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Commissioning & Qualification Engineer

Imsmb

This is a Full-time position in Richmond Hill, ON posted June 15, 2021.

Commissioning & Qualification Engineer* Full-time permanent position* Located on client project site – GTA* Competitive salary, commensurate with experience* Work for a solutions-oriented company with a great company work culture, committed to employee development and growthWho are you?As an experienced Commissioning & Qualification Engineer, you know better than anyone else, how to manage the polarity of speed and quality.  You have the right blend of technical knowledge and the ability to solve and overcome project challenges, combined with strong communication and collaboration skills that lead to incredible success.Who is the employer?We’re Ian Martin Group (https://ianmartin.com/) , and we’ve partnered with our client, a boutique engineering firm dedicated to delivering best-in-class engineering services across Canada.  They work with a variety of industries and sectors including biotechnology, pharmaceuticals, botanicals & natural healthcare, science & tech, nuclear, food & beverage, etc. As a process engineering & project management partner, they offer end-to-end solutions from commissioning and qualification of equipment to final validation of process.  Their subject matter experts deliver quality results that will ensure operational readiness to best meet their clients’ needs today and in the future.What you’ll be doingAs the new Commissioning & Qualification Engineer, you’ll report to assigned project managers and will be responsible for the commissioning and qualification of equipment and systems.  In this role, the primary objective is to develop and execute commissioning and qualification protocols.You’ll work on projects that are site based in a variety of market segments including biotechnology, pharmaceuticals and science & tech.  You’ll be an ambassador, behaving in a manner consistent with our client’s company values.  You’ll work with the project team to plan, develop, manage and execute the following:* Commissioning protocols, including, Factory Acceptance Testing (FAT), Site Acceptance Testing (SAT), Commissioning Test Procedure (CTP)* Ensuring Installation and Operational protocols are in place and documented* Completing CQV Requirements Traceability Matrices during project execution* Validation of Master Plans and Quality Plans* Qualifying summary reports for all stages of commissioning and qualification* Supporting the coordination, management and implementation of commissioning and qualification activities as required.* Applying both company and client commissioning and qualification process guidelines as well as industry standards to ensure high quality project delivery* Completing system boundary reviews* Supporting traceability matrix generation* Supporting SOP creation and updates* Writing reports* Supporting vendor documentation review and facility and/or equipment start-up* Identifying potential risks with project execution* Identifying and reporting any safety related issues* Traveling to client sites as needed* Maintaining effective communication with project team* Communicating directly with engineering, automation, and construction groups for documentation requirements.* Planning, scheduling, and tracking project timelines and milestones using appropriate tools* Performing system deficiency identification, conduct root cause analysis, and develop potential solutions or recommendations.* Identifying and communicating potential risks to projects execution and schedule adherence and develop potential solutionsThe best in this role will bring more than strong CQ&V skills. They will be solution-oriented, have a high attention to detail, be tenacious, work well under pressure and can work under minimal supervision as part of a cross-functional team.  They are personable, have strong written and oral communication skills, can speak intelligently about technology, are curious about different technologies and software, and have an appetite for personal and career growth.The DetailsThis is a full-time, permanent position, working Monday to Friday with occasional long working days and weekend work to support client projects.  The role offers a competitive salary commensurate with experience.  You’ll also receive a benefits package, vacation time, laptop, wellness program, cellphone, and company/personal performance-based bonus.  You’ll work on client site primarily located within the greater Toronto area.   Qualifications* At least 3+ years of commissioning and qualification experience in a pharmaceutical or biotech manufacturing environment* Ability to understand, verify and mark-up engineering design documents (P&ID’s, electrical drawings, functional specifications, design specifications, etc.)* Familiarity with cGMP, GDP, and regulatory requirements (FDA, Health Canada, EU) that govern the pharmaceutical/biotech industry and regulatory bodies* Understanding of automated process control systems in a manufacturing setting, and well versed in PLC program logic, HMI interfaces, process instrumentation, I/O’s, and ISA-88 batch control (strong asset but not mandatory)* Understanding of validation using a risk-based approach (ASTM E2500 Standards)* Experience with Microsoft Office to create new documents/reports and to fill in templates, especially Word and Excel* Valid driver’s license, and owner of a car with the ability to work on client site* Being multilingual is an asset* Degree from a recognized Canadian University/College in engineering, or science is considered an asset but not mandatoryYour ApplicationWe value diversity and inclusion and encourage all qualified people to apply. We encourage all qualified candidates to apply; however, only those selected for an interview will be contacted.At Ian Martin, we connect people with meaningful work. We work with people like you for similar technical roles. If you apply, be sure to create a profile with us. That way, great technical jobs will come to you before they even get to the job boards!