Organization Overview:

For 140 years, the company has manufactured medicines that improve people’s lives around 
the world. We produce our medicines using some of the most sophisticated manufacturing 
technologies and rigorous quality standards. The company's Manufacturing strives for 
excellence in its process, standards, procedures and behaviors to develop medicines with 
safety first and quality always.

The company's employees embrace Operational Excellence in everything we do, to achieve our 
mission of Making Medicine with Safety First & Quality Always; following our common 
purpose under TEAM the company and our Manufacturing Standards under the strict code of 
conduct guided by our Red Book assuring data integrity in all we do in order to deliver a 
reliable supply of medicine for people around the world.

　

Responsibilities:


The Automation Engineer is　primarily responsible for the development and/or configuration 
of PLC/HMI codes, S88 batch recipe, historian data, historian reports, data analytics for 
reliable operation of manufacturing processes, and the existing automation systems, the 
front-line support for Building Management System (BMS), Utility and manufacturing process 
automation support for the company's New Jersey Facilities, as applicable.　Will work with 
cross function team to troubleshoot issues for reliable operation of automation systems. 
Will be supporting day to day automation 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 automation group in several process meetings.　

　Manage for Results /Strategic Planning: 　

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

Basic Requirements:　

Have attained a B.S. or M.S. in Engineering (typically, Chemical, Electronics, Electrical, 
Computer Engineering).　
Demonstrate a deep technical knowledge and experience with Rockwell (PLC/HMI) Automation 
Systems, as applicable.　　
Minimum 3 years of experience with OSI PI Historian, MS SQL database/ reporting, and Data 
Analytics tools, as applicable.　
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.　　
Have technical knowledge and experience with Automation Systems, as applicable.　
Have experience with frontline support in a GMP environment.　
Strong written and verbal communication skills.　
Curious to learn new technology.　　
Strong leadership skills, as applicable.　

Additional Skills:　

Minimum 2 years industrial experience in automation field.　　
Coach and mentor front-line automation engineers in aspects of fundamental automation 
support including automation understanding (both theoretical and practical), problem 
solving, project management, and automation architecture and design.　
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.　　　
Review, approve, and promote　documentation of learning points, technical studies, and 
event investigations, and identify knowledge gaps　that impact equipment and process 
capability.　
Utilize optimization resources and tools for automation assets monitoring and improvement.　
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.　　
Support scope development for capital projects targeted at both short- and long-term needs 
and act as user representative in some cases.　
Champion the application of statistical thinking and use of data to monitor process 
performance and make engineering decisions.　　
Ensure operational automation control systems are appropriate and implemented.　
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.　
Perform and promote optimization of unit operation cycle time, automation control system 
performance, process system improvement through condition/ metering-based monitoring.　
Proactively work on Life Cycle Management (LCM) of automation assets, reliability of 
automation assets, continuous improvement automation systems.　
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.　
Possess a passion for understanding, be inquisitive to what is happening in Automation, 
Data Analytics, and Electrical, as applicable.　
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.