CSV Engineer
- Midlands (Ireland)
- Contract
- CAPEX Projects
This vacancy has now expired
Ireland is a hive of activity for the Life Sciences Sector at present with global players setting up new and expanding existing manufacturing facilities all over the Country. An exciting opportunity has arisen to work via Quanta on the client’s side for a global Pharmaceutical organisation on a major expansion project based in the picturesque Munster region of Ireland.
Located just 20 minutes from the nearest international airport, the manufacturing site is workable for those wishing to commute to/from Ireland for a contract position. You will be required on site for 5 days per week Monday – Friday working 45 hours.
Role Summary:
- Prepares/reviews validation documentation related to projects/change controls.
- Manages change controls and other compliance related tasks e.g. non-conformances.
- Participates in the review of current and future CSV procedures and polices Analyses the results of testing and determines the acceptability of results against predetermined criteria.
- Investigates and troubleshoots problems which occur and determines solutions or recommendations for changes and/or improvements.
- Identifies current and anticipated requirements for compliant computerized operations and suggests methods for the identification, implementation, and maintenance of the procedures, actions, and documentation necessary to ensure compliance within the operation.
- Coordinates with other departments or outside contractors/vendors to complete validation tasks.
- Participates in regulatory audits and communicates company’s computer validation policies.
- Assesses company’s computer systems and identifies any potential Part 11 or Annex 11 gaps.
- Manages projects and prepares status reports using Microsoft project and other communication tools.
Requirements:
- Requires BS/BA in Engineering, Chemistry, or Life Sciences with 5+ years of related experience within the fields of Automation and Computer systems and IT Infrastructure Qualification/validation; will substitute relevant experience for education.
- Experience in a GMP environment essential.
- Biologics experience highly desirable.
If this role is of interest to you, please apply now!
#LI-CH3
I have always received a highly professional & personable service from the team at Quanta. They listen carefully to the specific requirements of available roles and work tirelessly to supply a pool of potential candidates and make the hiring and contract renewal process an easy activity to manage.
Global Pharmaceutical firm
We have worked together with Quanta for seven years now and have always received a professional service. Quanta’s speciality certainly lies within their technical sourcing abilities and they have met our demanding requirements time and time again. Coupled with this are the integrity of Quanta’s people and their ability to deliver.
Global Pharmaceutical firm
Once again can I via you recognise the superb support I was given before, during and after this short contract. The support, was as usual professional and every friendly.
QA Specialist
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