Sr Project Engineer

Responsibilities Support cross‑functionally to deliver capital initiatives, continuous improvements/upgrades to isolator containment systems, and implementation of new manufacturing technologies within a GMP‑regulated environment. Contribute to project planning, lead assigned workstreams, support regulatory compliance, and provide hands‑on engineering support from design through execution. 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, perform root cause analysis, and implement corrective and preventive actions. Support regulatory inspections and internal audits as engineering subject matter expert. Qualifications Bachelor’s degree in Chemical, Electrical, or Mechanical Engineering. 5+ years of relevant experience with the pharmaceutical industry (or 8+ years in lieu of a degree). Extensive experience supporting API and/or finished drug product manufacturing. Strong expertise with Hot cells / Isolator Containment systems. In‑depth knowledge of FDA regulations and 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. Location: Onsite 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 such as relevant skills and experience, and upon joining Novartis it 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. Employees are also eligible for a generous time‑off package including vacation, personal days, holidays and other leaves. #J-18808-Ljbffr Novartis Farmacéutica