Industrial Automation/CSV Engineers

Industrial Automation/CSV Engineers

We are seeking forward-thinking, ambitious engineers looking to accelerate their careers in the pharmaceutical, biotechnology, and medical device industries. We offer an opportunity to support our teams of industry subject-matter experts and thought leaders while consulting with leading companies in the Life Sciences industry.

We are seeking multiple experienced Industrial Automation and CSV/CSA professionals to support the commissioning and qualification activities of FAT, SAT, Software V&V, IQ, and OQ, including authoring, editing and execution of automated assembly and inspection equipment for our Medical Device client.

Approximately 15 weeks of FAT execution will take place at the integrator''s facility in Toronto, Canada, followed by approximately 8 weeks of installation and SAT execution in Mesa, Arizona.

The successful candidate will support Factory Acceptance Testing (FAT), Site Acceptance Testing (SAT), installation, commissioning, software verification, and validation of automated assembly and inspection equipment used in the manufacture of medical devices. Responsibilities include executing testing protocols, documenting results, resolving issues, and coordinating with engineering, quality, and equipment vendors.

PROJECT OVERVIEW

• Location:          Phase 1, Toronto, Canada, for approximately 15 weeks (Sep – Dec 2026)

                                             Phase 2: Mesa, Arizona, for approximately 8 weeks (Jan-Mar 2027)

• September 2026 to March 2027
• Employment Classification: Contract
• 100% On-site.

KEY RESPONSIBILITIES

• Author, Edit and Execute FAT, SAT, IQ, TMV, Gage R&R and OQ protocols.
• Support equipment installation and commissioning.
• Perform PLC, HMI, databases, vision systems and SCADA functional testing.
• Verify alarms, interlocks and safety functions.
• Troubleshoot automation equipment and assembly issues.
• Document deviations and work with vendors on resolution.
• Support turnover to manufacturing.
• Participate in punch-list resolution.
• Assist with commissioning documentation and turnover packages.
• Support change control activities during commissioning.

REQUIRED QUALIFICATIONS

Education

• Minimum Bachelor’s degree in Life Sciences, Computer Science, Engineering, Information Systems, or a related field.

Experience

• 6 years minimum experience working with PLC and SCADA-controlled Industrial Automation Assembly equipment in regulated environments, with medical device assembly strongly preferred.
• Demonstrated experience authoring and/or executing FAT, SAT, IQ, OQ, and Test Method Validation (TMV) protocols for automated manufacturing equipment.
• Experience performing software verification and validation, including logic testing, alarm verification, feature testing, unit testing, integration testing, and user acceptance testing.
• Expertise in Rockwell Automation suite and Factory Talk View
• Experience working with databases and data integrity principles.

Travel

·        Candidates should reside within commuting distance of the Toronto/Cambridge area or be willing to temporarily relocate during the FAT phase.

·        Candidates should expect to work on-site in Toronto for approximately 15 weeks, followed by travel to Mesa, Arizona, for approximately 8 weeks to support equipment installation, SAT, and IQ/OQ activities.

·        Company-paid travel and lodging will be provided for the Mesa assignment.

Technical & Regulatory Knowledge

• GMP regulations
• Good Documentation Practices (GDP)
• FDA 21 CFR Part 11
• EU Annex 11
• GAMP 5
• Data integrity principles (ALCOA+)
• Commissioning principles
• Equipment lifecycle documentation

Key Competencies

• Strong technical writing and documentation skills
• Excellent organizational and project coordination abilities
• Ability to communicate effectively with scientific, QA, and IT teams
• Detail-oriented with strong compliance mindset
• Ability to manage multiple priorities in a fast-paced environment

Ideal Candidate

• Hands-on experience with automated manufacturing equipment commissioning.
• Comfortable working in a fast-paced FAT environment alongside equipment vendors.
• Able to troubleshoot PLC / HMI / Vision systems / Database issues and document testing results.
• Willing to travel internationally and work on-site throughout the project.
• Strong communicator who can work effectively with engineering, quality, and manufacturing teams.