Manager, Software Authority Validation

Canadian Nuclear Laboratories

  • Chalk River, ON
  • Permanent
  • Full-time
  • 1 month ago
Are you interested in a new and exciting opportunity? We are looking for a Validation Manager to be accountable for overseeing all aspects of the Validation Tasks, which includes CNL's Medical Isotopes Projects and Manufacturing. Does the idea of working on Validation Master Plan (VMP) and Computer System Validation (CSV) plans in accordance with the required Quality Program, which may include Good Manufacturing Practices (GMP) and Good Laboratory Practices (GLP) appeal to you? Do you see yourself holding the role of Software Authority and focusing on the quality assurance of Analytical, Scientific and Design Computer Programs standards? If so, apply now!What you will be doing!
  • Implementing validation systems and validation strategies. Establish and maintain the validation master plan and CSV plan for each validation stream.
  • Representing the validation department in regulatory inspections. Ensure all validation programs are designed to achieve right-first-time regulatory approval.
  • Providing oversight and validation expertise during the development of new products and new technologies. Write and approve the process and equipment validation protocols.
  • Participating in periodic reviews during product lifecycle to deepen process performance understanding and drive process improvement.
  • Effectively monitoring and communicating the validation workload requirement and priorities and communicate the validation projects execution plan to other departments.
  • Determining appropriate validation resource requirements around site plans. Provide clear visibility to the operation on the validated status of product/ equipment required for manufacture.
  • Developing and maintaining the Quality Plan and associated Management System enabling documents for Analytical, Scientific and Design (ASD) Computer Programs to ensure that the requirements of CSA N286.7, at a minimum, are met;
  • Ensuring that training on the ASD Software Program is available.
  • Ensuring uniform and consistent grading of ASD software across CNL
  • Ensuring that a list of ASD software is maintained (e.g., via the Library of Codes databases accessible from CNL intranet)
  • Ensuring adherence to the ASD Computer Programs for all ASD software developed in-house or acquired from a third-party and used at CNL
  • Ensuring that experience gained within CNL and other businesses on the use of ASD
  • Software codes is collected, reviewed for relevance and significance, addressed through appropriate actions, and shared within the business based on its sensitivity.
What we are looking for:
  • Bachelor’s degree in software, science or engineering
  • 8-10 years of experience in a GMP or other regulated industry, preferably in an engineering, validation, or operations role.
  • Experience managing a validation department within a GMP or other regulated environment, strategic leadership, and team development.
  • A minimum of 8-10 years of relevant experience, in particular related to software engineering, software development and validation, and must have a thorough knowledge of the software quality processes by which ASD computer programs are developed.
  • Experience in QA self-assessments, effectiveness reviews, surveillance, and auditing activities.
  • Experience in a nuclear environment.
  • Good project management skills with the ability to handle multiple activities simultaneously and deliver against deadlines.
  • Comfortable presenting to customers or regulators.
  • Completed project management courses recognized by PMI institutions or PMP certification are an asset.
  • Demonstrated experience in communication with Health Canada (HC) and the United States Food & Drug Administration USFDA
  • Knowledge of CSA N286.7 and it’s implementation in the nuclear environment.
  • Strong knowledge of current industry validation guidance and best practices.
  • Knowledge of EQMS (Electronic Quality Management Systems) and enterprise and data management systems, e.g. SAP, LIMS, Qualio.
  • Knowledge of electronic company quality systems.
  • Strong knowledge and understanding of Health Canada, FDA, ISPE process validation guidance’s and QbD (Quality by Design) approach. Knowledge of FDA, Health Canada, European Union (EU) guidance, ICH guidelines.
  • Demonstrate knowledge of CSV, Electronic Records/Electronic Signatures, 21 CFR Part 11, 210, 211, and 820 principles in the pharmaceutical industry.
  • Strong knowledge and demonstrated previous experience in Computer System Validation, ISPE GAMP 5 Risk Base Approach to Compliant GMP computerized systems, Pharmaceutical Inspection Cooperation Scheme (PIC/S) Guidance on Good Practices for Computerized Systems in regulated GxP environments
Security clearance eligibility required: Reliability Status with Site Access Security Clearance (SASC), which has a minimum requirement of 3 years of verifiable history in Canada, Australia, New Zealand, United States and/or the United Kingdom.Why CNL?Does working with a team across Canada to advance nuclear science and technology for a clean and secure world speak to you? We're reinventing ourselves to be the pace setters so we can lead the charge in solving the problems that matter, like building the next generation of clean nuclear and hydrogen energy solutions, developing new and better-targeted cancer treatments, and continuing to lead the world in environmental remediation.
  • Work-life balance is an integral part of our overall health and well-being; at CNL, we value this.
We offer a complete total rewards package :
  • paid time off (vacation, sick, floater & personal);
  • benefits effective day one, that’s right, no waiting period;
  • tuition support
  • and a pension!
Do Our Priorities Resonate with You?
  • Clean energy for today and tomorrow.
  • Restore and protect the Environment.
  • Contribute to the health of Canadians.
Location of Work - Hybrid
  • This role is based out of CNL’s Chalk River site, however, subject to the terms of this agreement, the primary work location will be remote. The role will require some regular and frequent attendance at the Chalk River site. The schedule and frequency will be determined by discussions with the manager as well as internal client and project needs. CNL may require travel from time to time, as necessary.
CNL is committed to providing an atmosphere free from barriers that promote equity, diversity and inclusion in achieving our mission. CNL welcomes and celebrates employees, stakeholders and partners of all racial, cultural, and ethnic identities.CNL also supports a workplace environment and a corporate culture built on our Core Values: Respect, Teamwork, Accountability, Safety, Integrity and Excellence, which encourage equitable employment practices and career prospects inclusive of accommodations for all employees.CNL is committed to being an equal-opportunity employer. If you require accommodation measures during any phase of the hiring process, please inform the Talent Acquisition Specialist with whom you are in contact. All information received in relation to accommodation requests will be kept confidential.The Chalk River Laboratories site is located on the unceded and unsurrendered territory of the Algonquin Anishinaabe people. As an organization, CNL recognizes and appreciates their historic connection to this place. CNL also recognizes the contributions that First Nations, Métis, Inuit and other Indigenous Peoples have made, both in shaping and strengthening this community in particular, and this province and country as a whole.

Canadian Nuclear Laboratories