Our client is seeking an experienced Automation Engineer to support the qualification and integration of new GMP process equipment within a regulated manufacturing environment. This position will be responsible for providing automation and control system engineering services, including PLC modifications, SCADA / MCS development, reporting, data integration, and GMP documentation.
The Automation Engineer will work closely with cross-functional teams to ensure the autoclaves are fully compliant, validated, and integrated into site systems.
Responsibilities
- Review and provide feedback on vendor software specifications.
- Modify and validate PLC logic for two new autoclaves.
- Develop or update SCADA / MCS screens for operator interface and control.
- Design and generate MCS reports (e.g., cycle reports, alarms).
- Update and configure SQL databases and OSI PI historian for data logging and reporting.
- Author and review GMP-compliant documentation, including :
Functional Specifications (FS)
Configuration Specifications (CS)Standard Operating Procedures (SOPs)Data Integrity (DI) assessmentsSupport Factory Acceptance Testing (FAT) and site installation with equipment vendors.Update control system and electrical drawings as needed.Participate in system commissioning and support IQ / OQ qualification activities.Provide hypercare support post-OQ to ensure a smooth transition to production.Attend weekly and ad-hoc project meetings.Collaborate with internal teams and end users to meet project objectives and timelines.Qualifications
Bachelor's degree in Automation Engineering, Electrical Engineering, Mechatronics, Chemical Engineering or related field.5+ years of experience in automation engineering within GMP-regulated environments (pharma / biotech preferred).Prior experience qualifying autoclaves or other GMP-critical equipment.Experience supporting capital projects in a biomanufacturing environment.Strong experience with PLC programming (e.g., Siemens, Allen-Bradley / Rockwell).Proficiency in SCADA / HMI development (e.g., Ignition, Wonderware / AVEVA, DeltaV).Experience with MCS / SCADA-based report development.Familiarity with SQL databases and OSI PI historian systems.Solid understanding of validation lifecycle and documentation (GAMP5, 21 CFR Part 11, EU Annex 11).Demonstrated ability to write and review Functional Specs, Config Specs, SOPs, and perform Data Integrity assessments.Proven track record supporting FAT, commissioning, and qualification (IQ / OQ) activities.Location
Andover, MAEmployment Type
Contract (18 months)Benefits
Choice of medical, dental, and vision plansPaid time offAbout Ventura Solutions
Ventura Solutions is a reputable end-to-end medical device and combination product consulting, staffing, and training firm. With our deep industry expertise spanning medical devices and combination products, coupled with an outstanding talent pool, we stand out as the preferred option for a diverse array of projects. On the consulting side, we integrate seamlessly into your team and manage small to complex Statement of Work (SOW) projects. On the staffing side, we help source, screen, and on-board reputable employees to fill temporary, temp to permanent, and permanent job openings. We accelerate product development, keep products compliant, and help build great organizations. For more information, visit us at www.ventura-solutions.com.
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