Do you want to join us in helping to fight the world’s most threatening diseases and enabling access to care for more people around the world? At Siemens Healthineers, we pioneer breakthroughs in healthcare. For everyone. Everywhere. We offer you a flexible and dynamic environment with opportunities to go beyond your comfort zone in order to grow personally and professionally. Sound interesting? Then come and join our team as Validation Engineer (12 month term). Under the supervision of the Manager, Mechanical Process Engineering; the Validation Engineer is responsible for leading validation activities, developing/executing process improvements and for generating and completing other technical activities and documents to support the efficient manufacturing of Epocal’s products in a manner consistent with CGMP and the Epocal QMS. Our global team: We are a team of 66,000 highly dedicated employees across more than 70 countries passionately pushing the boundaries of what’s possible in healthcare to help improve people’s lives around the world. As a leader in the industry, we aspire to create better outcomes and experiences for patients no matter where they live or what health issues they are facing. Our culture: We are part of an incredible community of scientists, clinicians, developers, researchers, professionals, and skilled specialists pushing the boundaries of what’s possible, to improve people’s lives around the world. We embrace a culture of inclusivity in which the power and potential of every individual can be unleashed. We spark ideas that lead to positive impact and continued success. Our impact: • 70% of critical clinical decisions are influenced by the type of technology we provide. • More than 31 million Canadians benefit from Siemens Healthineers products every year. • An average of 85,000 Canadians per day receive treatment or tests from a Siemens Healthineers device. • Siemens Healthineers participates in 30 healthcare research collaborations in Canada and around the world. https://www.healthcare.siemens.ca/healthcare-company-profile/about The Validation Engineer is based on site in Ottawa, ON. Siemens Healthineers Ottawa (SHS Ottawa) is a leading manufacturer of a clinical Point of Care (POC) diagnostic product. The epoc© Blood Analysis System is healthcare’s first cost-effective POC testing solution to leverage Smartcard Technology and wireless communication to provide caregivers with real-time, lab-quality blood gas, electrolyte, and metabolite results at the patient bedside. The Validation Engineer will have regular interaction with Manufacturing and Development engineers, technicians, and operators in supporting the next generation product line. This is a role well suited to an ambitious professional, looking for the next step in their career. As the Validation Engineer, your responsibilities will include: Taking the lead on drafting process validation protocols (IQ, OQ, PQ, TMV’s), or modifying existing documentation, for equipment, utilities, and facilities, according to required process implementation or changes. Organizing and participating in required execution of validation protocols and drive the release of the corresponding report. Performing remediation of Verification & Validation results as required. Identifying, responding, and monitoring potential project risk and determine possible contingency plans for risk mitigation. Leading/participating in Risk Assessment and pFMEA activities, including contingency plans for risk mitigation. Managing and controlling validation documentation in collaboration with QA team. · Responsible for mapping of temperature-controlled environments and equipment (Incubators, Cold Rooms, Refrigerators, Freezers). · Ensuring adequate calibration of devices and equipment. Proactively identifying the need for process development and improvement initiatives and takes the lead on defining and implementing these initiatives. Understanding the Epocal Quality Management System and be able to successfully operate within its constraints. Establishing productive relationships with personnel from engineering, operations, quality assurance and other groups, including external contractors. Communicating with supervisor and others when issues are detected and improvements are required. As a successful Validation Engineer you will have: Undergraduate degree in Chemical or Mechanical Engineering is desired, other relevant disciplines such as Biochemistry, Biomedical Engineering or Engineering Physics may be considered. M.Sc. would be considered an advantage, and/or an equivalent combination of education and technical experience. Minimum of 3 years of related industrial experience. Experience with process development and validation in a regulated industry such as pharmaceuticals or medical devices, are both highly preferred. Knowledge of purified water and clean steam systems an asset. Experience with development of process control strategies is highly preferred. Experience with Risk Analysis and Root Cause Analysis tools is preferred. Demonstrated knowledge and skill in the use of statistical tools and application of statistical tools and application of statistical software programs (JMP, Minitab). We are looking for dedicated and talented people who tackle ever-changing challenges, customer needs, and questions from colleagues with clever concepts and creativity. We embrace change and work with curious minds re-inventing the future of work. Join us and let us focus together on what’s truly important: making lives better with new ideas and the latest technologies around the world. In our continued commitment to prioritize colleague health, comply with customer/business partner requirements, and help preserve our business continuity, Siemens Healthineers requires employees, contractors, and business partners to be fully vaccinated with relevant dose(s) of a Health Canada approved vaccine for all new hires by their start date. “Fully vaccinated” means it has been 14 days after receiving the full series of a COVID-19 vaccine or combination of COVID-19 vaccines approved by Health Canada (i.e. two doses of a two-dose vaccine series, or one dose of a single-dose vaccine series), and which may include, at the Company’s discretion, any further doses in accordance with Health Canada guidelines. will only be granted for medical reasons or on the basis of a protected ground under applicable human rights legislation. Organization: Siemens Healthineers Company: EPOCAL INC. Experience Level: Early Professional Job Type: Full-time Siemens is committed to creating a diverse environment and is proud to be an equal opportunity employer. Upon request, Siemens Canada will provide reasonable accommodation for disabilities to support participation of candidates in all aspects of the recruitment process. All qualified applicants will receive consideration for employment. By submitting personal information to Siemens Canada Limited or its affiliates, service providers and agents, you consent to our collection, use and disclosure of such information for the purposes described in our Privacy Code available at www.siemens.ca. Siemens s’engage à créer un environnement diversifié et est fière d’être un employeur souscrivant au principe de l’égalité d’accès à l’emploi. Tous les candidats qualifiés seront pris en considération pour ce poste. 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