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Principal Engineer/Lead

Employer
i-Pharm Consulting
Location
Dublin, Dublin North, Republic of Ireland
Salary
Negotiable
Start date
10 Mar 2023
Closing date
24 Mar 2023

View more

Discipline
Quality, QA / QC
Hours
Full Time
Contract Type
Permanent
Experience Level
Management

Job Details

A Global Pharmaceutical company working on revolutionary biologics projects transforming the discovery, development, and manufacturing of biologics.

This role will be all encompassing, involving quick decision making, collaborative working, people management and having the ability to adapt and excel within a dynamic, fast paced working environment.

The core responsibilities are:

  • Leading/Managing a team of QC Lab Systems IT engineers for Information Systems supporting Quality and Laboratory information equipment.
  • Owning the IS aspects of Lab equipment which includes analytical equipment platform architecture, system ownership and lifecycle management.
  • Meeting 21 CFR 11 and EU Annex 11 compliance requirements for all Lab IT systems and Benchtop Analytical Equipment.
  • Provide effective communication and play a leading role in project management interaction with internal and external clients such as Quality Assurance, Regulatory Affairs, and QC analytical personnel.
  • Lead and support system improvements, development of detailed specification and standard operating procedures.
  • Ensure that all associated protocols/reports are completed, reviewed and approved within agreed timelines in order to secure reliable, consistent & compliant operation of all Lab Equipment\Instruments to meet the GMP and business requirements of the labs.
  • Lead technical root cause analysis, incident investigations and troubleshooting issues related to the Quality and Laboratory information systems.
  • Experience in change control, non-conformance, corrective and preventative actions, and validation practices.
  • Support new technology introductions by performing IS assessments and implementing IS system configuration changes.
  • Participate in Computer Software Validations.
  • Solving complex problems, project management, lifecycle management and operational excellence.

The ideal person profile must have:

  • Must have Quality or Laboratory information systems (IS) in the biotechnology or pharmaceutical industry.
  • Experience in any of the following: Chromatography (Empower - Waters), Lab Data Archival (Nugenesis - Waters), Electronic Methods Execution/Electronic Lab Notebook (SmartLab - Biovia) LIMS (Sample Manager - ThermoFisher), Environmental Monitoring (MODA).
  • Leadership skills.
  • Experience in a QC/GMP experience is required.

If you have the above skillset, please apply and I will give you a call within 24 hours discussing the role and what the overall position includes.

Company

i-Pharm Consulting provides Talent Solutions for the global Life Sciences sector.

We are an award-winning international life sciences recruitment company with offices in London, Munich, Frankfurt, Sydney, New York, Charlotte, and Los Angeles. In a highly competitive marketplace, we connect top talent with the very best opportunities.

Since 2008, i-Pharm’s independent, expert, and ethical approach to procuring talent has helped power the pioneering progress made by Pharmaceutical, Biotech and MedTech companies around the world. 

With offices across 3 continents, we have teams servicing the major global life science hubs. We combine local knowledge, with a global network of contacts that allows us to bring together talent and opportunity when it matters most.

For candidates, we become “career partners”. We know them as people, not CVs, learning about their aims, motivations and personal situation. We build open dialogue, provide honest advice and offer ongoing support, whether or not we’re currently working with them. ​

As a result, we have supported many specialists in this focused field throughout their careers, helping them plan their path through life sciences by identifying the right roles for them, not just any roles to suit us.

We change the lives and trajectory of our candidates' careers by offering incredible opportunities with the best clients in the sector.

 

Company info
Website
Telephone
+44 (0) 20 3189 2299
Location
52 Bedford Row
London
England
WC1R 4LR
United Kingdom

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