CSV Engineer - Netherlands - Dublin

Job Title: CSV Engineer - Netherlands
Company: Anonymous
Country: Ireland
Provincia: Dublin
ID: 174000599
Publication Date: 20/03/2019

Job Description: CSV Engineer - Netherlands

Company: Anonymous

CSV Engineer- Holland
6 Month+ Contract
ERM Engineering + Construction a specialist provider of advanced engineering, design, consulting, construction, CQV, project controls, support services across the Biopharma, Semiconductor, AMT, Medical Device and Data Centre Construction sectors in Ireland and Internationally
The Computer Systems Validation Engineer will be a key supporting contract member of the quality team within a global pharmaceutical leader. The successful candidate will use policies and procedures to validate/qualify computer systems including automation systems, IS applications and enterprise systems.
Experience Required:
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Process engineering and/or validation experience in a sterile manufacturing environment and have a proven track record in leading a technical team of engineers/scientists through sustaining operations and technical projects
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Considerable experience in a comparable role
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Experience operating as a senior professional
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Experience in leading through change would be an advantage
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Knowledge of regulatory/code requirements to Irish, European and International Codes, Standards and Practices
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Knowledge and experience of Sterile filling processes and equipment - aseptic processing
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Experience of executing and/or managing through equipment and process design and validation in a sterile environment
Key Duties:
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Generation, execution, review and approval of IOQ protocols, associated validation documents and CSV assessments
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Prepare/review validation documentation related to projects/change controls
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Manage change controls and other compliance related tasks
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Participate in the review of current and future CSV procedures and policies
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Investigate and troubleshoot problems which occur
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Coordinate with other departments or outside contractors to complete validation task
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Manage projects and prepare status reports
Qualifications and Experience:
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Third level degree in Engineering, Chemistry or Life Sciences
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5+ Years related experience
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Experience in a GMP environment is essential
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Biologics experience is desirable
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Must have good interpersonal skills. Position will require a good deal of interdepartmental interaction and coordination.
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Must possess a thorough understanding of GxPs, in addition to FDA and International requirements for computer validation and Part 11 / Annex 11 requirements.
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Must possess a thorough understanding of current industry guidance, including GAMP 5
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Must have direct experience with CSV and determining computer validation approach.
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Must have ability to comprehend technical information related to computer software, computer and network hardware, and the associated regulatory requirements relating to them.
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Experience/Knowledge in qualifying DeltaV, OSI PI, Serialisation changes.
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Experience with HP ALM or equivalent software testing/requirements tools
To discuss these any many and more project opportunities please send your Word Format CV to Philip Cahill, Talent Acquisition Manager, ERM Engineering + Construction.
Cell: - (0) (phone number removed), Phone: - (1) (Apply online only)

Work Day: Full Time
Employment type: Permanent Job
Salary: Negotiable

Age requirements:
Minimal experience: No experience


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CSV Engineer - Netherlands
Provincia: Dublin