Computer System Validation Manager

Saint-Laurent, QC, Canada

We are looking to grow our talented team with people who share our energy and enthusiasm to create
best pharmaceutical products for patients. Your expertise, combined with IntelGenx’s superior film
technologies and development and manufacturing capabilities, will help patients access next generation
pharmaceutical products.
Take this opportunity to advance your career with a leading drug delivery company focused on the
development and manufacturing of pharmaceutical films.

Job Description Summary:

The Computer Systems Validation Manager will be responsible for overseeing the validation of computer
systems in the manufacturing, warehouse and quality control areas to ensure compliance with Computer
System Validation (CSV) and Systems Development Lifecycle (SDLC).

Responsibilities:
 Provide direction and execution in Computer System Validation activities in the manufacturing,
warehouse, and quality control areas.
 Author and review computer validation related documentation including but not limited to: risk
assessments, validation plan, user requirements, specifications, traceability matrix, testing (FAT, SAT,
IQ, OQ/PQ), data migration, qualification/validation protocols and reports.
 Coordinate with other departments or outside contractors/vendors to complete validation tasks.
 Develop the CSV Plan and lead in the development of CSV policies, procedures and templates.
 Participate in regulatory audits and communicate company's computer validation policies.
 Prepare plans for remediation of legacy systems and implementation of new systems.
 Manage projects and prepare status reports as applicable.
 Solve problems during validation process and address/advise on issues such as deficiencies,
deviations and change control, etc.
 Ensure compliance of computerized systems to relevant regulatory requirements (e.g.
cGMP/GLP/GAMP/GALP).
 Plan and coordinate the implementation of new applications and software upgrades.
 Other duties, as required

Requirements:

 Bachelor’s degree in Engineering, Computers or related field.

 5+ years in a GMP regulated environment with related CSV industry experience (Pharma/Biotech).
Validation experience with ERP, LIMS, and Quality Systems preferred.
 Solid understanding of regulations, such as 21CFR Part 11, Good Automated Manufacturing Practice
(GAMP5), GLP and Good Automated Laboratory Practice (GALP)
 Strong attention to detail and compliance with strict adherence to procedures and protocols.
 Strong knowledge of computerized system development life cycle approach.
 Project management experience preferred.
 Effective communication and interpersonal skills to interface effectively with all levels of team
members, and with vendors, contractors and external customers.
We Offer
Competitive salary, annual bonus, health and dental insurance, summer hours program.
If you are interested in the job, please send you resume and cover letter to marie@intelgenx.com.
We are interested in every qualified candidate who is eligible to work in Canada.
IntelGenx is an equal opportunity employer and considers all qualified applicants for employment without
regard to race, color, religion, sex, gender, sexual orientation, gender identity, ancestry, age, or national
origin.

About IntelGenx:
IntelGenx is a leading drug delivery company focused on the development and manufacturing of
pharmaceutical films.
IntelGenx’s superior film technologies, including VersaFilm®, VetaFilm™ and transdermal, allow for next
generation pharmaceutical products that address unmet medical needs. IntelGenx’s innovative product
pipeline offer significant benefits to patients and physicians for many therapeutic conditions.
IntelGenx's highly skilled team provides comprehensive pharmaceuticals services to pharmaceutical
partners, including R&D, analytical method development, clinical monitoring, IP and regulatory services.
IntelGenx's state-of-the-art manufacturing facility offers full service by providing lab-scale through to pilot-
and commercial-scale production. For more information, visit www.intelgenx.com.