CQV Engineer

2 weeks ago

Toronto, Canada Trinity Consultants - Advent Engineering Life Science Solutions Full time

We are looking for CQV and Validation Engineers who are Canadian Citizens that would like to work out of the US.

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:
Execute IC/OC commissioning protocols for Aseptic Filling Lines, Facilities and Utilities
Troubleshoot and resolve all commissioning issues
Generate the commissioning summary reports for all respective protocols.
Generation of the qualification protocols for the Aseptic Filling Lines, Facilities and Utilities
Execute IQ/OQ qualification protocols.
Troubleshoot and resolve all qualification issues
Generate the qualification summary reports for all respective protocols.
Resolve all issues encountered
Generate the required subsequent reports.
Assist in the generation of the required PQ protocols
Execute the PQ protocols.
Resolve all issues encountered and
Generate the required subsequent reports

Qualifications

Requires a bachelor’s or master’s degree in Scientific (Biotechnology) or Engineering (Mechanical, Chemical or Biochemical Engineering) degree. 2-10 years of experience in the biotech-pharmaceutical academic or industrial environment.
Basic knowledge of fermenters and unit-operations of fermenters
Basic knowledge of cycle development for CIP and SIP
Basic knowledge of regulatory compliance inclusive of cGMP, OSHA, EPA, FDA regulations.
Basic technical writing with proficiency in Excel, PowerPoint, Visio, Word, Sharepoint, etc. in addition to experience working within shared work environments.
Basic knowledge of the Commissioning and Qualification.

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. Accepting US Citizens and Green Card Holders.

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