Location: Indianapolis,IN, USA
Summary
The Senior Automation Engineer supports automation systems, interfaces and equipment. Responsible for management of the automation systems across the facility (building/process/laboratory). Ensures the site's compliance with internal GMP's, CSV and external regulatory requirements.
About the Role
At Advanced Accelerator Applications, a Novartis company, we are committed to leading innovation in nuclear medicine and delivering the next generation of targeted radioligand therapy to cancer patients. We are looking for experienced Supply Chain professionals to help us reach our ambitious goals.
Location: Onsite
* Management of the automation systems at the site including building management systems (BMS), room monitoring systems (EMS), process and laboratory equipment automation.
* Manage the overall automation asset care strategy for the site including upgrades, maintenance contracts and changes.
* Responsible for the management, support and execution of automation qualification as well as the resolution of all automation-related issues.
* Update and develop User Requirement Specifications, Functional Specifications, Design Specifications, Operation and Maintenance for the new and existing control systems.
* Devise new approaches to complex problems through adaptations and modifications of standard automation technical principles.
* Work closely with multiple disciplines, including manufacturing, engineering, utility operations, maintenance, quality assurance, and qualification to manage a diverse portfolio of projects.
* Manage resources to plan, develop, and execute automation projects from start-up to completion.
* Establish, monitor, and maintain a stable and productive automation environment through oversight, preventative maintenance, and standard operating procedures.
* Manage and oversee project work plans, meetings, decisions, project deliverables, progress reports, schedules, cost tracking and other pertinent reports.
* Provide and/or coordinate vendor training to new users of automation systems.
* Ensure cGMP and CSV compliance with all internal Novartis and external regulatory requirements.
* Work collaboratively to address data integrity issues.
* Initiate and execute change control activities for automation systems.
* System/Application owner for automation systems interfacing with IT on server, network and infrastructure.
* Manage resources (external) for providing technical support to operations and support personnel.
* Own and close corrective actions related to automation systems.
Minimum Requirements:
* Bachelor's degree in engineering, computer science, automation, or related field with 7+ years of relevant engineering experience in Chemical or Pharmaceutical industry or 10+ years relevant engineering experience in lieu of a degree.
* Good oral and written communication skills.
* Knowledge of FDA regulations, particularly 21 CFR part 11 and GMP systems.
* Shows the appropriate sense of urgency around given tasks.
* Pharmaceutical based GMP manufacturing operations including aseptic fill/finish and/or radio pharmacy is preferred.
* Training in radiochemistry or radio pharmacy is preferred.
* Radiation safety education is preferred.
The pay range for this position at commencement of employment is expected to be between $124,000 and $186,000 per year; however, base pay offered may vary depending on multiple individualized factors, including market location, job-related knowledge, skills, and experience. The total compensation package for this position may also include other elements, including a sign-on bonus, restricted stock units, and discretionary awards in addition to a full range of medical, financial, and/or other benefits (including 401(k) eligibility and various paid time off benefits, such as vacation, sick time, and parental leave), dependent on the position offered. Details of participation in these benefit plans will be provided if an employee receives an offer of employment. If hired, employee will be in an at-will position and the Company reserves the right to modify base salary (as well as any other discretionary payment or compensation program) at any time, including for reasons related to individual performance, Company or individual department/team performance, and market factors.
Why Advanced Accelerator Applications?
Thousands of people die of cancer around the world every day. At Advanced Accelerator Applications, a Novartis company, our mission is to transform lives through radioligand therapy in nuclear medicine to fight several leading types of cancer. How will we continue to be on the cutting edge of medicine? We believe new groundbreaking solutions can be found at the intersection of medical science and digital innovation. That a diverse, equitable and inclusive environment inspires new ways of working. We believe our potential can thrive and grow in an unbossed culture underpinned by integrity, curiosity and flexibility. And we can reinvent what's possible, when we collaborate with courage to aggressively and ambitiously tackle the world's toughest medical challenges. Because the greatest risk in life, is the risk of never trying! Imagine what you could do here at Novartis!
Commitment to Diversity & Inclusion:
Novartis embraces diversity, equal opportunity, and inclusion. We are committed to building diverse teams, representative of the patients and communities we serve, and we strive to create an inclusive workplace that cultivates bold innovation through collaboration and empowers our people to unleash their full potential.
Join our Novartis Network: If this role is not suitable to your experience or career goals but you wish to stay connected to learn more about Novartis and our career opportunities, join the Novartis Network here:
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?