Overview:
2 weeks after the birth of your child, imagine you realize they aren’t meeting critical developmental milestones and after months of doctor’s appointments you are told your baby has a rare neurological disease that would impact how they would live their lives. This is the reality of parents whose children have Spinal Muscular Atrophy (SMA) and it’s the reason why we at Novartis Gene Therapies are laser focused on bringing hope and possibility to those devastated by rare genetic diseases.
The Automation Engineer II is responsible for participating on automation design teams and supporting specific systems for a Novartis gene therapy manufacturing facility. Systems include plant wide DCS (DeltaV), BMS (Rockwell SCADA) and 3rd party local control systems.
Responsibilities:
- Helps to maintain, troubleshoot, and modify the GMP and non-GMP control systems.
- Participates in the design, configuration, installation, and maintenance of automation software and associated hardware, including interacting with other teams as necessary.
- Participates on automation aspects of future projects including modification of plant DCS and BMS systems.
- Prepares scopes of work for small to medium sized automation projects.
- Develops project objectives working with user requirements and business plans.
- Participates in discussions with internal business partners on priorities, timelines, and transparent sharing of information.
- Develops/updates equipment specifications in standard documentation – User Requirements (URS), Functional Specification (FS) and Detail Design Specifications (DDS/HDS/SDS).
- Maintains procedures to meet GMP requirements, CFR’s and internal company policies.
- Supports control system changes necessary for new product implementation.
- Supports operational excellence and continuous improvement.
- Partners with Quality to ensure a quality and compliant manufacturing environment.
- Problem solves technical related issues impacting production.
- Supports 24x7 site-based operations including rotating on-call responsibilities.
- Updates procedures to drive operational efficiency and compliance.
- Revises SOPs to conform with standards and policies.
- Supports deployment, maintenance, and upgrading of manufacturing applications.
- Supports investigations of non-conformances related to automation systems.
- Executes automation aspects of change controls.
- Other related duties as assigned.
Qualifications:
- Bachelor's degree in Engineering, Computer Science, or related technical field.
- 2 years’ work experience in pharmaceutical or biopharmaceutical based GMP manufacturing operations, or 6 years equivalent work experience.
- Excellent oral and written communication skills.
- Working in a team environment, with excellent communication and organizational skills.
- Ability to work on problems of moderate scope where analysis of situations or data requires a review of a variety of factors.
- Exercises judgment within defined procedures and practices to determine appropriate action.
- Builds productive internal/external working relationships.
- Experience programming PLC and/or DCS systems and troubleshooting equipment utilizing these systems. DeltaV DCS and Rockwell PLC experience preferred.
- Experience in executing test protocols for automation system level commissioning and qualification.
- Experience executing change controls in change management systems.
- Experience troubleshooting and providing support for manufacturing issues
- Working knowledge of field device signal wiring practices and panel design, experience with troubleshooting and start-up of control systems, and familiarity with instrumentation.
- Familiarity with industrial communication protocols such as MODBUS, Ethernet IP, etc.
- Familiarity with FDA regulations particularly 21 CFR part 11 and GMP systems.
Please note this job description is not designed to cover or contain a comprehensive listing of activities, duties or responsibilities that are required of the employee for this job. Duties, responsibilities and activities may change at any time with or without notice. The level of this position is GJFA 7
Why Novartis?
236 million lives were touched by Novartis medicines in 2022, and while we’re proud of this, we know there is so much more we could do to help improve and extend people’s lives. We believe new insights, perspectives and ground-breaking 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 is committed to building an outstanding, inclusive work environment and diverse teams representative of the patients and communities we serve. Additionally, Novartis Gene Therapies is committed to creating a diverse environment and is proud to be an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, gender, gender identity, national origin, genetics, disability, age, sexual orientation or veteran 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 in order to perform the essential functions of a position, please send an e-mail to tas.nacomms@novartis.com 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.
The pay range for this position at commencement of employment is expected to be between $80,000 - $120,000 annual; 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.
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