Validation Specialist

Catalyx; Montreal (administrative region); On-site; CAD 90,000 - 120,000; Full time

Job summary

Catalyx is seeking an Equipment and Systems Validation Specialist to lead qualification activities for pharmaceutical equipment and systems in Montreal, QC.

You will write IQ/OQ/PQ protocols, execute or supervise testing, manage protocol reviews and documentation, participate in deviations and change controls, contribute to internal audits, and collaborate with project engineering, ensuring compliance with regulatory standards using SAP and TrackWise.

Qualifications

• Bachelor’s degree or higher in Engineering or related field.
• Bachelor’s degree or higher in Science or related field.
• Minimum 5 years of experience in the qualification of equipment used in pharmaceutical manufacturing.
• Minimum 3 years of experience in the pharmaceutical industry.

Responsibilities

• Write validation protocols for IQ, OQ, and PQ.
• Execute or supervise the execution of protocol testing.
• Manage the review and approval process of protocols.
• Manage documentation related to validation activities (filing, updating, and preparation).
• Participate in the resolution of deviations and deficiencies.
• Participate in the assessment and updating of change controls for validated systems.
• Participate in audits as a validation subject matter expert.
• Participate in regular validation team meetings.
• Assist/support the documentation team in the preparation of SOPs.
• Write technical notes as required.
• Work closely with the project engineering team.
• Perform periodic requalifications, including but not limited to sterilization and depyrogenation cycles.

Skills

Bilingual English/French

Education

Bachelor’s degree in Engineering

Bachelor’s degree in Science

Tools

SAP

TrackWise

Job description

Catalyx is looking for an Equipment and Systems Validation Specialist to participate in the qualification and requalification of complex equipment and systems.

Responsibilities

• Write validation protocols for Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ).
• Execute or supervise the execution of protocol testing.
• Manage the review and approval process of protocols.
• Manage documentation related to validation activities (filing, updating, and preparation).
• Participate in the resolution of deviations and deficiencies.
• Participate in the assessment and updating of change controls for validated systems.
• Participate in audits as a validation subject matter expert.
• Participate in regular validation team meetings.
• Assist/support the documentation team in the preparation of Standard Operating Procedures (SOPs).
• Write technical notes as required.
• Work closely with the project engineering team.
• Perform periodic requalifications, including but not limited to sterilization and depyrogenation cycles.

Skills, Knowledge, and Abilities

• Fluency in English and French (spoken and written): the position holder will collaborate with regulatory authorities, suppliers, and/or clients located outside the province of Quebec and will be required to read and write documentation exclusively in English as part of their duties. .
• Knowledge of SAP, TrackWise, and other electronic document management systems is an asset.

Education (Required)

• Bachelor’s degree or higher in Engineering or a related field.
• Bachelor’s degree or higher in Science or a related field.

Experience (Required)

• Minimum of 5 years of experience in the qualification of equipment used in the manufacturing and/or packaging of various pharmaceutical dosage forms (OSD – Oral Solid Dosage and injectables), as well as critical systems (HVAC, purified water, compressed air).
• Minimum of 3 years of experience in the pharmaceutical industry.

Why Join Catalyx?

At Catalyx we understand that our people are our greatest asset. For this reason and many others, we take care of them. The team in Catalyx benefits from a Total Rewards package. This includes great personal benefits and professional growth opportunities.

• At Catalyx we understand that our people are our greatest asset. For this reason and many others, we take care of them. The team in Catalyx benefits from a Total Rewards package. This includes great personal benefits and professional growth opportunities.

Catalyx is an Equal Opportunity Employer. We are committed to creating a diverse and inclusive workplace where all individuals are valued, respected, and supported. We do not discriminate on the basis of race, color, religion, sex (including pregnancy, gender identity, and sexual orientation), national origin, age, disability, veteran status, genetic information, or any other characteristic protected by applicable law. We encourage applications from all qualified candidates, regardless of background, and strive to create awelcoming environment for everyone.

At Catalyx, we are committed to attracting the best global talent. We proudly support our international employees by offering assistance with Critical Skills Visa applications for eligible candidates.