CQV Lead

CQV Lead (Biotech)

Location GTA, 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 :

• Lead and / or work with cross functional teams to complete all C&Q deliverables for assigned workstream (scope of equipment)
• Work with health and safety and Construction company to ensure that
• Compliance liaison between quality and commissioning teams to ensure quality and adherence to best practices are followed.
• Track and manage generation, investigation and resolution of any punch lists, deviations, change controls or CAPAs
• Forecast, Track progress and completion of CQ deliverables.
• Develop / update Project Governance documents, strategies, risk assessments, user specifications.
• Ensure all CQ documents (protocols, risk assessments, reports) are all completed on time.
• Plan, prepare and coordinate completion of all CQ activities for specific workstream
• Coordinate all CQ resources for execution readiness.
• Review and approve CQ documents (protocols, risk assessments, executed raw data packages and reports).

Qualifications

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

5 - 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.