Validation Engineer - Sterile Fill/finish Pharma - Sicily

Sicilia  ‐ Onsite
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Description

A fantastic contract opportunity has arisen for an experienced VALIDATION ENGINEER to work at a
world leading Pharmaceutical plant on a large remediation project, to bring the project back on track.

Working within a STERILE FILL/FINISH manufacturing environment, we are looking for a number of VALIDATION ENGINEERS to work on the remediation programme and carry out the validation execution to equiment within a sterile/fill finish equpment such as: Autoclaves, Depyrogenation, Capping, VHP's, lyophisers etc

Responsibilities:

Carry out the validation activities within an aseptic/sterile environment, taking responsibility for creating specific equipment validation strategies. Undertake validation exercises on Autoclaves, Lyophilisation units, fillers, cappers and solution preparation within a sterile/aseptic pharmaceutical environment. Review/produce supporting validation documentation, as required, as part of a validation exercise. (IQ/OQ/PQ) Write and review validation protocols and reports for new and existing equipment.

Requirements:
  • Degree qualified in Engineering based subject or related experience in a Validation/Qualification role.
  • Experience within Sterile/Aseptic pharmaceutical Manufacturing environments with an understanding of equipment to include Autoclaves, Lyophilisation units, cappers, fillers, solution preparation.
  • Solid experience of project life cycle validation activities to include the qualification of equipment in conjunction with Project engineering/CAPEX teams.
  • Demonstrable experience in drafting, executing and reporting of validation documentation ie. IQ, OQ, PQ protocols.
  • Experience of working alongside regulatory auditors, liaising with FDA and/or MHRA investigators during audits. Fill/Finish.
Beautiful location! 6 month contract with a likely extension. All inclusive hourly rate required Euros

Desired Skills and Experience
  • Validation execution
  • Creation of documentation IQ OQ PQ
  • Equipment experience - Autoclaves, CAPPING, depyrogenation, VHP's, lyophilisation
  • Sterile OR Aseptic experience
Start date
ASAP
Duration
6 months +
(extension possible)
From
Quanta Consultancy Services
Published at
29.02.2016
Project ID:
1080743
Contract type
Freelance
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