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Added 1 month ago
Specialist, Engineering
API
Edmonton, AB
Full-time
The successful candidate will support equipment across pharmaceutical manufacturing operations including filling systems, inspection equipment, autoclaves, process tanks, CIP/SIP systems,…
Added 3 days ago
Procurement Manager – Systems Track
Trillium Rail Partners
Mississauga, ON
Full-time
…the Procurement Manager will be responsible for developing and executing procurement strategies for complex rail and transit systems, equipment, materials, specialist services, and…
Added 1 month ago
Electronic Systems Specialist
Minnesota Direct Care and Treatment
Saint-Paul, NB · St.-Paul, NB
Full-time
In this position you will maintain, repair, and alter the data processing system connected to a group of state-owned buildings on the Capitol Complex in St. Paul. This processing system…
Added 9 days ago
Specialist, Utilities & Facilities Maintenance
Sun Pharmaceutical Industries Ltd
Brampton, ON
The Specialist, Utilities & Facilities Maintenance is responsible for ensuring the safe, reliable, and compliant operation, maintenance, and continuous improvement of facility…
Added 18 days ago
Mining Equipment Technical Specialist (Mechanical)
SMS Equipment Inc.
Elkford, BC
Full-time
SMS Equipment is looking for a Mining Equipment Technical Specialist (Mechanical) to support the timely repair of down mining equipment. Reporting to the Regional Reliability & QA Manager,…
Added 4 months ago
Junior Seating & Mobility Equipment Specialist
National Seating & Mobility
Dieppe, New Brunswick
Full-time
We are inviting qualified and motivated individuals interested in joining our British Columbia team as a Junior Seating & Mobility Equipment Specialist. We are currently hiring for our…
Added 3 days ago
Buyer - Systems Track
Trillium Rail Partners
Mississauga, ON
Full-time
Reporting to the Procurement Manager – Systems Track, the Buyer will be responsible for executing day-to-day purchasing activities for assigned systems, rail, equipment, materials,…
Added 4 months ago
Plumber/Maintenance Worker V
Fraser Health
BC · Tri-Cities / Coquitlam / Port Coquitlam / Port Moody, British Columbia
Full-time
Installs, troubleshoots, maintains, modifies, monitors, inspects, tests, repairs, replaces pipe and plumbing systems, medical gas systems, natural gas piping systems, appliances, equipment…
Added 1 month ago
Computer System Validation Specialist (Hardware and Software)
API
Edmonton, AB
Full-time · Temporary
Validate equipment including but not limited to the sterile filling line, rotating A/C systems, inspection machines, and analytical equipment (e.g., HPLC) by conducting IQ/OQ testing.
Added 1 month ago
Plumber/Maintenance Worker V
Fraser Health
Surrey, BC
Full-time
Installs, troubleshoots, maintains, modifies, monitors, inspects, tests, repairs, replaces pipe and plumbing systems, medical gas systems, natural gas piping systems, appliances, equipment…
Added 18 hours ago
Dental Equipment Sales Specialist
K-Dental Inc.
Montreal, QC
$90,000 to $100,000 CAD / year
Full-time
K-Dental is looking for a motivated and results-driven Dental Equipment Sales Specialist to join our team. As a Dental Equipment Sales Specialist, you will play a key role in driving growth…
Added 3 months ago
Equipment Specialist - Millwright
Thermo Fisher Scientific
Remote, Canada
Full-time · Remote
Perform general maintenance on production equipment such as: Fluid Bed Dryers, Film Coaters, Tablet Presses, Transfer Pumps, Vacuum Systems, Processing Vessels and auxiliary equipment.
Added 4 months ago
Junior Seating & Mobility Equipment Specialist - Abbotsford, Surrey, Tri-Cities & Vancouver
National Seating & Mobility
Abbotsford, British Columbia · Port Coquitlam, British Columbia · Surrey, British Columbia · Vancouver, British Columbia
Full-time
Junior Seating & Mobility Equipment Specialist - Lower Mainland, BC
Added 4 months ago
Seating & Mobility Equipment Specialist - Abbotsford, Surrey, Tri-Cities & Vancouver
National Seating & Mobility
Abbotsford, British Columbia · Port Coquitlam, British Columbia · Surrey, British Columbia · Vancouver, British Columbia
Full-time
Seating & Mobility Equipment Specialist - Lower Mainland, BC
Added 15 days ago
Field Technician Equipment Maintenance Specialist
AECOM
Vaughan, ON
$54,000 to $60,000 CAD / year
Full-time
AECOM is seeking a Field Technician Equipment Maintenance Specialist for a new position to be based out of our Vaughan, Ontario office and mapped to the Markham, Ontario office. This…
Added 1 day ago
Office and Administrative Specialist Intermediate
Minnesota Direct Care and Treatment
Saint-Paul, NB · St.-Paul, NB
Full-time
Use standard office software, equipment, and filing systems to complete daily work tasks.
Added 1 month ago
Seating & Mobility Equipment Specialist - Ottawa
National Seating & Mobility
Ottawa, ON
Full-time
As a Seating & Mobility Equipment Specialist, you will work closely with therapists, clients, and caregivers to assess mobility needs and recommend customized assistive technology…
Added 2 months ago
Desktop Systems Specialist
Teledyne Technologies Incorporated
Waterloo, Ontario · Canada - Waterloo, ON
Full-time
We are seeking a Desktop Systems Specialist to provide onsite and remote technical support for end users across hardware, software, mobile devices, and workplace technology. This role is…
Added 2 months ago
Seating & Mobility Equipment Specialist
National Seating & Mobility
Calgary, Alberta
Full-time
We are looking for a Seating & Mobility Equipment Specialist to join our sales team and help us continue our mission of transforming lives through mobility solutions.
Added 1 month ago
Embedded Systems Specialist II
Legrand Slovenija
Markham, ON
Full-time
Legrand has an exciting opportunity for an Embedded Systems Specialist II to join the Wattstopper/Vantage Team in Markham, Ontario. You will execute successfully on software/firmware…
Added 1 month ago
Ingénieur(e) électrique – Spécialiste en acquisition de données et instrumentation / Electrical Engineer – Data Acquisition and Instrumentation Specialist
RTX
Longueuil, QC
Full-time
…d’aéronefs de nouvelle génération qui propulsent la plus grande flotte mondiale d’avions et d’hélicoptères dans les segments de l’aviation d’affaires, de l’aviation générale et de…
Added 1 month ago
Ingénieur(e) électrique – Spécialiste en acquisition de données et instrumentation / Electrical Engineer – Data Acquisition and Instrumentation Specialist
Pratt & Whitney
Longueuil, QC
Full-time
…d’aéronefs de nouvelle génération qui propulsent la plus grande flotte mondiale d’avions et d’hélicoptères dans les segments de l’aviation d’affaires, de l’aviation générale et de…
Added 2 months ago
Specialist, IT Planning & Business Partnership – Mineral Processing and Technical Research & Innovation Systems
Vale
Toronto, Ontario
Full-time
From utensils to cellphones to satellites, our operations simplify daily life and enhance connectivity. Our metals are integral to life-saving medical equipment and the electric vehicles…
Added 10 days ago
Technology, Reports and Data Specialist - Management Analyst 3
Minnesota Direct Care and Treatment
Saint-Paul, NB · St.-Paul, NB
Full-time
Provide support, tips, and instruction for division software, computer equipment, and MCHP computer systems, etc.
Added 5 days ago
Cultivation Systems Specialist
Rubicon Organics™
Delta, BC
$60,000 to $70,000 CAD / year
Full-time
The Cultivation Systems Specialist is responsible for the day-to-day execution of the established plant nutrition, and root zone programs across the greenhouse production compartments and…

API

Computer System Validation Specialist (Hardware and Software)

Edmonton, AB, T6N 1H1, Canada

Job type: Full-time · Temporary
Experience: 3-5 years of applied CSV experience in the pharmaceutical or medical device industry with a broad base of working with various computerized systems.
Posting language: English
Posted: Jul 27, 2026

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Original job description

Applied Pharmaceutical Innovation (API) brings life-saving research to the real world by helping life science innovators bridge the gap between academic research and commercial product development. We are driven, compassionate, and laser focused on making a dramatic positive impact with everything we undertake.

When you join API, you are part of a rapidly growing team that is creating collaborative opportunities to commercialize Canadian life sciences discoveries, increasing the amount of commercial research and development in the country, and supporting Alberta as a key pillar in Canada’s life sciences sector.

You will be part of one of API's most important projects, the Canadian Critical Drug Initiative (CCDI). The CCDI is a project led by API in partnership with the University of Alberta. It aims to establish an integrated research, commercialization, and manufacturing cluster in the Edmonton Metropolitan Region.

One aspect of the project involves upgrading the Biotechnology Business Development Centre (BBDC) in the Edmonton Research Park. The upgrade will include GMP-certified manufacturing suites for API-manufacturing, chemical-physical testing, and Health Canada-approved warehousing capacity.

The second part of the project is the Critical Medicines Production Centre (CMPC), which will be a new 83,000+ square-foot manufacturing facility located on a 7-acre plot of land in the center of the Edmonton Research Park. This facility is set to be Canada’s largest and best-equipped of its kind. The CMPC's focus will be on producing small-molecule product solutions, conducting sterile, aseptic fill, and finishing traditional and biologic drugs to meet drug shortages needs.

This is a full-time temporary 15 month contract with an expected end date of November 2027.

** Please note this position requires full-time on-site presence.

Support for GMP Operations:

Implementation & qualification of electronic QMS solution including new material management system, LIMS and environmental monitoring systems
Procurement, implementation & qualification of GMP electronic solutions (e.g. building automation system (BAS), manufacturing and research lab equipment).
Overseeing facility operations and maintenance of processes, controls, equipment, and instrumentation.
Validate equipment including but not limited to the sterile filling line, rotating A/C systems, inspection machines, and analytical equipment (e.g., HPLC) by conducting IQ/OQ testing.
Serve as the point of contact for IT qualification and CSV activities, ensuring proper integration within the overall project plan under supervision of internal stakeholders.

Software and Hardware Validation Management:

Manage the full validation lifecycle of software systems, ensuring they operate in compliance with cGMP, 21CFR11, GAMP5 requirements.
Work with Quality and Engineering to generate lifecycle CSV deliverables for each electronic system, including validation assessments and plans, risk assessments, software and configuration testing, reporting, and change management.
Responsible for the CSV of new corporate electronical systems for example financial ERP-systems or electronical systems for other departments
Manage validation documentation and records and ongoing change management and qualification requirements to cGMP, 21CFR11, and internal API procedural requirements.
Be accountable for computerized system change control.
Be the technical subject matter expert to provide guidance on CSV documentation requirements and approaches. Provide support as needed for audit purposes.

Quality Assurance and Compliance:

Ensure software solutions and systems used in GMP environments meet functional and user specification requirements.
Prepare User Requirements Specifications (URS) with considerations of the IT Infrastructure, including server structure.

Develop, conduct, and document IQ, OQ, PQ activities for IT hardware and software. Ensure solutions and systems are implemented, monitored, and thoroughly traceable to all aspects of GMP operations and production in accordance with audit controls and regulations.
Document validation protocols, test results, and deviations, and lead remediation actions.

Risk Planning and Analysis:

Support business continuity and disaster recovery risk planning pertaining to electronic systems.
Gather data and analyze GMP solution and system utilization; propose improvements, as needed.

Corporate ERP Validation

Develop and execute ERP system, validation protocols to ensure compliance.
Collaborate with cross-functional teams to define business requirements and align ERP functionality with validated processes.
Maintain validation documentation.

Education

Bachelor’s degree in engineering and/or information technology, computer science, or a related field from a recognized program in Canada.

Experience:

3-5 years of applied CSV experience in the pharmaceutical or medical device industry with a broad base of working with various computerized systems.
Expertise in the application of Health Canada and FDA GMP requirements including 21CFR11, GAMP 5 guidance pertaining to highly complex automated electronic systems for Quality and manufacturing/packaging and engineering operations.
Expertise in electronic quality management systems (QMS), QMS product management, and systems validation.
Experience in driving requirements to closure and working with Quality team to develop guidelines and procedures to formalize and educate colleagues on needs and expectations of data integrity, ALCOA+.
Excellent knowledge in system integration methodologies and tools.
Proven experience in developing and executing plans, meeting deadlines, and operating under tight time constraints.
Good understanding of hardware and software development tools and languages.
Good understanding of development languages, development tools, and the System Development Lifecycle.
Good understanding of relational databases and designing data structures for use by applications and users.
Current knowledge of industry best practices, best-of-breed applications.
Demonstrate analytical and conceptual problem-solving skills and the ability to synthesize and clearly communicate complex findings to various stakeholders.

Personal Competencies

Strong customer focus with a demonstrated ability to work seamlessly with business sponsors and technologists.
Exhibits curiosity, a commitment to learning, and exploring new technology.
Fosters a transparent, honest, and positive team environment.
Results-oriented and process-driven, with high expectations of self and the team.
Excellent communication skills with demonstrated experience in making articulate and effective oral presentations to different audiences.
Ability to build constructive business relationships and gain the trust of others.
Proven ability to lead, persuade, and influence.
Must be self-confident, outgoing, and able to communicate effectively with management and staff.

Working Conditions:

This position requires on-site presence.
Exposure to production environment
Work in production and office settings.

Additional Required Documents to Support Application

Applications submitted without a resume AND cover letter will not be reviewed.
Please attach relevant certifications or designations

Perks and Benefits at API

Comprehensive Health Coverage: At API, we prioritize the well-being of our employees. We offer a comprehensive health coverage plan. Our premiums are 100% covered, ensuring that you and your dependents receive the necessary healthcare support.

Retirement Savings: API offers a RRSP Matching Program. Employees may be eligible to participate, with API matching of contributions up to 1–3% of base salary, in accordance with program terms.

Professional Development Opportunities: We foster a culture of continuous learning and growth. API provides access to various professional development opportunities, including training programs, workshops, conferences, and certifications. We encourage employees to enhance their skills, broaden their knowledge, and stay updated with the latest advancements in the life sciences industry.

Collaborative and Inclusive Environment: At API, we believe in the power of collaboration and diversity. We foster an inclusive work environment that values and respects individuals from all backgrounds. We promote teamwork, open communication, and a supportive atmosphere where everyone's contributions are valued.

Generous Paid Time Off: We understand the importance of taking time off to recharge and maintain a healthy work-life balance. API offers a generous paid time off (PTO) policy that includes vacation days, medical/personal days, and holidays. We encourage our employees to prioritize their well-being and enjoy quality time away from work.

Green Transit Allowance: Employees based out of an office are eligible to enroll in our green transit program, which promotes the use of environmentally friendly modes of transportation. By participating in the program, you commit to making green transit your primary mode of transportation for at least 75% of your commute to and from work. Green transit includes walking, biking, carpooling, and public transportation.

Work From Home: Eligible employees are entitled to 20 Work from Home days, this is subject to job function, company needs, and manager approval.

How to Apply

Interested applicants must submit a resume and cover letter expressing their interest in the position and why they believe they are a strong candidate.

We appreciate all applicants' interest and will only contact those selected for interviews.

If you have any questions about the application process or require accommodations during the hiring process, please contact [email protected].

Our team, clients, and stakeholders come from a variety of backgrounds. In recruiting for our team, we welcome the unique contributions that all people bring to the workplace in terms of varied lived experiences, education, culture, gender, race, sexual orientation, religious or ethnic background, neurodiversity, and cognitive and physical ability.

Before employment, successful candidates will be required to meet the requirements of a pre-employment screening, which includes background reference checks, educational credential verification, and criminal reference checks.

This position will remain open until filled.

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More about this job

Responsibilities

Manage the full validation lifecycle of hardware and software systems to ensure compliance with cGMP, 21CFR11, and GAMP5 requirements. Oversee facility operations, equipment qualification, and the implementation of electronic quality management and manufacturing systems.

Requirements

Requires a bachelor's degree in engineering, information technology, or computer science. Candidates must have 3-5 years of applied CSV experience in the pharmaceutical or medical device industry.

Skills

Computer System Validation
cGMP
21CFR11
GAMP 5
Quality Assurance
Hardware Validation
Software Validation
ERP Systems
Data Integrity
ALCOA+
System Integration
Risk Assessment
IQ/OQ/PQ
LIMS
Building Automation Systems

Benefits

Comprehensive health coverage
RRSP matching program
Professional development opportunities
Paid time off
Green transit allowance

Visa sponsorship

Not detected in the job text

Keywords

Computer System Validation
cGMP
21CFR11
GAMP 5
Pharmaceutical
Medical Device
ERP
LIMS
IQ/OQ/PQ
Data Integrity
ALCOA+
Quality Assurance
Validation Lifecycle
Change Management
Risk Assessment
Building Automation System
Hardware Validation
Software Validation
System Integration
Technical Operations
Engineering
Compliance
Biotechnology
Manufacturing
Analytical Equipment
HPLC
Business Continuity
Disaster Recovery
Health Canada

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