Job Description SummaryIn 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 DescriptionMajor 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.
Salary Range$93,800.00 - $174,200.00
Skills DesiredBusiness 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
