Validation Associate

About the role

Canadian Blood Services is looking for a Regular Full-time and Temporary Full-time Validation Associate to join our dynamic Quality Assurance team.

The Quality Assurance team is accountable for the systematic efforts taken to assure that all Canadian Blood Services’ products and services delivered to the customer meets expectations of the customer.

In this role, you will provide technical leadership, guidance, and support to process teams. You will operationalize validation principles, ensuring the execution of the process will demonstrate changes to manufacturing and/or clinical services meet pre-defined requirements, safe-guarding patients’ safety and needs. You will also identify and promote continuous improvements, by establishing and analyzing process performance indicators, and by participating in investigations and quality metrics reviews.

As subject matter expert, you will manage validation projects, provide strategic inputs and technical guidance on validation requirements, and as required, assess validation resources, develop validation documents, execute validation activities, and recommends validation releases.

As a member of the Quality & Regulatory Affairs team, you will ensure that work performed is consistent with the overall strategic direction of the organization and is accomplished by working in collaboration with other members of the division and internal stakeholders.

Formula for success

• Leveraging your skills in technical leadership and strategic planning, you will develop validation strategies aligned with regulatory and quality management system requirements.

• Harnessing your knowledge of validation principles, you will ensure that planned changes in manufacturing and clinical services consistently meet safety, quality, and operational requirements.

• Employing your skills in generating validation deliverables, you will create plans, protocols, traceability matrices, and reports.

• Applying your skills in determining qualification and validation requirements, you will assess needs for new or modified equipment, facilities, systems, and processes.

• Leveraging your skills in educating process teams, you will foster effective relationships and ensure understanding within the quality management system context to meet biologics manufacturing and clinical service validation needs.

• Employing your skills in leading cross-functional process teams, you will guide validation projects and ensure their consistent application across the organization as subject matter experts.

Desired education and skills

• Post-secondary level education in a relevant discipline from a recognized academic institution, preferably a University Degree in Engineering or Sciences, or equivalent professional education.

• Minimum 3 to 6 years of progressive related experience, specifically in the field of validation and/or design control.

• Experience in pharmaceutical, medical device or biologic manufacturing under GMP regulation is required.

• Ability to use Microsoft Office as required.

• Experience with writing and executing validation plans, generating, and executing test protocols and preparing validation reports is essential. Specific experience in validation of facilities, manufacturing and laboratory equipment, computerized systems, software, methods, and processes, is considered a strong asset.

• Proven effective interpersonal, facilitation and English language communication skills and an ability to lead and work with multi-disciplinary teams.

What we offer you

• Defined benefit pension plan.

• Employee discounts, wellness program, professional resources.

What you can expect

• This role is required to be onsite at a Canadian Blood Services location 60% of the time/3 days of the week.

• This position will require you to travel 20-40% of the time.

• You will work Monday to Friday, 37.5 hours per week, 7.5 hours per day.

If this role resonates with you, we encourage you to apply by providing your up-to-date resume. This could be your first step towards a meaningful and inspiring career. Come to work each day knowing that you save lives.

We acknowledge that the work of Canadian Blood Services spans many Territories and Treaty areas across the country, and we are grateful for the Traditional Knowledge Keepers and Elders who have guided us in this important work. We recognize the land and waters that have inspired our work and offer gratitude to those Indigenous peoples on whose territory we work, live and play.

Diversity and inclusion play a vital role in ensuring health equity for patients across Canada. We are committed to reflecting Canada’s population in our organization and fostering an environment where all employees can be their authentic selves, with equal opportunities to succeed and contribute.

We thank all applicants for their interest. However, only those considered for an interview or those invited to participate in an assessment will be contacted. Emails are sent directly from our system, to ensure you receive them please add donotreply@blood.ca and system@successfactors.com to your safe senders list.

Applicants who require accommodation should discuss their needs with us.

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