Apply on Employer Site

LVI Associates · 3 days ago

Senior CQV Automation Engineer

Norton, MA

Full-time

Onsite

Senior Level

$100K/yr - $136K/yr

5+ years exp

LVI Associates is seeking a mid-to-senior level Automation Engineer to support Opex and Capex projects in a pharmaceutical manufacturing facility. This role focuses on the commissioning, qualification, and optimization of automated process equipment and control systems.

RecruitingService IndustryStaffing Agency

Growth Opportunities

Hiring Manager

Samuel Ankama

Responsibilities

Independently develop, configure, and test automated systems and control equipment, including PLCs, HMIs, and plant-wide automation networks

Analyze system performance, generate technical reports, and ensure all documentation meets cGMP, GDP, and regulatory standards

Proactively plan and manage automation commissioning and integration activities

Provide input on project timelines and ensure alignment with overall facility schedules for both CapEx and OpEx initiatives

Serve as the automation representative on project teams, coordinating with Engineering, QA, Operations, and Validation teams to deliver robust, compliant, and reliable automation solutions on schedule

Review and interpret technical documentation (e.g., URS, FS, P&IDs, SOPs) to develop system architecture and testing strategies

Translate specifications into functional test cases and ensure all automation requirements are fully verified and documented

Provide clear and timely updates on automation status, risks, and corrective actions

Independently troubleshoot system issues during commissioning and operational phases, implement solutions, and maintain optimized and compliant automated systems

Qualification

Automation commissioningControl system implementationRockwell PlantPAxElectronic validation systemsDocumentation PracticesTroubleshootingCross-functional collaborationProject management

Required

Must be able to meet on-site work requirements in Norton, MA

Bachelor's degree in a STEM field (Biomedical, Chemical, Electrical, or Mechanical Engineering preferred) or equivalent experience

5+ years of hands-on experience in automation commissioning, control system implementation, and process equipment integration in a GMP biotech or pharmaceutical manufacturing environment

Proven ability to manage, prioritize, and execute multiple automation projects simultaneously, ensuring on-time delivery and compliance

Strong proficiency in Good Documentation Practices and regulatory compliance within automated system development and operation

Willingness to work on-site outside standard business hours as needed to support system commissioning, troubleshooting, and optimization activities

Preferred

Hands-on experience with automation commissioning and qualification, including operation of automated manufacturing equipment (Rockwell PlantPAx preferred)

Experience performing chamber temperature mapping, worst-case load justification, and periodic requalification reviews to confirm the validated state

Experience with cleaning cycle development, rinse sampling, surface swabbing, and visual inspections to support cleaning validation or verification

Prior qualification/testing experience with process equipment (e.g., synthesizers, UF, HPLC, lyophilizers, CIP, WFI, clean utilities, cleanrooms) and systems using Unicorn software

Experience with electronic validation management systems (e.g., Veeva, Kneat, ValGenesis) and familiarity with PLC code/ladder logic to support testing and regression analysis