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Job Details

CSV Engineer

Company: Optimus Search Limited
Location: Dublin
Reference: BBBH9617
Closing Date: 21 Feb 18
Type: Contract
Salary (£): Negotiable

Job Summary:

Are you a CSV Engineer interested in working for one of Irelands leading names in High-Tech Pharmaceutical Engineering?Are you looking for something new?!Then stop what you are doing and read on!


Are you a CSV Engineer interested in working for one of Irelands leading names in High-Tech Pharmaceutical Engineering?
Are you looking for something new?!
Then stop what you are doing and read on!

Title: CSV Engineer

Rate: Negotiable

Location: Ireland (multiple locations)

Positions Available: 4+

Type: Contract (12 Months Rolling)

A Fantastic new role has just opened up at one of our leading Dublin based clients offering the successful candidate the opportunity to join a hard-working team working on exciting projects in the pharmaceutical sector.

The proposed start date is march - We need YOU

Responsibilities include:

* Use knowledge of FDA cGMP and related regulations and guidelines and specific knowledge of computer validation methodologies and principles to perform CSV on a variety of systems
* Co-ordination of site validation activities as per corporate Software Development Lifecycle and internal Quality Management systems
* Lead the project validation stream for multiple sites
* The candidate should have a good understanding and experience of the following key areas:
* Preparation, Review, Execution and Approval of Validation documents and associated deviations/NCRs for computerised systems
* Analysis of results of testing and determining acceptability of results against predetermined criteria.
* Computer Systems Validation
* Good understanding of Production Applications (e.g. MES, LIMS) with focus on interfaces
* Experience with SAP is a plus
* Experience with validating serialisation/aggregation solutions is an advantage
* Ensuring compliance with current industry regulations and guidelines relating to validation
* Technical writing experience
* Be flexible with regard to project / tasks assignment
* Strong attention to detail and accuracy
* Advise and support project team on computer validation activities
* Strong interpersonal skills to support relationships with a number of stakeholders
* Excellent communicator
* Project planning experience a distinct advantage
* Third level qualification in a relevant discipline
* Experience of QA in a FDA regulated environment is preferred
* At least 5 years of Computer System Validation/pharmaceutical experience
* Past experience writing, reviewing and executing computer validation documentation (Validation Plan, IQ, OQ, PQ, RTM, summary report)
* Experience in risk assessments in relation to validation activities

If you are interested please do not hesitate to email or call me!

+44 20 30969 392v

Apply for this job: CSV Engineer

Contact Information:

Address:  Head Office
171-177 Great Portland Street, London
Tel:  +44 (0) 20 3418 8033
Fax:  +44 (0) 20 7287 4908
Website:  Visit Our Web Site

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