CQV Engineer

This is an opportunity to join a thriving process engineering firm serving a wide range of industries from pharmaceutical and biologics to science and technology and food and beverage.

At Cheme, we are a team of dedicated professionals who are passionate about our work and how we approach it. Cheme provides an environment where you will be challenged, supported, and given the freedom to thrive. We attract top talent by investing in our people through career planning, training, continuous education, development, and mentorship.

At Cheme, we believe that our business succeeds when our clients succeed, and our clients thrive when our people reach their full potential and beyond.

Cheme’s CQV Team (Commissioning, Qualification, and Validation) combine their technical knowledge and expertise in the GMP and the GDP documentation to develop, review and execute the testing and verification needed to qualify critical utilities, and to validate processes prior to release into production.

The position will be based out of either of our offices : Campbellville, ON or Vaughan, ON.

Job Description:

Cheme’s client is working on the implementation of a new facility to expand vaccine manufacturing capability including critical utilities, support utilities, upstream, and downstream processes. CQV engineering support is required for various upstream and downstream process equipment, critical and support utility systems. The selected individual will be responsible for CQV (Commissioning, Qualification, and Validation) (URS, FRS, FAT, SAT, IQ, OQ, PQ, PV etc.) Document’s preparation, review, approval, and execution.

Typical job duties include but are not limited to authoring, review, approval of the following documents:

• Traceability Matrix Generation
• Validation Master Plans
• Engineering Report
• Vendor and Equipment Documentation Review
• Factory Acceptance Testing
• Site Acceptance Testing
• Installation Qualification/Validation
• Operational Qualification/Validation
• Performance Qualification
• Periodic Review of GMP Systems
• Engineering Change Control records
• Engineering Change management records
• Identify and escalate project and safety risks to the project lead.
• Create test plans for qualification in collaboration with QA
• Regularly reports the status of assigned work
• Tracking all non-compliance issues and resolve with the vendor and/or client.
• Travel to client sites as needed and support start-up and testing activities.
• Communicate effectively within the project team and with client stakeholders for GDP requirements.

Requirements

Minimum Required Education:

• Bachelor of Applied Science degree in engineering from a recognized Canadian university or equivalent.

Core Competencies:

• Minimum of 3-year experience in the pharmaceutical industry, a minimum of 2-year experience in commissioning and qualification of GMP systems Primarily in the pharmaceutical industry (potential in other industries)
• Knowledgeable in commissioning and qualification of Critical Utilities:
• Water for Injection Generation and Distribution
• Clean Compressed Air Generation and Distribution
• Pure Steam Generation and Distribution
• Medical Gases
• HVAC systems
• Clean-in-Place and sterilize-in-place.

Required Skills:

• Proficiency in written and spoken English with the ability to communicate clearly with clients.
• Adept at dealing with client’s and other people in a professional and courteous manner.
• Use of Microsoft operating system and Microsoft Office Suite to navigate a server environment and prepare CQV documents.
• Experience with Kneat electronic validation software is not mandatory but is considered a strong asset
• Excellent organizational and multi-tasking abilities
• Works well under pressure
• Excellent communication and interpersonal skills are a necessity
• Personable, pleasant, and easy to relate to. Will make others feel comfortable and create a positive atmosphere
• Curious about different technologies and software and independent drive to become proficient
• Hands-on process engineering and/or operational experience
• Good GMP skills for completing qualification documentation
• Ability to work independently with minimal supervision
• Communicating and prioritizing projects with clients when conflicts or work scheduling issues arise

Benefits

• Extended Healthcare Plan (Medical, Disability, Dental & Vision)
• Paid Time Off Benefits
• Work From Home - Flexible hours
• Training & Development
• Bonus - Awards - Gifts
• Employee Assistance Program - Counseling