摘要
The Validation Engineer will execute and manage process, primary packaging, and cleaning validation activities and change management activities to meet cGMP requirements on time and quality to ensure that site validation programs are compliant with global regulatory expections.
About the Role
Responsibilities:
- Supports the development of Validation/Qualification documents including drafting risk assessments, qualification protocols, deviations, and reports. Supports the execution of validation/qualification activities for the site (including manufacturing equipment, QC lab equipment, utilities).
- Reviews, evaluates and analyzes validation data for accuracy and adequacy.
- Supports the validation execution strategy and timeline for sustained commercial and clinical operations within a validation GMP environment.
- Assists with change management validation impact assessments.
- Supports the site validation periodic re-evaluation program including periodic reviews and requalifications.
- Assists with Validation lifecycle documents.
- Manages workload to ensure timely approval of validation testing and documentation.
- Supports the validation department during inspections or audits.
- Other related duties as assigned.
The salary for this position is expected to range between $63,600 and $118,200 per year.
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.
Minimum Requirements:
- BS/MS degree in Chemical, Industrial, Mechanical, or other related engineering/science discipline with a minimum of 2 years of relevant engineering experience in the pharmaceutical or Biopharmaceutical industry.
- Familiarity with good engineering practices, validation tools and processes, risk management, GAMP 5 applications and practices (including environmental mapping and use of Thermal Mapping equipment is preferred).
- Experience in cGMP environment (IQ, OQ, PQ).
- Familiar with current industry best practices, including ASTM e2500 to plan efficient/risk-based validation projects.
- Strong technical writing and verbal communication skills.
- Proficient in Microsoft Word, Excel, PowerPoint, and Project.
Why Novartis: Helping people with disease and their families takes more than innovative science. It takes a community of smart, passionate people like you. Collaborating, supporting and inspiring each other. Combining to achieve breakthroughs that change patients’ lives. Ready to create a brighter future together? https://www.novartis.com/about/strategy/people-and-culture
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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, or any other legally protected status.
Accessibility & 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 to perform the essential functions of a position, please send an e-mail to [email protected] 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.
