CQV Engineer
Cheme
- Vaughan, ON
- Permanent
- Full-time
- 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.
- Bachelor of Applied Science degree in engineering from a recognized Canadian university or equivalent.
- 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.
- 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
- 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