable accommodations

The Novartis Group of Companies are committed to working with and providing reasonable accommodation to individuals with disabilities. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application process, or in order to perform the essential functions of a position, please send an e-mail to call +1 and let us know the nature of your request and your contact information. Please include the job requisition number in your message.

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