Engineering support for automation systems, interfaces and equipment. Responsible for oversight of the automation systems across the facility (building/process/laboratory). Ensures the site's compliance with internal GMP’s, CSV and external regulatory requirements.
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
• Oversight of the automation systems at the site including building automation systems (BAS), room monitoring systems (RMS), process and laboratory equipment automation.
• Oversight of the overall automation asset care strategy for the site which includes performing upgrades, maintenance contracts and changes.
• Responsible for the support and execution of automation qualification as well as the resolution of all automation-related issues.
• Ensure cGMP, Data Integrity, and CSV compliance with all internal Novartis and external regulatory requirements.
• 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 manufacturing, engineering, utility operations, maintenance, quality assurance, and qualification to manage a diverse portfolio of projects.
• Lead, plan, and execute automation projects from start-up to completion.
• Develop Project Commission Plan / Strategy.
• Manage and resolve project deficiencies and deviations.
• Develop project execution strategy and execute project(s) according to customer needs (costs, schedule, functionality, quality).
• Assist in Preparing Project Initiation Documents (Business Requirements (PBR), Work Breakdown Structure (WBS); Cost Breakdown Structure (CBS), Project Scope Statement (PSS).
• Provide technical support to operations and support personnel.
• Own and close corrective actions related to the automation systems.
• Compliance with technical, quality and legal requirements.
• Reliable runtime of automation systems (minimum downtime).
Minimum Qualifications:
• Bachelor’s degree in engineering, computer science, automation, or related field or equivalent relevant experience
• 2+ years of relevant engineering experience in Chemical, Pharmaceutical or Food & Beverage industry is required
• Good oral and written communication skills.
• Knowledge of FDA regulations, particularly 21 CFR part 11 and GMP systems.
• Familiarity with industry standards 21 CFR Part 11, Data Integrity, Validation, and GAMP. Must be able to work in controlled environments requiring special gowning.
• Extended interdisciplinary technical knowledge. Knowledgeable in a GMP regulated environment (pharmaceutical preferable).
• Experience with automation systems (Continuum, Siemens, DeltaV, PLCs, etc). Knowledge of IT infrastructure/networks related to automation systems. Strong oral and written communication skills.
• Must be able to work well with others in a team environment. Strong computer skills.
• Working knowledge of P&ID and loop diagram standards; temperature, pressure, flow, weight, humidity, and other instrumentation.
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!
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?
Join our Novartis Network: Not the right Novartis role for you? Sign up to our talent community to stay connected and learn about suitable career opportunities as soon as they come up:
Benefits and Rewards: Read our handbook to learn about all the ways we’ll help you thrive personally and professionally:
EEO Statement:
The Novartis Group of Companies are Equal Opportunity Employers who are focused on building and advancing a culture of inclusion that values and celebrates individual differences, uniqueness, backgrounds and perspectives. 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. We are committed to fostering a diverse and inclusive workplace that reflects the world around us and connects us to the patients, customers and communities we serve.
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.
About Us: Hidden Talent Bee is a premier agency specializing in adult modeling, dedicated to celebrating and showcasing diverse and bold forms of expression. We are a dynamic team passionate about pushing boundaries and redefining beauty standards in the adult industry...
...Job Posting: Coffee Methodologist (Barista) Wake Coffee Location: 133 S Main Street Ambler, PA 19002 Position: Full-Time / Part-Time Wake Coffee isnt your typical coffee shopwere redefining the craft of coffee. Inspired by the precision and artistry of...
...looking for a detail-oriented and organized Office Assistant to join our administrative team. In this... ...communication skills. Ability to work independently and as part of a team in a... ...) Training & Development Work From Home Employment Type: Full-Time Salary:...
...Description: Sonoran Sun Pediatric Therapy is seeking a highly motivated and passionate fully licensed and certified Pediatric Physical Therapist (PT) in Arizona. This role is for a full-time Physical Therapist. Sonoran Sun Pediatric Therapy provides Speech Therapy...
...self-starters who are eager to learn, earn, and advance professionally in an ever-growing industry. Our client is in search of a Freight Broker / Transportation Sales Rep to join their ever-growing team. In this role, you will contact trucking companies and carriers to...