Validation Engineer III

Key Responsibilities

• Lead commissioning, qualification
• validation activities for manufacturing, laboratory
• utility systems Author, execute
• review validation protocols, reports
• standard operating procedures Oversee user requirement specifications, ensuring compliance, quality
• timely document resolution Perform environmental mapping studies and support specialized validation activities Analyze validation data to confirm accuracy, completeness
• regulatory compliance Develop and support validation strategies and timelines for sustained GMP operations Conduct risk and impact assessments to define system boundaries and validation scope Own validation lifecycle documentation, including plans, assessments
• final reports Support computer systems validation activities for global systems and applications Collaborate with cross-functional teams to support audits, inspections
• project execution Essential Requirements: Bachelor’s or master’s degree in engineering or science with five years of relevant pharmaceutical industry experience Proven experience in validation or engineering within a pharmaceutical or biopharmaceutical environment Strong knowledge of GMP requirements and validation lifecycle stages Hands-on experience with installation, operational
• performance qualification activities Familiarity with global regulatory guidelines, including FDA and International Council for Harmonisation standards Experience performing environmental mapping and using validation tools such as Kaye Validator Experience with biosafety cabinet smoke studies Working knowledge of risk-based validation approaches and industry best practices such as ASTM E2500 and GAMP 5 Excellent technical writing, communication
• problem-solving skills with attention to detail Novartis Compensation and Benefit Summary: The salary for this position is expected to range between $ 98,700 and $183,300 annually.
• The final salary offered is determined based on factors like, but not limited to, relevant skills and experience, and upon joining Novartis will be reviewed periodically.
• Novartis may change the published salary range based on company and market factors.
• Your compensation will include a performance-based cash incentive and, depending on the level of the role, eligibility to be considered for annual equity awards.
• US-based eligible employees will receive a comprehensive benefits package that includes health, life and disability benefits, a 401(k) with company contribution and match, and a variety of other benefits.
• In addition, employees are eligible for a generous time off package including vacation, personal days, holidays and other leaves. #LI-Onsite EEO Statement: The Novartis Group of Companies are Equal Opportunity Employers.
• We do not discriminate in recruitment, hiring, training, promotion or other employment practices for reasons of race, color, religion, sex, national origin, age, sexual orientation, gender identity or expression, marital or veteran status, disability
• any other legally protected status.
• 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
• to perform the essential functions of a position, please send an e-mail to us.reasonableaccommodations@novartis.com or call +1(877)395-2339 and let us know the nature of your request and your contact information.
• Please include the job requisition number in your message.
• Salary Range $98,700.00 - $183,300.00 Skills Desired Business Continuity, Change Control, Cost Management, Data Analytics and Digital, Engineering Technical Expertise, GDP Knowledge, gmp knowledge, HSE Knowledge, Knowledge Of Relevant Tools And Systems , Manufacturing Process (Production), Operational Excellence, Quality Compliance, Resilience and Risk Management, Total Productive Maintenance