LABORATORY PROJECT SUPPORT SPECIALIST

Job Purpose:

  • To drive all support projects in the Analytical Laboratory with the goal of streamlining all laboratory activities, processes, equipment, electronic systems and documentation as identified.
  • To facilitate the roll out of all Analytical Laboratories improvement (LI) projects that will create value in other EirGen Pharma Campus Laboratories as appropriate.
  • To actively participate in campus continuous improvement projects on behalf of the R&D Analytical department.

Responsibilities:

  1. To critique and report on all existing laboratory activities, processes, equipment, electronic systems and documentation and to identify Laboratory support projects in conjunction with the Analytical Services Manager.
  2. To determine tasks and resources in conjunction with the Analytical Services Manager required in order to deliver each Laboratory support project by breaking them down into tasks; identify equipment, materials and people needed.
  3. To actively plan & lead all Laboratory Improvement projects from conception to implementation and then on to further improvement in conjunction with the Analytical Services Manager and relevant stakeholders.
  4. To actively participate as Project Support Specialist in any new Laboratory Support Project for eg streamlining of laboratory activities, introduction of new software, procedures or processes.
  5. To actively participate in campus continuous improvement projects on behalf of the R&D Analytical department.
  6. To attend project review meetings and to provide project plan information to clarify situations before deciding a way forward taking all the facts on board.
  7. To gain agreement from partners to support or take action which supports or builds the partnership; using sound rationale to explain value of actions.
  8. To proactively build effective working relationships with core team and functional members across campus. To facilitate the roll out of all R&D Analytical Laboratory improvement (LI) projects across EirGen Pharma Campus Laboratories as appropriate.
  9. To actively support the Empower Specialist in implementing all new Empower Software projects for example when implementing new custom fields or new testing /validation environments.
  10. To provide feedback on the status of all projects to ensure they remain visible to all key stakeholders and customers.
  11. To periodically audit all Laboratory 5s and Lean processes in order to ensure that all gains are sustained.
  12. To ensure that all work carried out is in compliance with the required standards conforming to company, cGxP, SOP’s, regulatory regulations and guidelines, safety and environmental guidelines.
  13. Health and Safety:
  14. To ensure requirements of EirGen’s Safety Statement are implemented.
  15. To continuously promote a positive safety culture by leading by example
  16. To implement safety requirements as per site documentation including SOP’s, Safety Statement and COP’s.
  17. To report/ action any defects/hazards.

The ideal candidate will have:

  1. A relevant qualification in Analytical Chemistry, Pharmaceutical science or related discipline.
  2. At least five years’ experience working in a senior role within a regulated Laboratory environment is preferable.
  3. In depth knowledge of the Empower software system is required. Qualification as an Empower super user or Empower administrator is an advantage.
  4. In depth knowledge of laboratory software systems and their design is advantageous, including FTIR, UV, TOC.
  5. Experience with Change Controls, deviations and root cause analysis is an advantage
  6. Proven track record of leading projects from concept to closure.
  7. Proven track record of working in cross functional teams in order to deliver projects on time.
  8. Proven ability to think of unique solutions to challenges and look at things with a fresh eye.
  9. Demonstrated ability to achieve buy in from stakeholders to ensure project goals are achieved.

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