Job Description Summary
The Senior Automation Engineer reports to the Site ITOT Head and is responsible for providing automation design team leadership and serving as a technical subject matter expert for a Novartis gene therapy manufacturing facility. This includes responsibilities for maintaining, troubleshooting, and modifying the GMP and non-GMP control systems. Systems include plant wide DCS (DeltaV), BMS (Rockwell SCADA) and 3rd party local control systems.
Job Description
Location:
- This position will be located in Durham, NC and will be an onsite role.
- Novartis is unable to offer relocation support for this role: please only apply if this location is accessible for you.
Key Responsibilities:
- Provide design, configuration, installation, and maintenance of automation software and associated hardware; including interacting with other teams as necessary.
- Provide oversight or participation on automation aspects of future projects including integration of 3rd party equipment to the plant DCS and BMS systems, data concentration, batch reporting, and data retention.
- Prepare scopes of work for large projects and manage automation contractors as required to complete required work within project timelines.
- Develop project objectives working with user requirements and business plans.
- Determine equipment or system specifications and most cost-effective technology to be implemented.
- Lead discussions with internal business partners on priorities, timelines and transparent sharing of information.
- Establish equipment specifications in standard documentation – User Requirements (URS), Functional Specification (FS) and Detail Design Specifications (DDS/HDS/SDS).
- Take programs from concept thru execution while managing all stages in the process utilizing a strong set of project management tools.
- Maintain procedures to meet GMP requirements, CFR’s and internal company policies.
- Participate and/or lead new product implementation processes to ensure smooth transition from process development into GMP manufacturing.
- Drive operational excellence and continuous improvement.
- Partner with Quality to ensure a quality and compliant manufacturing environment.
- Problem solve any technical related issues impacting production.
- Support 24x7 site-based operations including rotating on-call responsibilities.
- Create and update procedures to drive operational efficiency and compliance.
- Implement and revise SOPs to conform with standards and policies.
- Deploy, maintain, and upgrade manufacturing applications.
- Perform investigations of non-conformances related to automation systems.
- Analyze and interpret data, and make sound technical recommendations on continuous improvements and non-conformance remediations.
- Execute change controls to update and upgrade automation systems and equipment.
- Other related duties as assigned.
Essential Requirements:
- B.S. degree in Engineering, Computer Science, or related technical field.
- 8 years work experience in pharmaceutical or biopharmaceutical based GMP manufacturing operations, or equivalent work experience (12 years) in pharmaceutical or biopharmaceutical based GMP manufacturing operations.
- Excellent oral and written communication skills, including demonstrated technical writing skills.
- Experience programming, troubleshooting, and maintaining site DCS systems, preferably DeltaV.
- Experience programming, troubleshooting, and maintaining site SCADA/HMI systems, preferably Rockwell FactoryTalk View SE.
- Experience programming, troubleshooting, and maintaining site PLC/BMS systems, preferably Allen Bradley CompacLogix/ControlLogix.
- Experience programming, troubleshooting, and maintaining site data historian, preferably OSI PI.
- Experience configuring and maintaining Statistical Analysis packages, preferably Statistica.
- Experience configuring and maintaining MES, preferably OpsTrakker.
- Experience in development and execution of system level validation testing including providing guidance on qualification plans in conjunction with C&Q department.
- Proven experience applying S88 in an automated environment and development of control system standards aligning with S88 methodology.
- Experience in field wiring practices and panel design, experience with troubleshooting and start-up of control systems, and experience with instrumentation.
- Experience in using industrial communication protocols such as MODBUS, Ethernet IP, etc.
- Experience writing and executing complex change controls.
- Able to develop MS SQL queries and utilize queries to help streamline periodic reviews and other automation tasks.
- In-depth knowledge of FDA regulations particularly 21 CFR part 11 and GMP systems.
- Applied knowledge of Quality by Design, six-sigma, and operational excellence tools in creating efficient and high quality processes and end products.
- Experience managing 3rd parties (both in-sourcing and outsourcing).
- Strong project management skill set with extensive experience in strategic / tactical planning, demonstrated ability to perform long-term project planning.
- Ability to prepare contingency plans and logically work through complex issues in a pressure filled atmosphere.
- Provide technical support on all manufacturing issues when driving towards issue resolution.
- Up to 10% travel may be required.
Novartis Compensation and Benefit Summary:
The salary for this position is expected to range between $108,500 and $201,500 annually
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.
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EEO Statement:
The Novartis Group of Companies are Equal Opportunity Employers. 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.
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 to perform the essential functions of a position, please send an e-mail to us.reasonableaccommodations@novartis.com 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.
Salary Range
$108,500.00 - $201,500.00
Skills Desired
Business Continuity, Cost Management, Data Analytics and Digital, Decision Making, Engineering Operations Management, Engineering Technical Expertise, GDP Knowledge, gmp knowledge, HSE Knowledge, Manufacturing Process (Production), Operational Excellence, Problem Solving, Project Management, Quality Compliance, Resilience and Risk Management, Resource Planning and Forecasting, Risk Management, Stakeholder Management, Vendor Management