CQV Engineer

Position : CQV Engineer

Location : Toronto, Canada

ADVENT Engineering is an engineering and consulting firm providing expertise to the pharmaceutical and biotechnology industries.

Head-quartered near San Francisco, California, and with operations in the Eastern and Western US, Canada and Singapore, our company is involved in almost every facet of global pharmaceutical and biotechnology facility design and process engineering and quality system projects.

ADVENT's services include process engineering, automation engineering, project engineering, facility / system design, start up and commissioning, validation and compliance consulting for distinguished and successful biotechnology and pharmaceutical manufacturing companies.

The successful candidate will work with a group of engineers involved in the design, automation, commissioning and start-up of various processes, systems and facilities.

A combination of strong technical aptitude, automation engineering skills and technical writing are the desired skill set.

This is an outstanding opportunity to join our growing team!

Responsibilities

• The role entails the primary job functions :
• Prepare validation strategy documents (e.g. project specific plans, validation plans, risk assessments etc)
• Generate commissioning documents for process / GxP and non-GxP equipment
• Execute commissioning documents
• Troubleshoot and resolve all commissioning and qualification issues
• Generate documents related to commissioning and qualification of process equipment and facilities (e.g. FCCA, SIA, DQ, RTMs and reports)
• Generate qualification documents for process / GxP equipment
• Execute qualification documents including CSV tests
• Troubleshoot and resolve all qualification issues
• Assist or generate VHP development and Autoclave cycle development protocols
• Execute cycle development protocols
• Assist or generate performance qualification protocols for equipment
• Execute performance qualification protocols
• Generate and execute Facility qualification for upgraded facilities and HVAC systems.
• Resolve all issues encountered

Qualifications

Requires a bachelor’s or master’s degree in Scientific (Biotechnology) or Engineering (Mechanical, Chemical or Biochemical Engineering) degree.

2-8 years of experience in the biotech-pharmaceutical academic or industrial environment.

• Basic knowledge of process / GxP equipment for Fill, Finish, Inspection and Packaging Equipment
• Basic knowledge of cycle development for autoclaves and VHP
• Basic knowledge of regulatory compliance inclusive of cGMP, OSHA, EPA, FDA regulations.
• Basic technical writing with proficiency in KNEAT, Excel, PowerPoint, Visio, Word, Sharepoint, etc. in addition to experience working within shared work environments.
• Basic knowledge of the Commissioning and Qualification.
• Basic knowledge of using a Kaye validator or Data Loggers
• Basic knowledge of DeltaV

Candidates please note : Kindly ONLY apply if you meet the experience expectations described : Experience in GMP pharmaceutical and / or biotechnology facilities in design, engineering, quality or manufacturing is a MUST.

Interested candidates with direct related experience in US or Toronto locations are encouraged to apply.