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Job Details

Validation Engineer

Company: Optimus Search Limited
Location: Cork
Reference: BBBH9876
Closing Date: 13 Mar 18
Type: Contract
Salary (£): Negotiable
Benefits:

Job Summary:

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

Requirements:

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

Title: Validation Engineer

Rate: Negotiable

Location: Cork, Ireland

Positions Available:

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 ASAP- We need YOU

Responsibilities include:

* Implementing the Stryker validation strategy, based on Corporate procedures and regulatory requirements.
* Supporting validation activities by providing guidance and expertise to authors of validation documentation and executors of validation protocols at the local site.
* Reviewing and approving of validation documentation to ensure compliance with regulations and validation best practices.
* Will work within the QA Shared Services Validation Team, responsible for validation related activities, including, but not limited to the following:

* Having knowledge of and ability to provide Interpretation and Guidance on Regulations, Corporate, Divisional and Site Local procedures as they relate to validation activities.
* Participating within Corporate Validation Team to develop and revise Validation Procedures and Templates to ensure that Current Regulatory Compliance and Company Objectives are maintained.
* Participating on both Corporate and Local Validation Teams to discuss / give feedback and approve revisions to Validation Procedures.
* Representing validation at both internal and external audits.
* Ensuring that Validation Practitioners receive training/coaching to allow them to effectively support and/or perform validations for current and anticipated projects.
* Ensuring that appropriate Systems are in place to evaluate changes to Validated/Qualified Systems to ensure their continued validated/qualified state.
* Ensuring that appropriate Site Validation Listing is established and controlled as per Current Regulatory and Company Requirements.
* Reviewing and approving of Validation/Qualification Documentation.
* Working with Validation Consultants/Contractors as required ensuring that Validations are completed as per corporate and divisional procedures.
* Being the site responsible for at least 1 validation specialty and be the primary support for that specialty and site.

Requirements

* Have a good understanding of engineering and machine tool fundamentals.

* Must be proficient with Microsoft Word, Microsoft Excel and PowerPoint packages.
* Self-starter with demonstrated efficient work methods, analytical & problem solving skills and ability to handle multiple tasks in a fast paced environment.
* Knowledge of Computer System Validation including GAMP 5 and 21 CFR part 11 requirements desirable.
* Working knowledge/experience of Risk Based Techniques i.e. FMEAs, FTAs etc.
* Have a good understanding of statistical techniques, in particular statistical sampling plans, Process Capability, Gauge R&Rs.
* Strong knowledge of Quality Concepts (e.g. CAPA, Audits, Statistics).
* Lean Six Sigma training a distinct advantage.

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

Shubert@optimussearch.com

+44 20 30969 392

Apply for this job: Validation Engineer

Contact Information:

Address:  Head Office
171-177 Great Portland Street, London
W1W 5PG
England
Tel:  +44 (0) 20 3418 8033
Fax:  +44 (0) 20 7287 4908
Website:  Visit Our Web Site

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