Validation Specialist

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.