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Job summary

Work environment

Description

This position will be a member of the implementation team and principal application support of the Laboratory Informatic Management (LIMs) system post go live.  This includes the configuration, customization, security, integrity and on-going support of all functional user groups.  As a strong partner with the business, this position understands the business challenges and opportunities.  This position will lead the configuration and maintenance of value added solutions to meet the user requirements and reporting needs of the business.  Additionally, this position is responsible for troubleshooting and problem resolution, management of system resources, internal user performance, support and maintenance of all system environments, as required.

This position will collaborate with internal Laboratory Subject Matter Experts (e.g. Analytical Chemists, Scientists, and Quality analysts), IT, and Engineering personnel in a global environment.  Additionally, this role will work with vendor based consultants and services to ensure continued operation of the LIMs system and interfaces to other systems (e.g. ERP).  This role requires strong technical skills, familiarity with LIMs and relational databases, as well as, extensive problem solving skills.  They will also need to have a good understanding of laboratory processes and instrumentation utilized. This role will manage the design, development, implementation and on-going support of this and other business applications.

Tasks/Responsibilities

As the IT subject matter expert of the LIMs system and other systems, as assigned, this position will:

  • Analyze business process issues and improvement opportunities to understand requirements and provide solution recommendations to the business and IT management as needed to optimize the use of the LIMs application and improve the end user experience.
  • Document and assist users in defining business requirements, process maps and use cases.
  • Investigate feature requests, clarify user requirements and objectives, understand software functionality and recommend appropriate solutions to drive business effectiveness and efficiency.
  • Develop user training materials and deliver end user training.
  • Develop a system road map which aligns to the business strategy.
  • Provide expert advice to the business in best use of LIMs system functionality. Verify data integrity, functional integrity testing and data maintenance.
  • Fulfill ad-hoc business reporting needs and assist with interpretation of data.
  • Ensure business applications comply with relevant standards and regulations.
  • Work with IT and external Vendor(s) to document and ensure Disaster recovery capability.
  • Have a complete understanding of the system architecture and infrastructure components.
  • Ability to undertake LIMs system patch management and upgrade planning/execution.
  • Responsible for installation new application features or liaising with vendor for installation related activities (new implementations and standard upgrades).
  • Manage changes under change control to ensure system remains in a state of validation/regulatory compliance in line with site and corporate documentation, as well as, regulatory requirements.
  • Identify integration points with other systems (e.g. ERP, Document Management, and Laboratory Equipment) and understand the technical architecture.
  • Support data exchange activities with interfaced systems.
  • Provide end-user application support on-demand including troubleshooting and resolution; make decisions that best resolve product related issues and appropriately escalate issues that require IT and/or business management involvement.
  • Ensure data management and back up plans are executed.
  • Test and analyze new product specifications and analysis methods as per the change request process.
  • Develop and document support plans for laboratory systems.
  • Interact with Service Desk to coordinate support activities and application knowledge transfer.
  • Proactively raise technology related risks, issues, and opportunities. Develop and maintain documentation of applications, including process workflow diagrams, detailed business requirements and reports, etc.
  • Create test plans for implemented software and provide training on software changes when appropriate.
  • Manage assigned projects and ensure changes conform to the company Policies, Standard Operating Procedures (SOPs), Work Instructions (WIs) and other documentation.
  • Support the organization in maintaining a work environment focused on quality, fosters learning, respect, open communication, collaboration, integration, and teamwork.
  • Understand current metrics and defines Key Performance Indicators (KPIs) to support departmental and company objectives.
  • Support Audits and Periodic Review processes as required.
  • Ensure adherence to OLA’s with the business and vendor SLA’s.
  • Adherence to Project timelines and budgets.
  • Other duties as assigned.

Requirements

Level of education

University

Diploma

BAC
Completed

Work experience (years)

10+ years

Written languages

Fr : Advanced
En : Advanced

Spoken languages

Fr : Advanced
En : Advanced

Requested skills

Required Competencies:
  • Prior experience with Thermo-Fisher Sample Manager LIMs systems or similar LIMs system.
  • Knowledge of architecture for the laboratory systems including ELN and LIMS.
  • Experience working in the biotech/pharmaceutical manufacturing industry is preferred.
  • Familiarity in working with validated systems and working within the Computer System Validation Framework.
  • Must possess strong knowledge of laboratory technology systems development life cycle, computer systems validation, application development or systems integration.
  • Interpersonal skills necessary to form effective relationships with the user community, IT colleagues and external vendors.
  • Experience working both independently and in a team-oriented, cross-functional collaborative environment is essential.
  • Ability to elicit cooperation from a wide variety of persons in different departments
  • Ability to communicate ideas in both technical and user-friendly language at all levels of the business.
  • Strong written and oral communication skills.
  • Ability to comprehend, interpret, and comply with company policies and procedures.
  • Experience developing documents for business requirements and process workflow diagrams.
  • Working knowledge of 21CFR part 11 requirements and direct experience with systems implementation in a validated environment.
  • Flexibility to adjust to changing priorities.
  • A demonstrated ability to modify or improve analytical instruments to address specific analysis challenges. A demonstrated ability to lead projects, demonstrate results and drive projects to completion.
  • Superior judgment and analytical skills to make effective decisions leading to product/project success.

Desired Skills:

  • Strong technical aptitude and the ability to learn new processes and systems quickly.
  • Must be able to work independently, as well as, in a team.  Be able to effectively manage multiple priorities and solve complex problems.
  • Excellent organizational skills with strong analytical and quantitative background.
  • Must be self-motivated and directed, can think critically, as well as, possess effective presentation and negotiation skills to manage a broad range of stakeholders.
  • Knowledge of SQL, VB or any programming experience is a plus.
  • Experience with Integration Manager is a plus.
  • Knowledge of Vacuum Generator Language (VGL) coding language a plus.

Work Requirements:

  • Overtime may be required.
  • Sitting for extended periods of time, up to 6 hours a day; walk, reach with hands/arms and stoop, kneel, crouch, or crawl.
  • Dexterity of hands and fingers to operate a computer keyboard, mouse, and other devices and objects.
  • Lifting and transporting of approximately 20 lbs Physically able to participate in sessions, presentations, and meetings.
  • Some travel may be required.

Education:

  • Bachelor of Science degree in Computer Science, Information Technology or relevant engineering required.
  • 10 years’ experience with business systems analysis and architecture. Biotechnology and/or Pharmaceutical industry experience a plus.  Three plus years’ experience working with Sample Manager LIMS or similar LIMS system.


Benefits

  • Deferred profit sharing plan DPSP

    Pour les postes permanents après 6 mois de service

  • Deferred profit sharing plan DPSP

    Pour les postes permanents après 6 mois de service

  • Dental insurance Pour les postes permanents après 3 mois d'embauche.
  • Dental insurance

    Pour les postes permanents après 3 mois d'embauche.

  • Disability insurance Pour les postes permanents après 3 mois d'embauche.
  • Disability insurance

    Pour les postes permanents après 3 mois d'embauche.

  • Employee assistance program Pour les postes permanents après 3 mois d'embauche.
  • Employee assistance program

    Pour les postes permanents après 3 mois d'embauche.

  • Flexible hours
  • Flexible hours

  • Floating leave days Pour les postes permanents après 6 mois d'embauche.
  • Floating leave days

    Pour les postes permanents après 6 mois d'embauche.

  • Life insurance Pour les postes permanents après 3 mois d'embauche.
  • Life insurance

    Pour les postes permanents après 3 mois d'embauche.

  • Medical and paramedical expenses coverage Pour les postes permanents après 3 mois d'embauche.
  • Medical and paramedical expenses coverage

    Pour les postes permanents après 3 mois d'embauche.

  • On-going training
  • On-going training

  • Performance bonuses Pour les postes permanents.
  • Performance bonuses

    Pour les postes permanents.

  • Registered retirement savings plan Pour les postes permanents après 6 mois d'embauche.
  • Registered retirement savings plan

    Pour les postes permanents après 6 mois d'embauche.

  • Social activities organized by the company Plusieurs activités organisées: Noël, BBQ, Défi Entreprise, journée au hockey, au baseball ou au football, pool de hockey ... et beaucoup de plaisir!
  • Social activities organized by the company

    Plusieurs activités organisées: Noël, BBQ, Défi Entreprise, journée au hockey, au baseball ou au football, pool de hockey ... et beaucoup de plaisir!

  • Travel insurance Pour les postes permanents après 3 mois d'embauche.
  • Travel insurance

    Pour les postes permanents après 3 mois d'embauche.

  • Vision care insurance Pour les postes permanents après 3 mois d'embauche.
  • Vision care insurance

    Pour les postes permanents après 3 mois d'embauche.