Sr. Engineer - Process Control

Celltrion Branchburg, LLC•Branchburg Township, NJ

3d•$87,000 - $150,000•Hybrid

About The Position

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. This role provides front-line support for Building Management System (BMS), Utility and manufacturing Process Control support for the Celltrion New Jersey Facilities. The engineer will collaborate with cross-functional teams to troubleshoot issues for reliable operation of Process Control systems. Responsibilities include 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. The role also involves providing technical support for daily biologics manufacturing operations and for the specification, installation, start-up, and validation support of process equipment projects. Other duties include interfacing with Maintenance, IT, Engineering, and Manufacturing personnel to coordinate plant shutdowns, prepare and review Operational SOP’s and Functional Requirement Specification (FRS), lead project activities, and represent the Process Control group in process meetings.

Requirements

Deep technical knowledge and experience with Rockwell (PLC/HMI) Process Control Systems.
Minimum 3 years of experience with AVEVA PI Historian, MS SQL database/reporting, and Data Analytics tools.
Technical knowledge and experience with data analytics tools to monitor manufacturing processes, reduce cost, and ensure data integrity (DI) compliance requirements.
Technical knowledge and experience with Process Control Systems.
Experience with frontline support in a GMP environment.
Strong written and verbal communication skills.
2-5 years experience with Rockwell Automation (PLCs/HMIs), FactoryTalk Batch, and AVEVA PI systems.
Lead data configuration, analytics and visualization support for process monitoring, cost reduction, and compliance and Data Integrity requirements.
Deep technical expertise with data monitoring and analytics.
Troubleshoot Process Control issues.
5+ years industrial experience in a cGMP environment.
Experience with troubleshooting bioprocess equipment within area of support (i.e., Bioreactors, chromatography, TFF, CIP, etc.).
B.S. or M.S. in Engineering (typically, Chemical, Electronics, Electrical, Computer Engineering).

Nice To Haves

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

Responsibilities

Oversee and develop 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.), and electrical control systems.
Provide frontline support and troubleshoot PLC and HMI codes, smart instruments, and historian data collection systems.
Manage and work with contractors developing PLC/HMI/Historian codes.
Represent Engineering on cross-functional process teams, including data analytics and reporting.
Lead equipment and process troubleshooting efforts, Root Cause Analysis, and deviation management.
Implement continuous improvement projects, including data review/monitoring, audit trails, and electrical engineering.
Interact regularly with Manufacturing, Maintenance, Process Engineers, Plant Engineering, Validation, Quality, and other functions.
Monitor and analyze data for process improvements and issue resolution.
Author, review, and approve change controls, deviation investigations, standard operating procedures (SOPs), drawings, schematics, and work orders.
Identify Process Control and Data Integrity knowledge gaps that impact equipment and process capability.
Maintain and enhance Process Control and Building Management Systems.
Develop project scope, including user requirements, design, functional specifications, and engineering drawings.
Influence functional groups regarding operability, technical feasibility, engineering design, maintenance, spare parts, installation/shut-down coordination, project schedule, and validation/documentation requirements.
Arrange for procurement of equipment and instrumentation for projects.
Work with professional consultants and mechanical contractors to develop design and construction drawings/specifications and to implement and test changes.
Lead installation, start-up, commissioning, and qualification activities.
Provide on-call after-hours and weekend support to ensure continuous production.
Keep up to date with required training and develop expertise by attending technical seminars and training sessions.
Perform all job functions with adherence to company policies, in a cGMP manner, safely and ethically.
Own the data integrity program supporting manufacturing, maintenance, and engineering.
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.
Coach and mentor front-line Process Control engineers in fundamental Process Control support, problem-solving, project management, and Process Control architecture and design.
Present and attend various Governance teams for technical initiatives and collaborate with other key officials and support groups.
Review, approve, and promote documentation of learning points, technical studies, and event investigations.
Utilize optimization resources and tools for Process Control assets monitoring and improvement.
Provide guidance on key elements of return to service requirements for equipment after interventions.
Support scope development for capital projects and act as user representative.
Relate experiences with troubleshooting bioprocess equipment (e.g., Bioreactors, chromatography, TFF, CIP).
Champion the application of statistical thinking and use of data to monitor process performance and make engineering decisions.
Ensure operational Process Control systems are appropriate and implemented.
Support development and technical analysis for large-scale initiatives.
Perform and promote optimization of unit operation cycle time, Process Control system performance, and process system improvement.
Proactively work on Life Cycle Management (LCM) of Process Control assets, reliability of Process Control assets, and continuous improvement of Process Control systems.
Provide technical oversight of Asset Qualification Management for Direct Impact systems.
Ensure constant state of qualification and support development of equipment and process system User Requirements and related Design Review/Qualification documentation.