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.

Requirements

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.

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 a
welcoming 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.