Job Description Summary
In this role, you will work cross‑functionally to support the delivery of capital initiatives, continuous improvements/ upgrades to isolator containment systems, and the implementation of new manufacturing technologies within a GMP-regulated environment. Responsibilities include contributing to project planning, leading assigned workstreams, supporting regulatory compliance, and providing hands-on engineering support from design through execution.Location: Onsite
Job Description
Major accountabilities:
Support internal and external audits.
Prepare project procurement plan, perform project tendering and procurement.
Lead design, installation, qualification, and lifecycle support of Isotopes API manufacturing equipment.
Serve as subject matter expert for new equipment supporting the API expansion capital project.
Own equipment change management to maintain validated state and Good Manufacturing Practice compliance.
Investigate equipment and process deviations, performing root cause analysis and implementing corrective and preventive actions.
Support regulatory inspections and internal audits as engineering subject matter expert.
The salary for this position is expected to range between $93,800 and $174,200 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.
Essential Requirements:
Bachelor’s degree in Chemical, Electrical, or Mechanical Engineering
5+ years of relevant experience with the pharmaceutical industry, or 8+ years of relevant experience within the pharmaceutical industry in lieu of a degree.
Extensive experience supporting API and/or finish drug product manufacturing.
Strong expertise with Hot cells / Isolator Containment systems.
In-depth knowledge of Food and Drug Administration (FDA) regulations and Good Manufacturing Practice (GMP) requirements.
Experience leading equipment qualification, validation strategies, and change management.
Strong technical writing skills for regulated engineering documentation.
Ability to lead cross-functional teams and manage complex capital initiatives.
Excellent communication, organizational, and problem-solving skills.
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 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 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.
Salary Range
$93,800.00 - $174,200.00
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 MaintenanceSkills Required
- Bachelor's degree in Chemical, Electrical, or Mechanical Engineering
- 5+ years of relevant experience in the pharmaceutical industry
- Strong expertise with Hot cells / Isolator Containment systems
- In-depth knowledge of FDA regulations and GMP requirements
- Experience leading equipment qualification and change management
- Strong technical writing skills for regulated engineering documentation
- Ability to lead cross-functional teams
- Excellent communication, organizational, and problem-solving skills
Novartis Compensation & Benefits Highlights
The following summarizes recurring compensation and benefits themes identified from responses generated by popular LLMs to common candidate questions about Novartis and has not been reviewed or approved by Novartis.
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Healthcare Strength — Pay and benefits are described as a strong overall package, supported by medical, dental, and vision insurance alongside FSAs/HSAs and disability and life coverage. Mental-health support is reinforced through an employee assistance program with psychological support and a network of mental health first aiders.
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Retirement Support — Retirement support is positioned as a standout element, with an automatic company contribution plus dollar-for-dollar matching in the 401(k). Additional retirement funding is described through an age-based defined contribution program and access to an employee share purchase plan discount.
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Parental & Family Support — Family-related benefits are framed as robust, including a global minimum of paid parental leave for new parents following birth or adoption. Added supports include domestic partner coverage, dependent-care resources, and benefits such as adoption assistance and child/elder care options.
Novartis Insights
What We Do
Novartis is an innovative medicines company. Every day, working to reimagine medicine to improve and extend people’s lives so that patients, healthcare professionals and societies are empowered in the face of serious disease. Our medicines reach more than 250 million people worldwide.
