Sr. Automation Engineer Drug Product

U061 (FCRS = US061) Novartis Services, Inc.; Durham (NC); On-site; USD 109,000 - 202,000; Full time

Job summary

Novartis Services, Inc. in Durham, NC is seeking a Senior Automation Engineer to lead the automation design team and act as SME for an Aseptic Drug Product facility, on-site.

The role requires 8+ years GMP pharma experience, strong knowledge of DCS, BMS, PLC, SCADA, and regulatory compliance (21 CFR part 11). Travel up to 10% may be required, with responsibilities spanning project leadership, lifecycle documentation, and continuous improvement.

Qualifications

• BS in Engineering, CS, or related field (required).
• 8 years of GMP pharma manufacturing experience (or 12 years if using equivalent work experience).
• Excellent written and oral communication skills.
• Experience with DCS, BMS, PLC, SCADA, historian, and infrastructure.

Responsibilities

• Lead automation design, commissioning and qualification of new equipment.
• Oversee automation aspects of projects including third-party equipment integration.
• Design, configure, install, and maintain automation software and hardware.
• Prepare scopes of work, lead teams and manage automation contractors.
• Lead discussions with business partners on priorities and timelines.
• Develop and approve URS, FS, and DDS/HDS/SDS lifecycle documentation.
• Develop procedures to meet GMP, CFRs and internal policies.
• Support 24x7 site operations and on-call rotations.
• Assist investigations of automation-related non-conformances.

Skills

DCS

BMS

PLC

SCADA

Instrumentation

FDA CFR 21 Part 11

Project management

Education

B.S. in Engineering or related field

Tools

Kubernetes

Job description

Job Description Summary

The Senior Automation Engineer reports to the AD Process Automation and is responsible for providing automation design team leadership and serving as a technical subject matter expert for a Novartis Aseptic Drug Product facility.

Job Description Location

This position will be located in Durham, NC and will be an On-Site role. Novartis is unable to offer relocation support for this role: please only apply if this location is accessible for you.

Key Responsibilities

• Ensure automation aspects of new equipment are appropriately designed, meet Novartis standards and are appropriately commissioned and qualified.
• Provide oversight for automation aspects of projects including integration of 3rd party equipment to other standard plant systems, e.g., DCS, BMS, Historian, Infrastructure.
• Provide design, configuration, installation, and maintenance of automation software and associated hardware for existing equipment and processes.
• Prepare scopes of work for large projects, lead small teams and manage automation contractors as required to complete required work within project timelines.
• Lead discussions with internal business partners on priorities, timelines and transparent sharing of information.
• Develop, review and approve lifecycle documentation, e.g., User Requirements (URS), Functional Specification (FS) and Detail Design Specifications (DDS/HDS/SDS).
• Develop and 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 including participation in regulatory audits as an automation SME.
• Solve technical related issues impacting production.
• Support 24x7 site-based operations including rotating on-call responsibilities.
• Support investigations of non-conformances related to automation systems.
• 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 various site automation systems including DCS, BMS, PLC, SCADA, historian, infrastructure, including use of various industrial protocols.
• Experience in development and execution of system level qualification 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 writing and executing complex change controls.
• In-depth knowledge of FDA regulations particularly 21 CFR part 11 and GMP systems.
• 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.

Salary Range

Salary Range $108,500.00 - $201,500.00

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 [e-mail] or call [phone] and let us know the nature of your request and your contact information. Please include the job requisition number in your message.

Skills Desired

Api (Application Programming Interface) (Inactive), Api (Application Programming Interface) (Inactive), Automation, Back-End Development, Business Continuity, Change Controls, Chemistry, Design Development, Electronic Components, General Hse Knowledge (Inactive), Including Gdp (Inactive), Java (Programming Language), Knowledge Of Capa (Inactive), Knowledge Of Gmp (Inactive), Kubernetes, Managing Performance Improvement (Inactive), Manufacturing Production, Mathematical Optimization, Project Commissioning, Project Engineering, Project Implementations, React.js, Risk Management, Root Cause Analysis (RCA), Scheduler (Inactive) {+ 2 more}

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