- Position: Computer System Validation Specialist
- Location: API Headquarters (4000 – 10230 Jasper Ave), On-site
- Term: Permanent, Full-Time, On-Site
- Reporting Manager: Director, Project Management Office
We are actively seeking a highly skilled and motivated Computer System Validation (CSV) Specialist with applied validation Good Manufacturing Practice (GMP) experience gained from leading/supporting software system validation projects in the pharmaceutical and/or medical device industry. You need to bring best practice requirements from a proven track record in GMP CSV for Quality Management Systems (QMS) and have supported the onboarding of new hardware/software systems and their integration. If you have the ability to translate complex requirements into effective solutions, we invite you to explore this exciting opportunity with us.
As a Computer System Validation Specialist, you will collaborate with the Quality and Project teams to lead core Quality Management Systems (QMS), manufacturing/packaging, and engineering IT solutions. This involves analyzing requirements and specifications, addressing architecture needs, designing interfaces and integrations, configuring systems, conducting testing, and overseeing implementation.
Key Responsibilities, include but are not limited to:
Business Requirements and Process Definition
- Direct support to the implementation of electronic QMS solution for GMP operations in collaboration with Quality.
Software Validation Management
- Manage the validation full 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.
- 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 Compliance
- Ensure software solutions and systems used in GMP environments meet functional and user specification requirements. Develop, conduct, and document IQ, OQ, PQ activities.
- 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.
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.
Architectural Reviews and Governance
- Participate in architectural reviews, create design patterns, build policies and standards, and document these activities.
- Provide support to design governance activities of solutions and systems.
Qualifications (Education, Certification, Degree, Skills, Knowledge, etc.)
- A bachelor’s degree in business administration, Information Technology, Computer Science, or a related field, masters preferred.
- Certificate from International Institute of Business Analysts (or equivalent)
- 5 years of applied CSV experience in the pharmaceutical or medical device industry.
- 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.
- Able to drive requirements to closure and work with Quality 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 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.
- 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.
- Demonstrate analytical and conceptual problem-solving skills and the ability to synthesize and clearly communicate complex findings to various stakeholders.
- Required travel between Edmonton API sites.
Additional Required Documents to Support Application:
- Applications submitted without a resume AND cover letter will not be reviewed.
- Certificate from International Institute of Business Analysts (or equivalent)
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
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.
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.
Please send your cover letter and resume to the Human Resources email: firstname.lastname@example.org or apply below.
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.
Ready to get started? Apply now.
Please fill in the following form and attach a cover letter and CV. Please note that applications without a cover letter will not be considered.
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