Automation Engineer

Automation Engineer

Location: Pennington, N

JSchedule: Full-Time | Onsite (5 Days per Week

)Employment Type: Contract/Freelance with the opportunity to transition into a long-term permanent positio

n
About the Opportuni

tyOur client, a leading biotechnology manufacturing organization, is seeking an experienced Automation Engineer to support and optimize manufacturing automation systems across a GMP-regulated production site. This position plays a key role in ensuring the reliability, compliance, and continuous improvement of automation infrastructure used in manufacturing, quality control, and facility operation

s.
Working closely with engineering, manufacturing, quality, and IT teams, you'll help maintain validated systems while supporting new equipment implementations, system upgrades, and lifecycle management activiti

es.
Key Responsibili

• tiesManage the day-to-day performance, maintenance, and lifecycle of manufacturing automation systems, including SCADA platforms, PLCs, laboratory systems, and supporting softw
• are.Partner with manufacturing, engineering, quality, and IT teams to gather requirements and deliver reliable automation solutions that support site operati
• ons.Support the implementation, qualification, validation, modification, and retirement of computerized systems in line with GMP expectati
• ons.Develop and execute validation documentation, including qualification protocols, test scripts, reports, and lifecycle reco
• rds.Monitor automation systems to ensure reliability, availability, security, and optimal performa
• nce.Troubleshoot system issues, investigate equipment failures, perform root cause analysis, and implement corrective acti
• ons.Coordinate software updates, configuration changes, patches, and system enhancements through established change management proces
• ses.Administer system access, permissions, backups, and recovery procedu
• res.Maintain automation documentation, standard operating procedures, and system administration reco
• rds.Support compliance with FDA, GAMP, 21 CFR Part 11, Annex 11, and other applicable regulatory requireme
• nts.Collaborate with vendors and internal stakeholders during new equipment installations, system integrations, and technical proje
• cts.Act as the automation subject matter expert for technical changes and continuous improvement initiati
• ves.Evaluate opportunities to introduce new technologies and process automation solutions that improve manufacturing efficie

ncy.
Required Exper

• ienceBachelor's degree in Electrical Engineering, Computer Science, Automation Engineering, Information Technology, or a related technical discip
• line.Approximately 5 years of experience supporting automation systems within a regulated pharmaceutical, biotechnology, or life sciences manufacturing environ
• ment.Strong understanding of SCADA, PLC, HMI, and industrial control systems used within GMP manufactu
• ring.Experience with computer system validation (CSV), equipment qualification, and automation system lifecycle manage
• ment.Familiarity with industrial networking concepts and manufacturing system architec
• ture.Hands-on experience supporting automation platforms and process equipment in a production environ
• ment.Knowledge of regulatory expectations surrounding computerized systems, including FDA regulations, GAMP 5, 21 CFR Part 11, and EU Anne
• x 11.Experience with change control, deviation investigations, CAPAs, and validation documenta
• tion.Comfortable working across cross-functional teams while managing multiple priorities in a fast-paced manufacturing environ

ment.
Preferred

SkillsExperience with one or more of the following technologies would be advanta

• geous:Rockwell Automation / Allen-Bradle
• y PLCsWonderware or AVEVA System Pl
• atformEmerson
• DeltaVSCADA and HMI pla
• tformsLaboratory automation s
• ystemsManufacturing systems such as SAP, Maximo, or Veeva
• VaultProcess equipment including bioreactors, chromatography systems, filtration equipment, and analytical laboratory instrumen