Validation Specialist

ATS Automation; Cambridge; Hybrid; CAD 80,000 - 100,000; Full time

Job summary

A leading automation solutions provider in Cambridge, Ontario, seeks a Validation Engineer to oversee and execute validation activities for medical device and pharmaceutical automation systems. The ideal candidate will have a Bachelor’s degree in science and over 3 years of relevant experience, demonstrating strong technical knowledge and excellent communication skills. The position offers numerous professional growth opportunities along with benefits that promote work-life balance.

Benefits

Competitive starting salary

Employee Incentive Bonus program

Comprehensive health and dental benefits

Tuition reimbursement program

Qualifications

• 3+ years of directly related experience.
• Demonstrate ability to work in a cross-functional team environment.
• Prior experience with automation equipment validation is an asset.

Responsibilities

• Coordinate and execute validation activities including protocol writing.
• Develop and design custom test plans for projects based on engineering knowledge.
• Lead review meetings to approve validation documentation.

Skills

Strong communication and interpersonal skills

Technical understanding of pharmaceutical / biotechnology unit operations

Good knowledge of cGMP requirements

Ability to adapt to changes in priorities

Education

Bachelor’s degree in science (engineering, physics or chemistry preferred)

Tools

PLC programming software (RSLogix or Siemens Step 7)

AutoCAD

SolidWorks

Microsoft Office Suite (Excel, Word, Outlook, Project)

Job description

The world isn’t standing still, and neither is ATS Life Sciences - We don’t follow the trends. We set them!

Are you interested in being part of a team that makes a difference? Join our growing ATS Life Sciences Systems team a division of ATS Corporation, a publicly traded global enterprise with a proud history, we are helping advance the future with our factory-wide automation solutions. Within Life Sciences Systems, what we do matters – we custom design, build and service critical automated solutions for medical device and pharmaceutical companies. We are dedicated to assisting our customers in improving the quality of life for people around the world. When there is no room for error, and product failure is not an option, leading life sciences companies trust us to resolve their production challenges.

Job Description

MAJOR DUTIES:

Provide the coordination, creation and execution of validation activities including (but not limited to) writing protocols, performing qualifications, review of documents that support the manufacturing of automated equipment on large single module custom machines or large multi-module custom systems or replication projects. In addition, the candidate will understand how the various pieces of automated equipment operate and understand the principle of Life Science Validation and Engineering.

SPECIFIC RESPONSIBILITIES:

• Administer, create, maintain, and execute validation plans, procedures, and protocols for projects.
• Work with technical and engineering personnel to prepare and create validation related documentation and functional specification documentation.
• Develop and design custom test plans for projects based on similar projects and templates and engineering knowledge
• Lead review meetings with the internal team and customers to review and approve validation related documentation
• Organize, lead and report on validation efforts at both ATS and at the customer’s site.
• Read and examine the schematics, blueprints, electrical drawings and confirm the electrical wiring connections of industrial equipment as per design.
• Execute installation qualification to verify installation and function of e-stops, guard doors, safety switches, feeders, safety light curtains, contactor, relays, HMI, pneumatic regulators, fiber-optic and coaxial cable sensors, switchboard meters and other electrical components at ATS and occasionally at customer sites.
• Verify testing of electrical utilities including current, voltage and panel ratings. Perform continuity testing on digital inputs and outputs, using PLC access, multimeter or visual check.
• Perform the installation qualification and operation qualification to test the instrumentation devices, vision system, PLC, electrical motors, and other hydraulic and pneumatic electrical control systems.
• Use the PLC, VFD, HMI and other electrical control system components to trigger faults and machinie alarms in order to verify machine programming and fault handling.
• Conduct the calibration of industrial instruments or evaluate and maintain the calibration records.
• Lead the generation and completion of any deviations, equipment and document change control resulting from testing, qualification and /or validation activity.
• Take a validation project lead role for the duration of a project lifecycle, including being a primary validation contact for customers, ATS project managers and other project stakeholders and coordinating additional validation team members assigned to the project
• Assist in defining and implementing acceptance criteria, specifications, and standards for each qualification activity.
• Ensure that all business activities are performed with the highest ethical standards and in compliance with the ATS Code of Business Conduct.

Qualifications

Education:

• Bachelor’s degree in science (engineering, physics or chemistry preferred) or equivalent experience and greater than 3 years of directly related experience.

Experience:

• Technical understanding of pharmaceutical / biotechnology unit operations.
• Technical understanding of general automation equipment design and principles.
• Strong communication and interpersonal skills.
• Good knowledge of cGMP requirements and current Life Science industry practices (ISPE C&Q Guidance and GAMP5).
• Demonstrate ability to work in a cross-functional team environment.
• The ideal candidate will possess excellent planning and coordination skills and be able to readily adapt to changes in priorities and project schedules.
• Prior experience with automation equipment, Life Science equipment validation and project engineering would be an asset.
• Experience with Windows, Excel, Word, Outlook and Project. Should have some understanding of AutoCAD and Solid works as well as PLC programming software like RSLogix or Siemens Step 7.
• Ability to travel in the USA and Europe

If you're excited about this role, but do not meet all the qualifications listed above, you are still encouraged to apply

Why YOU should join our ATS Life Sciences Systems team:

We value our PEOPLE - The foundation of a great company is having the best team which is why we continuously work to develop, engage, empower and energize our people. The best people want to work with the best team - the best teams are diverse and inclusive teams.

What we do MATTERS - our Life Sciences projects contribute to improving the lives of people around the world! ATS has made a commitment to be carbon neutral by 2030!

INNOVATION and PROBLEM SOLVING is at our core - Our pursuit of continuous improvement in everything we do. Our focus is on building diverse teams, stimulating innovation by challenging conventional thinking, encouraging fresh ideas and promoting creative problem-solving

We prioritize internal GROWTH & DEVELOPMENT - ATS offers endless opportunities for professional growth and development – with a tuition reimbursement program, individual development programs and a commitment to promoting from within - there is space for you to grow your career at ATS!

We offer COMPETITIVE Total Rewards - Competitive starting salaries, overtime pay eligibility, paid vacation, Employee Incentive Bonus program, comprehensive health and dental benefits including Lifestyle Spending Account, 5% RRSP matching program and optional Employee Share Purchase Program

A place to BELONG: We celebrate our differences and ensure that all employees have equal opportunities for growth and development. We believe that diversity of thought, background, and experiences is essential for our success and innovation.

ATS is in compliance with the Accessibility for Ontarians with Disability Act (AODA), 2005 and will, upon request, assist those who may require specific accommodations due to a personal disability. We would ask that those who require assistance to notify our offices as soon as possible if accommodation is necessary