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Herakles Pharma

Lab Services Equipment Life Cycle Specialist

Locatie:Leiden
Werkweek:40 uur
Procedure: Detachering
Vacature ID:#523
Publicatiedatum:09-01-2018

Lab Services Equipment Life Cycle Specialist

De organisatie

This job at the One Lab Laboratories at Janssen Biologics B.V. will give you a wonderful opportunity! The One Lab Laboratories is a combined lab existing out of several test labs.The specified test labs are divided based on specific techniques and/or expertise. All test labs are supported by a Lab Service team. The Lab Service team consists out of specialized sub teams: Automation, Change Control & Deviations, Compliance and Equipment Life Cycle Management.

De functie

Responsibilities of Lab Services Equipment Life Cycle Specialist.

The specialist:

  • Plans, schedules, coordinates, tracks and prioritizes all facets of buying, installing and validating (new) lab equipment, also directs, supports and oversees testing efforts, executes protocols for installation, operational and performance qualification testing, reviews data, generates documentation and reports;
  • Interacts with contract manufacturers;
  • Performs, coordinates and assists in various quality functional areas and maintains expertise. Conducts investigations, collects data, analyzes trends and prepares reports for assigned quality processes. Has thorough understanding of process criteria and regulations and business impact of decisions and actions, ensures and maintains a state of inspection readiness;
  • Provides quality support for technology transfer and improvement of existing laboratory processes;
  • Provides (standard) definitions, develops and establishes quality and data integrity expectations and ensure compliance to those expectations;
  • Improves the quality of systems processes and standards on the site (leverage on existing and implement new technologies);
  • Translates user requirements into technical specifications and systems following the set DI standards;
  • Makes proposals, writes and assists in CAPA plans and Change Controls, owns, monitors and gives follow up on the implementation and closure of the documentation steps.

Het profiel

Requirements for the function as Lab Services Equipment Life Cycle Specialist:

  • Master’s degree in Life Sciences, analytical chemistry, bio chemistry, or comparable;
  • Project management skills and interpersonal skills, engaged in contact with personnel at all levels within and outside the organization;
  • Written and oral communication skills in English. Dutch is desirable;
  • Planning skills, ability to prioritize multiple commitments;
  • Take the leadership role to coordinate the initiatives and to ensure deliverables are met amongst the different site departments without hierarchical context;
  • Minimal 3 years experience with Project Lead type role;
  • Analytical thinking and (technical) problem solving. Lean/Six Sigma experience is desirable;
  • Experience with equipment buying/validation/write off (will be responsible for full Life Cycle);
  • Pro Active, works independently, takes actions in the absence of specific instruction and can write protocols/reports, business correspondence and procedures; Experience with norms (GMP/ISO).

Het aanbod

This role will be starting as a secondment, but after 6 months a permanent company contract will be offered.

Inlichtingen bij

Interested in this position as Lab Services Equipment Life Cycle Specialist? Contact Leonie Koomen at leonie@heraklespharma.nl or 06-10518323 (evening hours no problem).

Meer informatie
Leonie Koomen 06-10518323
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