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LIMS Support Specialist

Toronto, Ontario
Senior Level
full_time

About the role

About the job LIMS Support Specialist LIMS Support Specialist Quality Control (QC) We are seeking a LIMS Support Specialist to provide hands-on support to the Quality Control (QC) department. This role involves LIMS configuration, master data governance, and project support activities aligned with GMP and regulatory requirements.

Key Responsibilities LIMS Configuration & Technical Support

  • Customize and configure the LIMS platform to align with lab workflows, testing needs, and terminology.
  • Modify standard software code or develop new code to meet unique lab requirements.
  • Ensure user workflows, reports, and data elements are integrated without altering base code.
  • Serve as the LIMS System Owner, managing system changes and upgrades.

Data Governance & Compliance

  • Build and support a master data governance model for vaccine product specifications and analytical testing.
  • Ensure alignment with cGMP and data integrity requirements across QC instruments and systems.
  • Manage and maintain master specification documents for commercial products.
  • Oversee static master data for QC-LIMS, ensuring data accuracy, ownership, and semantic consistency.
  • Support audit readiness, regulatory inspections, and compliance-driven documentation.

Cross-Functional Collaboration

  • Work closely with internal QC teams, IT development teams, and global stakeholders.
  • Support the Data Logistics & Support (DLS) Department in meeting operational and project milestones.
  • Lead and contribute to LIMS master data management efforts for analytical testing portfolios.

Qualifications

  • Experience supporting or configuring LIMS platforms (LabWare, STARLIMS, or similar) in a GMP-regulated environment.
  • Familiarity with QC laboratory workflows, analytical testing, and regulatory compliance.
  • Strong understanding of master data governance and scientific data semantics.
  • Proficient in LIMS system ownership, change control processes, and cross-department coordination.
  • Excellent documentation, communication, and stakeholder engagement skills.

Note : Applicants must be eligible to work in Canada & US.

About PharmEng Technology

Pharmaceutical Manufacturing
201-500

PharmEng Technology is a leading global provider of technical services and solutions to the pharmaceutical, biotechnology, and healthcare industries. With over 25 years of experience, we specialize in Commissioning, Qualification, and Validation (CQV) services for facilities, utilities, equipment, and processes.

Our team of highly skilled professionals brings a wealth of industry expertise and knowledge to every project, ensuring that our clients receive the highest quality services and solutions. We pride ourselves on our ability to provide flexible, innovative, and cost-effective solutions that meet our clients' unique needs and challenges.

At PharmEng Technology, we are committed to delivering excellence in everything we do. We work closely with our clients to understand their goals and objectives and develop customized solutions that deliver measurable results. Our focus on quality, safety, and compliance ensures that our clients can trust us to meet their most critical needs.

As a trusted partner to some of the world's largest pharmaceutical companies, we have a proven track record of success in delivering high-quality technical services and solutions that drive operational efficiency, reduce costs, and enhance overall performance. We are dedicated to helping our clients succeed in an ever-evolving and highly competitive industry.

At PharmEng Technology, we are passionate about what we do, and we are committed to delivering excellence in everything we do.

Specialties: PharmEng Technology specializes in the planning, design, construction, and validation of Health Care, Laboratory, API Pharmaceutical and Biotechnology facilities and equipment, including computer systems. We provide professional services that meet both regulatory and business demands, following current Good Manufacturing Practices (cGMP), Good Engineering Practices (GEP), and Good Laboratory Practices (GLP).