LSC have a great contract opportunity for an AIT Laboratory Project Engineer to join a Dublin based Biopharmaceutical company dedicated to discovering, developing, and delivering innovative medicines that can help patients overcome serious diseases and improve their quality of life.
If you have at least 4 years previous industrial experience in a similar role and are ready for your next challenge, this could be the perfect project for you!
ABOUT THE PROJECT - KEY RESPONSIBILITIES:
This contract position of an AIT Laboratory systems engineer is required to support, and reports to, the Laboratory Leads to meet the introduction of new, Instrument Systems in the Laboratories.
They will work closely with Quality Assurance, Quality Control, Computer System Validation, and IT functions to ensure the ingoing operation and compliance of the laboratories systems for the site.
- Ensure that all work on Lab IT and Benchtop Analytical equipment is carried out in a compliant manner, meets 21 CFR Part 11, EU Annexe 11, cGLP/GMP's, and Corporate & local site compliance requirements.
- Support the introduction of new instrument systems.
- Work with all departments, QA, QC, CSV, NQC Engineering, and with contract vendors.
- Working with external laboratory suppliers to assist, configure and commission benchtop equipment. Take ownership of equipment in receiving deliveries and keeping track from delivery to commissioning.
- Technical design engineer for the Lab IT/GMP/Regulatory systems including integration to other systems such as Chromatography and Benchtop analytical equipment. Work under the direction of the IT Applications manager and with other team members from the corporate laboratory systems team to deliver systems and interfaces.
ABOUT YOU - ARE YOUR SKILLS A MATCH?
- * Degree in Engineering, Information Systems, Computer Science or Life Sciences.
* At least 4 years' experience of working in a pharmaceutical laboratory environment, with IT experience of laboratory instrument systems.
* Experience with Solovpe, FIT, Osm, Raman systems.
* Good working understanding of Windows file permissions, networking, Active Directory, Group Policies.
* Experience of working in GMP Quality Management Systems in laboratory or manufacturing environment.
* Ability to keep work pace and meet deadlines. Good organising and planning skills.
* Strong leadership, communication skills, critical thinking, and customer management skills.
* Proven success working well in a team environment with flexibility to react to changing business needs.
* Ability to anticipate, evaluate and resolve multiple, simultaneous operational issues.
* Ability to work independently and remotely with minimum direct supervision.
* Thorough knowledge of Pharmaceutical Industry Regulations (cGMP/cGLP, OSHA, EPA/EQB), 21 CFR 11 and EU Annex 11 as they relate to Lab IT systems.
Apply via this advert or contact Paul O'Driscoll on 021 4777 329 if you have any more questions about this opportunity!
