OneLIMS Validation & Deployment Lead

Amaris Consulting

$110K *
Pharmaceuticals & Biotech
Less than 5 years of experience
Job Overview by Ladders

Qualifications

  • Extensive hands-on experience implementing enterprise LIMS solutions, preferably OneLIMS.
  • Experience delivering full LIMS implementation projects from scoping through deployment.
  • Strong background in Computer System Validation (CSV) within regulated GMP pharmaceutical environments.
  • Demonstrated experience defining and leading validation strategies.
  • Proven experience managing master data definition, verification, and system configuration.
  • Strong testing experience throughout the validation lifecycle, including planning, execution, and defect management.
  • Proven experience leading technical or cross-functional project teams, coordinating resources, assigning priorities, and driving successful project delivery.

Responsibilities

  • Lead pre-scoping workshops and translate business requirements into a clear deployment scope.
  • Define and drive the Computer System Validation (CSV) strategy in compliance with GMP requirements.
  • Own the definition, verification, and configuration of master data within OneLIMS.
  • Plan, author, execute, and coordinate testing activities across the validation lifecycle.
  • Manage defect resolution through to successful closure.
  • Lead and coordinate project team members within your workstream, providing technical guidance, setting priorities, and ensuring successful delivery.
  • Manage timelines, risks, dependencies, and stakeholder communication for your assigned workstream.

Benefits

  • Hybrid work model with 3 days per week on-site in Toronto, ON.
  • Opportunity to lead a crucial phase of a large-scale digital transformation in a highly autonomous role.
  • Exposure to cross-functional collaboration with Quality, Laboratory Operations, and IT teams.
  • Participation in a project aiming to enhance laboratory workflows and overall data management.
  • No Canadian work experience required, allowing diverse talent to apply.
Full Job Description
Job description

Join a large-scale laboratory digital transformation programme focused on deploying an enterprise Laboratory Information Management System (LIMS) across a regulated pharmaceutical environment.

The project is currently entering a pre-scoping phase following a programme reset. This role will play a key part in defining the deployment approach before moving into configuration, validation, testing, and implementation.

The solution supports the broader laboratory data model, extending beyond sample receiving to encompass multiple laboratory workflows.

This is a highly autonomous leadership role within a lean project team. There is no dedicated project manager overseeing individual workstreams, so each consultant is expected to independently lead their workstream from planning through delivery while also providing leadership and coordination to the team involved in its execution.
Location

Toronto, ON
Work Mode

Hybrid - 3 days per week on-site
Key Responsibilities
  • Lead pre-scoping workshops and translate business requirements into a clear deployment scope.
  • Define and drive the Computer System Validation (CSV) strategy in compliance with GMP requirements.
  • Own the definition, verification, and configuration of master data within OneLIMS.
  • Plan, author, execute, and coordinate testing activities across the validation lifecycle.
  • Manage defect resolution through to successful closure.
  • Lead and coordinate project team members within your workstream, providing technical guidance, setting priorities, and ensuring successful delivery.
  • Manage timelines, risks, dependencies, and stakeholder communication for your assigned workstream.
  • Act as the primary technical point of contact for Quality, Laboratory Operations, and IT teams.
  • Facilitate collaboration across cross-functional teams and drive alignment between business and technical stakeholders.
  • Support deployment activities and contribute to the successful implementation of the solution.
Required Profile
Must-Have Qualifications
  • Extensive hands-on experience implementing enterprise LIMS solutions, preferably OneLIMS or a comparable platform.
  • Experience delivering full LIMS implementation projects from scoping through deployment (not solely production support or maintenance).
  • Strong background in Computer System Validation (CSV) within regulated GMP pharmaceutical environments.
  • Demonstrated experience defining and leading validation strategies.
  • Proven experience managing master data definition, verification, and system configuration.
  • Strong testing experience throughout the validation lifecycle, including planning, execution, and defect management.
  • Proven experience leading technical or cross-functional project teams, coordinating resources, assigning priorities, and driving successful project delivery.
  • Demonstrated project management experience, with the ability to independently manage an entire workstream from planning through execution and reporting.
  • Strong leadership skills with the confidence to challenge plans constructively, influence stakeholders, and make decisions in complex project environments.
  • Excellent communication, stakeholder management, and problem-solving skills.
Nice-to-Have Qualifications
  • Previous experience supporting programme recovery or re-scoping initiatives.
  • Experience with laboratory processes beyond sample management, including:
    • Stability studies
    • Environmental monitoring
    • Quality Control (QC) laboratory workflows
  • Pharmaceutical or Life Sciences consulting experience.


Expected Compensation Range:
110K. The final compensation offered will be determined based on the candidate's level of experience, skills, and qualifications, in compliance with applicable pay transparency requirements.

Canadian Experience Requirement:
No Canadian work experience is required for this position. Candidates are encouraged to apply regardless of previous Canadian experience.

Artificial Intelligence (AI) Disclosure:
No Artificial Intelligence (AI) tools are used in the screening, assessment, or selection of candidates for this position. All stages of the recruitment process are conducted by human recruiters and hiring managers.

Statement Regarding Job Vacancy:
This position is a Job creation, created to support ongoing project needs.

Recruitment Process & Feedback Timeline:
Candidates will receive feedback on their application within a maximum of 45 days from the date of application or from their most recent interview stage.

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