Computer System Validation Specialist (Hardware and Software)

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 View email address on ca.workus.org .

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.