PharmEng Technology has been providing quality services to leading manufacturers of healthcare and pharmaceutical products since 1997. Our specialists hold expertise in Commissioning & Qualification, Validation, Quality Systems, Regulatory Affairs, Engineering, and Training to ensure that our clients can keep on providing the world with their cost-effective and high-standard healthcare products.
At PharmEng Technology, we strive to cultivate the best working environment where empowerment, passion and perseverance are nurtured while serving our clients to achieve their unique business goals.
We are seeking a highly skilled and technical LIMS Specialist with a strong understanding of cGMP (Good Manufacturing Practices) to join our team in Toronto, Ontario. This role requires an individual who is not only adept in programming and system customization but also has a solid grasp of data governance, data integrity, and compliance within a pharmaceutical or biotech environment.
Responsibilities:
Program & Portfolio Management:
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Act as the LIMS System Owner, coordinating and overseeing the delivery of system changes and evolutions in partnership with a global team.
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Manage relationships with internal business customers and related IT development and support teams.
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Develop, maintain, and modify the analytical testing portfolio through LIMS master data management processes.
Data Governance:
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Build and support the current and updated master data governance model for vaccine product specifications and analytical testing.
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Foster transparent sharing of scientific and testing data semantics through a common internal reference model.
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Support the Data Logistics & Support (DLS) Department, ensuring delivery of project and operational objectives.
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Understand the cGMP requirements for data collection models from testing performed using various QC laboratory instruments, TCU, and related computerized systems.
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Support the activities related to maintaining all commercial product master specification documents for Industrial Affairs.
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Ensure that data transfer and software update related activities for the QC-LIMS system and related processes are maintained in compliance with site needs and regulatory requirements.
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Manage static master data relating to QC-LIMS, ensuring data ownership, integrity, quality, and transversal reuse of data semantics.
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Support activities related to the regulatory inspections and internal audits determined by the program leader.
Technical Expertise:
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Customize and configure LIMS to meet specific laboratory requirements, workflows, and processes.
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Adapt procedures through modifications to the standard software code or by writing new code from the ground up.
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Configure functional components of the LIMS to create solutions that meet user requirements without altering the standard code.
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Ensure that LIMS adjustments align with user needs concerning workflows, report formats, data components, terminology, and other aspects.
Requirements:
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Bachelor’s or master’s degree in computer science, Information Technology, or a related field.
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Extensive experience in LIMS customization and configuration within a pharmaceutical or biotech environment.
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Strong understanding of cGMP and regulatory compliance requirements.
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Proficiency in programming languages relevant to LIMS customization.
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Excellent project management and organizational skills.
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Ability to work collaboratively with cross-functional teams and manage relationships with internal stakeholders.
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Experience in data governance and maintaining master data integrity.
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Familiarity with testing data models for managing data generated by QC laboratory instruments, TCU, and computerized systems.
Preferred Qualifications:
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Previous experience working with LAB MASTER or similar clinical laboratory software.
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Knowledge of integrated quality management systems for management of master data.
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Experience in participating in regulatory inspections and internal audits is a bonus.
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Strong communication skills and the ability to foster transparent sharing of scientific and testing data semantics.
Why PharmEng Technology?
Our consultants come from different areas of the Pharmaceutical/Biotech/Medical Device industries and have extensive experiences obtained from world-class organizations in North America, Europe, and Asia. At PharmEng Technology, we value everyone’s unique talents and work together to support our clients. We offer continuous career growth, competitive wages, opportunities for travel and a team mentality that sets us apart from our competitors. It is the growth of our staff that continues to grow our company globally.
What We offer:
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Comprehensive benefits package & competitive wages.
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A supportive environment where employee growth is promoted.
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Paid holidays.
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Other great incentives.
EEOC Statement:
At PharmEng Technology, we don’t just accept difference — we celebrate it, we support it, and we thrive on it for the benefit of our employees, our clients, and our community. PharmEng Technology is proud to be an equal opportunity workplace.
Thank you for your consideration and application! We review all resumes and submissions, however, due to the sheer volume of requests that we receive, only successful candidates will be contacted.
