Validation Engineer
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| Job Type | Permanent |
| Area | Dublin, Ireland |
| Sector | EngineeringQuality |
| Start Date | |
| Advertiser | Ashling Guthrie |
| Job Ref | 3026 |
| Job Views | 1277 |
- Description
- Team Horizon is seeking a Validation Engineer for a leading pharmaceutical company based in Dublin. This is a permanent opportunity.
Why you should apply:
You enjoy working on exciting projects and want to work with a global manufacturing site in Dublin.
You want to the opportunity to support a broad portfolio of project activities on site, including new equipment installations, process modifications and prsocess improvements relating to manufacturing, facility & packaging operation
Join a company who offer competitive salaries, benefits and an inclusive environment
What you will be doing:
Supporting on-site based projects for Oral Solids Dose Manufacturing, Facilities and Packaging operations.
Development of the site validation strategy, validation plans, protocols and reports for all equipment and processes, not limited to FATs/SATs, Product validation risk assessments, IOQ's, PQ's etc.
Perform activities in support of the validation program such as risk assessments and review and assessment of development data in line with recognised standards.
Responsible for development, approvals control, execution and closure of the Validation Project plan for all tests and for reviews and update of existing validation system or documents.
Liaise with Manufacturing / Packaging/ Facilities Engineering and end users on the completion of risk assessment for any product line extensions, process improvements or automation projects.
Verifies that validation studies once complete have been adequately recorded, documented and carried out, in accordance with the approved Validation Plan and Protocols.
Provides information on relevant regulations and internal process validation policy with regards to equipment / process validations and qualifications.
Ensures that all deviations to protocols and/or deviations to acceptance criteria are adequately controlled, documented and addressed by the Validation / Engineering Team.
Provides guidance in closing out noncompliance and deviations in relation to Validations.
Provides assistance and ensures the preparation of validation protocols, process design specifications and associated documentation for equipment and systems.
Participates in project teams and assists in determining project schedules and the relevance of appropriate levels of validation
Works with teams and other departments across the plant to ensure project adherence.
Acts as an effective team member in supporting quality disciplines, decisions, and practices.
Applies sound, systematic problem-solving methodologies in identifying, prioritising, communicating, and resolving quality issues.
Control and compliance of Calibration schedules and associated instruments.
Develop and maintain existing and future document control practices.
What you need to apply:
A bachelor’s degree in engineering, Science, or relevant Quality Discipline
Minimum 3-5 years' experience in a Pharmaceutical / Medical Device industries
Ability and proven track record in working and managing multiple departmental teams for operational and capital projects.
Background in OSD Manufacturing & Packaging would be advantageous.
Must possess excellent technical writing ability & strong documentation skills.
Possess strong interpersonal and communication skills.
Must work to the highest engineering standards.
Have strong technical and problem-solving skills Experience in cGMP, general manufacturing, facility & packaging systems.
