Location: Buena, NJ
Reporting Relationships: Individual Contributor
- Experience with regulatory requirements for process control systems and instrumentation specifically as it relates to electronic data records and electronic signatures.
- Experience with packaging line serialization equipment including software upgrades, line level troubleshooting, and development of label templates.
- Recommend and implement process improvements using automation solutions.
- Use knowledge and experience to optimize control strategies.
- Understand budget, process schedules and financial impact and interact with business to minimize downtime and mitigate risks to project delivery.
- Communicate issues and drive issue resolution.
- Influence decisions on Control System selection, design, validation and strategy.
- Improve productivity through effective application and replication of successful automation and control solutions.
- Identify customer requirements and develop automation solutions to meet the customers’ needs.
- Provide system administration duties for automated systems including the Building Automation System (BAS) and the Environmental Continuous Monitoring System.
- Manage multiple projects involving retrofits, optimization and acquisition of process systems.
- Assist in resolving technical issues with automation problems and support investigation as required for manufacturing systems.
- Support system life-cycle documentation for automated control systems.
- Develop and update engineering specifications, policies and procedures.
- Participate in internal audits and provide support during external regulatory audits.
- Maintain and document all cGMP equipment/system modifications and upgrades through approved change control methods.
- Interface with external vendors & service providers.
- Other duties as assigned.
- Bachelor’s degree in Engineering or other technical Degree (Computer/Biotechnology) w/direct relevant experience.
- 8 or more years’ experience with process control systems or related function.
- Experience in the pharmaceutical industry working with control of manufacturing equipment, processes, and utilities.
- Project and/or administrative experience with many of the following: Data Historians (IP21, InSQL), Networking, Servers, DCS (DeltaV), PLC (Allen Bradley), BAS (Trane and Rees), ControlLogix, WonderWare.
- Experience editing process control software and programs.
- Understanding of process controls principles for networks, process computers, controllers, and instrumentation.
- The ability to read, understand, and troubleshoot using control schematics, I/O diagrams.
- Experienced maintaining system life cycle documentation (Drawings, Design Files, FRS, SDDS, etc).
- Experience managing projects, budgets, scoping, design, and implementation within a Change Management environment.
- Experience validating computerized systems including protocol generation and execution.
- Demonstrated ability to work in a team environment.
- Excellent communication skills.
The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job.
- While performing the duties of this job, the employee is regularly required to talk or hear.
- Employee is frequently required to stand for long periods of time; walk; use hands to handle or feel; and reach with hands and arms.
- Employee is occasionally required to sit; climb or balance; and stoop, kneel, crouch or crawl.
- Specific vision abilities required by this job include close vision, distance vision, color vision, peripheral vision, depth perception and ability to adjust focus.
- The employee must be able to wear all required PPE, including safety glasses, ear plugs, and safety shoes.
Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
This job description is not all-inclusive. It acts as a guideline and is subject to change over time. Additional duties may be assigned based on business needs.