Contact: Karl Lippett
Telephone: 086 1070950
Validation Engineer - Contract
Our client, a medical device company in Cork are currently looking to recruit a Validation Engineer for their site on a contract basis.
The QA Validation Engineer, plays a key role in the planning and execution of validation activities related to new product introductions, product transfers, new technologies and process changes. Provides support for the validation activities associated with equipment & processes ensuring that all compliance issues and requirements of Company validation policies and procedures are addressed. Provides support for the periodic validation reviews and administration of the site validation master plan and registry.
- Prepare periodic validation review documentation for approval by the business units.
- Maintain site validation registry.
- Ensure validation activities completed are in compliance with US and EU relations, GBSC procedures and EHS requirements.
- Review and approve documents prepared by project teams, other departments and contractor organizations (e.g. protocols, reports, change controls)
- Assist in development of validation strategy and validation plan for equipment and process validations.
- Assist in the development of sampling plans, test plans and data analysis related to process validation.
- Assist in resolution of deviations/ exceptions during qualification activities
- Assist with change control activities in accordance with site procedures
- Attend identified training, required to fulfil the role of QA Validation Engineer
- Support the QA Validation team leader in driving improvements within the Validation and Change Control processes to streamline the validation activities associated with Process Changes, Product Transfers and/or New Product Introductions.
- Support the QA Validation team in developing and standardizing guidance for introduction and qualification of processes and equipment to the site.
- Participate in cross-functional teams as required.
- Process/Quality input for validation processes and new product introduction.
- Adherence to site validation procedures and regulatory requirements.
Key Competencies Required:
- Excellent Communication Skills
- Pro-active approach to work
- Team Player
- Highly computer literate
- High attention to detail
- High work standards
- Planner and organizer
- Active listener
- Hons. Degree Quality/ Manufacturing / Engineering / Science
- Minimum of 2yrs experience in Quality Assurance/Engineering
- Working knowledge of Quality systems (FDA/ISO) within a regulated environment
- Ability to analyse Capability data using MINITAB
- Ability to interpret Engineering drawings/specifications
- Familiarity in areas of various inspection techniques
- Excellent interpersonal & communication skills
- Process validation experience
- Equipment qualification and test method validation experience
- In depth knowledge of 21 CFR 820, 21 CFR 11, ISO 13485 and European regulations associated with the medical device industry
- High understanding of GMP, Compliance, Validation practices including the system development life cycle and regulatory expectations
For further information on this Validation Engineer role in Cork please contact Karl Lippett on 086 1070950 / firstname.lastname@example.org
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