Sr. Engineer - Process Control

Job Description

Job Description

Position Brand Description:

The Process Control Engineer is primarily responsible for the overseeing development and/or configuration of PLC/HMI codes, S88 batch recipe, smart (IIOT) instruments/ devices, historian data, historian reports, data analytics for reliable operation of manufacturing processes, and the existing Process Control systems, the front-line support for Building Management System (BMS), Utility and manufacturing Process Control support for the Celltrion New Jersey Facilities, as applicable. Will work with cross function team to troubleshoot issues for reliable operation of Process Control systems. Will be supporting day to day Process Control activities, developing data analytics tools and reports, driving appropriate GMP change control/deviation, preparing/adhering project schedules, and programming process control systems, as applicable. Will be providing technical support for daily biologics manufacturing operations and for the specification, installation, start-up and validation support of process equipment projects. As applicable, other duties include interfacing with Maintenance, IT, Engineering, and Manufacturing personnel as required to coordinate plant shutdowns, prepare, and review Operational SOP’s and Functional Requirement Specification (FRS), lead projects activities, and represent Process Control group in several process meetings.

Key Objectives/Deliverables:

Manage for Results /Strategic Planning:

1. Be a Subject Matter Expert for overseeing and development of Rockwell Process Control’s PLCs and HMIs codes, S88 batch, OSI PI historian, MS SQL reporting, Thin Manager, data analytics tools (Tableau, Power BI, SAS, etc.), electrical control systems, as applicable.
2. Provide frontline support and troubleshoot PLC and HMI codes, smart instruments and historian data collection systems, as applicable.
3. Managing and working with contractors who develop PLC/HMI/Historian codes, as applicable.
4. Professional experience to work independently with minimum supervision.
5. Deliver professional Process Control and/or Electrical support of clinical and commercial biologics manufacturing operations by:
   1. Representing Engineering on cross functional process teams, possibly for data analytics and reporting, as applicable.
   2. Leading equipment and process troubleshooting efforts, Root Cause Analysis, and deviation, as applicable.
   3. Implementing continuous improvement projects, possibly for data review/monitoring, audit trails, and electrical engineering, as applicable.
6. Interacting regularly with Manufacturing, Maintenance, Process Engineers, Plant Engineering, Validation and Quality and other functions, as needed.
7. Data monitoring and analysis for process improvements and issue resolution for applicable departments.
8. Author, review, and approve change controls, deviation investigations, standard operating procedures (SOPs), drawings, schematics, work orders, etc.
9. Identify Process Control and Data Integrity knowledge gaps that impact equipment and process capability, as applicable.
10. Provide engineering support and project management by:
    1. Maintaining and enhancing the Process Control and Building Management Systems, as applicable.
    2. Developing the project scope, including user requirement, design, functional specifications, and engineering drawings.
    3. Influencing functional groups regarding operability, technical feasibility, engineering design, maintenance, spare parts, installation/shut-down coordination, project schedule and validation/documentation requirements.
    4. Arranging for procurement of equipment and instrumentation required for the projects.
    5. Working with professional consultants and mechanical contractors to develop design and construction drawings/specifications and to implement and test the changes.
    6. Leading installation, start-up, commissioning and qualification activities.
11. On call after hours and weekend support to the Facilities/Manufacturing to ensure continuous production.
12. Keep up to date with required training. Develop expertise by attending technical seminars and training sessions.
13. Grow and develop each year as an individual. Develop deep skills and knowledge. Deliver results consistently.
14. Performs all job functions with adherence to company policies, in a cGMP manner, safely and ethically.
    

Basic Requirements:

1. Demonstrate a deep technical knowledge and experience with Rockwell (PLC/HMI) Process Control Systems, as applicable.
2. Minimum 3 years of experience with AVEVA PI Historian, MS SQL database/ reporting, and Data Analytics tools, as applicable.
3. Have technical knowledge and experience with data analytics tools to monitor manufacturing processes, reduce cost, data integrity (DI) compliance requirements, Electrical distribution, lighting equipment, UPS systems, and emergency generators, as applicable.
4. Have technical knowledge and experience with Process Control Systems, as applicable.
5. Have experience with frontline support in a GMP environment.
6. Strong written and verbal communication skills.
   

Process Control Engineer:

1. 2-5 years experience with Rockwell Automation (PLCs/HMIs), FactoryTalk Batch, and AVEVA PI systems

1. Lead data configuration, analytics and visualization support process monitoring, cost reduction, meet compliance and Data Integrity requirements, as applicable.
2. Demonstrate a deep technical expertise with data monitoring and analytics, as applicable.
3. Have experience with frontline support in a GMP environment.
4. Troubleshoot Process Control issues.
   

Principal Process Control Engineer:

1. 5+ years industrial experience in a cGMP environment.
2. Own the data integrity program supporting manufacturing, maintenance, and engineering.
3. Perform in-depth second tier holistic review including data integrity and technical assessment for Process Control assets. Lead and provide technical expertise on data integrity to site management, as applicable.
4. Coach and mentor front-line Process Control engineers in aspects of fundamental Process Control support including Process Control understanding (both theoretical and practical), problem solving, project management, and Process Control architecture and design.
5. Present and attend various Governance teams as required for technical initiatives and collaborate with other key officials and support groups around the development of process knowledge.
6. Review, approve, and promote documentation of learning points, technical studies, and event investigations, and identify knowledge gaps that impact equipment and process capability.
7. Utilize optimization resources and tools for Process Control assets monitoring and improvement.
8. Provide guidance on key elements of return to service requirements for equipment after interventions, such as maintenance, and in development of test plans for Commissioning and Qualification packages and associated critical components.
9. Support scope development for capital projects targeted at both short and long-term needs and act as user representative in some cases.
10. Relate experiences with troubleshooting bioprocess equipment within area of support (i.e., Bioreactors, chromatography, TFF, CIP, etc.).
11. Champion the application of statistical thinking and use of data to monitor process performance and make engineering decisions.
12. Ensure operational Process Control systems are appropriate and implemented.
13. Support development and technical analysis for large-scale initiatives (secondary loop projects) such as productivity improvements, new product introduction, capacity development, data analysis, data integrity, GMP remediation, and safety and/or environmental risk mitigation.
14. Perform and promote optimization of unit operation cycle time, Process Control system performance, process system improvement through condition/ metering-based monitoring.
15. Proactively work on Life Cycle Management (LCM) of Process Control assets, reliability of Process Control assets, continuous improvement Process Control systems.
16. Provide technical oversight of Asset Qualification Management for Direct Impact systems to ensure constant state of qualification and during development of equipment and process system User Requirements and related Design Review/Qualification documentation to ensure that equipment/systems are appropriate for the intended purpose.
    

Additional Preferences:

1. Possess a passion for understanding, be inquisitive to what is happening in Process Control, Data Analytics, and Electrical, as applicable.
2. Be self-motivated, confident, able to influence and self-directed personality with able to work independently as well as in team environment.
3. Be flexible, resilient, and proactive.
4. Curious to learn new technology.
5. Strong leadership skills, as applicable.

Education Requirements:

1. B.S. or M.S. in Engineering (typically, Chemical, Electronics, Electrical, Computer Engineering.

This role is exempt and the anticipated compensation for this role is $87,000 - $150,000.

This is a banded role, and candidates will be placed within the range based on experience, skills, internal equity, and market considerations.

Celltrion Branchburg, LLC offers a comprehensive benefits package that includes paid time off (holidays, vacation, and additional leave), medical, dental, and vision insurance, life insurance, a company-matched retirement savings plan, wellness programs, and short- and long-term disability benefits. This role requires up to 10% travel, on-call availability, and may involve shift work. Hybrid work flexibility may be available based on business needs; relocation assistance is not provided.

Celltrion Branchburg, LLC is proud to be Equal Opportunity Employer and does not discriminate on the basis of age, race, color, religion, gender, sexual orientation, gender identity or expression, national origin, protected veteran status, disability, or any other legally protected status.