Validation Specialist

Why join our team?

Think you have what it takes to work in an organization where creativity, drive and ambition are valued while integrity motivates everything we do?

Medicomhas been in business for over 35 years, and it has kept its entrepreneurial mindset. Working with us, you will have the opportunity to get involved, have an impact, and contribute to the company’s continued growth. We live by our values every day, focussing on customer satisfaction while ensuring teamwork, accountability, and empathy in everything we do.

Our team loves challenges and a fast-paced environment. You will have the flexibility to manage work and a personal life, as well as your own personal well-being. We offer an attractive compensation package with benefits.

The Opportunity

As Validation Specialist, you will design and execute comprehensive validation protocols, while ensuring compliance with regulations and quality standards.

What you will do

• Perform thorough testing to ensure data integrity and reproducibility.
• Analyze test results, identify potential issues, and propose improvement solutions.
• Thoroughly document validation activities and produce detailed reports on the obtained results.
• Optimize the validation program established at Medicom and provide coaching and training on validation principles to team members.
• Establish validation standards and develop performance testing and quality control measures.
• Calibrate, or coordinate the calibration of, equipment to ensure they function within acceptable parameters.
• Update and maintain the validation master plan for the North American facilities and manage, coordinate, and guide the execution of the VMP, while ensuring that the processes, equipment, facilities, and utilities remain in an appropriate validated state.
• Lead and / or execute validation projects and complete all associated project documentation in line with regulatory expectations.
• Provide the relevant support for regulatory audits, submissions, and other auditor requests.
• Develop and write commissioning, qualification, and validation documents, including (but not limited to) commissioning test scripts, qualification protocols and reports, and risk assessments. Maintain all associated records.
• Analyze test data to determine the causes of defects, failure, or flaws and facilitate corrective measures.
• Perform risk assessments when necessary and ensure compliance with industry standards.
• Ensure all systems run efficiently and correctly to produce high-quality products.
• Train staff on validation parameters.
• Other related duties/responsibilities as required or assigned by the Manager.

What you will bring

• A minimum of 10 years of progressive experience in a GMP (Good Manufacturing Practices) environment, in the pharmaceutical or medical devices industry, or closely related field.
• A minimum of 7 years experience conducting IQ / OQ/ PQ activities.
• Able to travel up to 30% of the time to the North America sites (St-Laurent, Pointe-Claire, St-Eustache & Georgia in USA).
• Minimum DEC in a scientific field.
• Detail oriented, accurate and reliable.
• Solution oriented.
• Good written and verbal communication skills in both English and French.
• Ability to make sound quality decisions.
• Ability to work in a dynamic environment with multiple priorities and meet deadlines.
• Demonstrate the Medicom core values of Teamwork, Accountability and Customer Centricity.

The following would be an asset:

• Knowledge of ISO standards and regulatory requirements for medical devices (Canada and USA).
• Knowledge of Good Manufacturing Practice (GMP) requirements.
• Certificate in Quality Assurance or knowledge of Root Cause Analysis methodology.
• Technical knowledge of similar types of medical devices.

What we offer

• Competitive salary.
• Comprehensive insurance program including EAP and telemedicine for you and your family.
• Pension plan with company matching.
• Possibility of a hybrid work schedule, with home internet and office expense allowance.
• We value and encourage our people to focus on improving themselves, their knowledge, and their skills. As such we have an environment where we provide a lot of training, coaching and professional development opportunities.
• Fun work atmosphere, an active social committee that organizes fun activities such as sports, BBQs, family events and more!

Equal Opportunity Employer

Medicom is an equal opportunity employer. We consider all applicants without regard to age, gender, gender identity or expression, sexual orientation, race, ethnic or national origin, religious beliefs, sex (including pregnancy and breastfeeding), disability or marital or family status. We welcome applications from all qualified individuals and encourage Indigenous persons, persons of color, LGBTQ+ and gender-nonconforming persons, persons with disabilities, women, and members of any other marginalized group.

If you are energetic, committed to making a difference and love challenges, we would love to hear from you. Visit our website at https://medicom.com/en_ca/careers/ and apply today!