CQV Engineer

Pharm Eng Technology has been providing quality services to leading manufacturers of healthcare and pharmaceutical products since 1997. Our specialists hold expertise in Commissioning & Qualification, Validation, Quality Systems, Regulatory Affairs, Engineering, and Training to ensure that our clients can keep on providing the world with their cost-effective and high-standard healthcare products.

At Pharm Eng Technology, we strive to cultivate the best working environment where empowerment, passion and perseverance are nurtured while serving our clients to achieve their unique business goals.

We are seeking an experienced CQV Engineer based in Toronto, Ontario, to help drive our solution-based business model and take our designs to the next level. Our Consultants have the chance to work hands‑on with several business divisions to design, develop, and test industry‑leading solutions for our clients—both nationally and internationally. Our ideal candidate is a creative thinker who shares our passion for making people’s lives easier.

• Responsible for providing direct services to site Technical Services management, aiding to increase the throughput of commissioning and qualification activities through the department and across the site.
• Will work with Technical Services management but be expected to perform required activities related to validation independently.
• This position will support C&Q activities across the site as directed by site Technical Services management.
• Review site commissioning and qualification documentation for accuracy, technical soundness and compliance to both site and regulatory guidelines.
• Projects may include new facilities/equipment startup, commissioning, FAT, manufacturing equipment qualification, laboratory equipment qualification and computerized and automation systems including FMS and BMS systems.
• Provide support for the development of user requirements and functional specifications.
• Support the generation and execution of all commissioning and qualification documentation related to demonstration batches, thermal studies, validation studies for equipment, facilities, utilities, engineering test runs, development studies, software validation and final reports.
• Recommendations to management as to the acceptance and release of qualified systems.
• Actively participates during all phases of validation projects. Evaluates projects, provides technical information to others.
  
  Review technical and quality system documents such as SOPs, Change Control and Deviation Reports, Batch Production Records, Technical Manuals, P&IDs, construction, as-built, flow diagrams as they relate to validation principles and regulatory compliance issues.
• Review various documentation and drawings to ensure any document changes, meet quality and validation requirements and are in full compliance with regulations and standards.
• Provide technical assistance during investigations of process /equipment / cleaning / validation issues and aid in the resolution of validation deviations, protocol discrepancies and non-conformances.
• Support, investigate and troubleshoot problems and determine possible solutions.
• Provide effective solutions for the management of system deviations and non-conformances.

• Bachelor's degree in technical field (engineering, biology, chemistry, pharmacy)
• Two (2) to five (5) years of applied technical experience within the CQV space of the pharmaceutical, health sciences, or biotech industries.
• Hands on commissioning, qualification and validation experience in at least two (2) of the following disciplines is preferred:
  Facilities (including design, flow analysis, HVAC), Utilities (including WFI / RO/ purified water, clean steam, clean air, compressed air and gases, process waste systems), major equipment, process / cleaning and equipment validation / qualification or computer software validation.
• Firm understanding of cGMP validation requirements / guidelines and current industry practice.

• Comprehensive benefits package & competitive wages.
• A supportive environment where employee growth is promoted.
• Paid holidays.
• Other great incentives.

At Pharm Eng Technology, we don’t just accept difference — we celebrate it, we support it, and we thrive on it for the benefit of our employees, our clients, and our community. Pharm Eng Technology is proud to be an equal opportunity workplace.