Purified Water Generation System Support

3 weeks ago

Canada, CA PQE Group Full time

Are you ready to join a world leader in the exciting and dynamic fields of the Pharmaceutical and Medical Device industries? PQE Group has been at the forefront of these industries since 1998, with 40 subsidiaries and more than 2000 employees in Europe, Asia and the Americas.

Due to our constant growth, we are looking for a full-time Purified Water Generation System Support position. This position supports the operational and technical teams in maintaining high standards of water quality, adherence to compliance requirements, and system reliability.


Responsibilities:


Execution of detailed Design Review of Purified Water Plant functional/technical/design specifications to ensure/verify that supplied Purified Water generation system:

  • Produces Purified Water in accordance with United States Pharmacopeia (USP) and European Pharmacopeia (EP)
  • Is compatible with the existing equipment in the building (including support utilities), the distribution loop, the Siemens building management system and the space constraints inside the room
  • Meets all applicable electrical and safety requirements to operate in Ontario, Canada
  • Is maintainable with spare parts being easily available and capability to perform all regular maintenance activities
  • Complies with Health Canada and US-FDA in terms of design principles, documentation requirements, process control requirements and 21 CFR part 11 compliance for all computer systems

Troubleshooting: candidate works with the technical team to address discrepancies arising from design review, providing corrective actions and preventive maintenance solutions


Requirements:


  • Bachelor’s degree in Life Sciences, Chemistry, Engineering, or a related field
  • In-depth knowledge of pharmaceutical water plants (purified water, water for injectables) design, components, integration in existing plants/systems, and quality/compliance aspects
  • High familiarity with US, Canada and EU GMP (Good Manufacturing Practices) and regulatory standards (e.g., USP, EP, EMA, 21CFR Parts 210-211 and 21 CFR Part 11)
  • Knowledge of Safety and Electrical standards applied to water plants in Ontario, Canada
  • Ability to interpret regulatory guidelines and apply them to practical situations.
  • Good communication skills and the ability to work cross-functionally with technical and compliance teams
  • Experience in validation, qualification, or audit support for purified water systems is a plus


Preferred Qualifications:


  • Experience with water system testing methods (conductivity, TOC, pH, etc.)
  • Understanding of the principles of water purification technologies, such as Reverse Osmosis (RO), CEDI, sanitation, safety controls (i.e. Canadian Electrical and Safety Codes), and distribution systems
  • Knowledge of FDA regulations and industry best practices related to water systems



Next Steps


Upon receiving your application, if a match is found, the Recruiting department will contact you for an initial HR interview. If there's a positive match, a technical interview with the Hiring Manager will be arranged. In the case of a positive feedback coming from the Hiring Manager interview, the recruiter will contact you for the next steps or to discuss our proposal. Alternatively, if the feedback is negative, we will contact you to halt the recruitment process.


Working at PQE Group


As a member of the PQE team, you will be part of a challenging, multicultural company that values collaboration and innovation. PQE Group gives you the opportunity to work on international projects, improve your skills and interact with colleagues from all corners of the world. If you are looking for a rewarding and exciting career, PQE Group is the perfect place for you. Apply now and take the first step towards an amazing future with us.

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