We are looking to appoint a Temporary Associate Validation Specialist who will join the QA department on a full-time basis for up to one year from the summer 2025.
As part of a dedicated team, you will prepare complex installation and test validation procedures/protocols to ensure the product is manufactured in accordance with appropriate regulatory agency validation requirements, internal company standards and current industry practices. Compiles and analyzes validation data, prepares reports and makes recommendations for changes and/or improvements. Investigates and troubleshoots problems and determines solutions. Maintains validation documentation and files.
To be a successful in this role, you will perform validation projects activities for all facilities, equipment and processes operated in compliance with EurdraLex Volume 4 – Good Manufacturing Practice (GMP) guidelines requirements and other applicable quality system requirements, Ensure review and update of validation procedures (Policies, Master plans, SOP’s etc.) for equipment and facilities. You will establish and maintain Validation Plan; you will ensure that safe working methods and practices are adopted at all times and in accordance with Company policy for the safety of the post holder and others within the working environment. You will also prepare, execute and report validation protocol including cleaning validation, perform requalification and temperature mapping of refrigerators, freezers and incubators.
You will perform qualification studies on other equipment and processes. Establish and maintain the re-qualification schedule for validated equipment. You will liaise with Engineering, Quality Assurance and User Departments to ensure that validation is conducted in a timely manner according to the Validation Plan and with minimal disruption to production.
The successful candidate will have education and / or experience in some, or all, of the following areas:
- Knowledge of EudraLex Volume 4, including validation requirements for in Annex 11 and 15.
- Understanding of ISO 9001 and ISO13485 Quality Systems
- General understanding of IQ, QQ, PQ, PV
- Temperature mapping
- Cleaning validation
- Ability to author and execute validation reports
- Ability to write validation related procedures
- Understanding of calibration principles
If this sounds like the role for you, please apply for immediate consideration!
About us:
At Sekisui Diagnostics, we help improve patient outcomes by doing what we’ve always done – focusing on innovating and developing highly accurate diagnostics tests, reagents and systems. In recent years, social and consumer needs for medical care have been diversifying in line with dramatic transformations in the global medical environment. We will continue to embrace change and challenge new frontiers so that we can create unique, high-quality products and services that will leave our customers truly satisfied. With worldwide state-of-the-art manufacturing facilities and an international sales and distribution network, we are a solid partner for healthcare professionals, distributors, and manufacturers around the world. Our global capabilities allow us to meet the specific needs of our wide range of customers – and customize solutions at both a regional and product level.
Sekisui Diagnostics offers a competitive compensation and benefits package including a generous salary, participation in annual bonus plan, Company match to RRSP, education and fitness reimbursements and paid time off to volunteer.
Equal Opportunities
As an equal opportunity employer, Sekisui Diagnostics is committed to a diverse workforce. Employment decisions will be made without discrimination based on race, color, religion, national origin, gender, age, sexual orientation, physical or mental disability, genetic information or characteristic, gender identity and expression, veteran status, other non-job related characteristics or other prohibited grounds specified in applicable country and local laws. It is also Sekisui Diagnostics policy to comply with all applicable country and local laws respecting consideration of unemployment status in making hiring decisions.