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.
· Lead the development of equipment validation master plans.
· 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.
· Participate in internal and customer design reviews.
· Analyze validation data, prepare reports, and make recommendations for changes and or/improvements.
· Perform machine testing and qualification on shop floor at ATS and occasionally at customer sites.
· Use technical skills to perform testing and problem solve issues that arise during testing, such as using the PLC to determine why an error occurred and test I/O’s using the PLC
· Lead the generation and completion of any deviations, equipment and document change control resulting from a qualification and /or validation activity.
· Assist junior team members in validation activities as needed
· 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
· Ensure that accurate records of all documentation delivered to customers are kept.
· Assist in defining and implementing acceptance criteria, specifications, and standards for each qualification activity.
· Interface with manufacturing, Mechanical and Controls Engineering group.
· Have an understanding of PLCs and HMIs pertaining to validation activities.
· Contribute to the development and maintenance of internal standards.
· Ensure that all business activities are performed with the highest ethical standards and in compliance with the ATS Code of Business Conduct.
· Adhere to all aspects of the department procedures.
· Perform other duties as assigned.
· Occasional overtime, shift work and weekend work may be required.
· Contribute to the development and maintenance of internal standards.
QUALIFICATIONS:
· Bachelor’s degree in science (engineering, physics or chemistry preferred) or equivalent experience and greater than 3 years of directly related 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
Join the Winning Team at ATS Automation, a great place to automate your future! Take your place among the best in the business, and grow your career with the Life Sciences division at ATS Automation. Join an environment where a passion for innovation is combined with an uncompromised commitment to quality.
We attract some of the most talented and motivated individuals from a range of fields, with our global offering and growth opportunities as we expand on a global scale.
Why Join ATS?
- Be a part of a global organization that is a leader in its industry
- Subsidized breakfast and lunch daily; free gourmet beverages - coffee, tea and hot chocolate. Plus, Treat Day is every other week!
- Monthly “In-Chair Massage” clinic on-site with a Registered Massage Therapist
- Ability to participate in a variety of charitable events
- Social Club that offers BBQs and other social events throughout the year
- Work with other bright, talented people and discover opportunities for professional growth
- And much more!
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.
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