PE Global is currently recruiting a Senior Process Validation Engineer for a 12 month contract, with a leading multi-national client in Galway.
This is initially a 12 month contract position.
Duties of the role/Responsibilities
- Provide Quality Engineering support, with a focus on process validation, to product development, technology transfer, improvement projects and/or core teams.
- As part of a cross-functional team, support the execution of process validation activities together with technology transfers from other locations.
- Provide quality focus and technical support for task teams.
- Support the characterization and risk assessment of manufacturing processes and associated equipment.
- Work within project teams to establish process controls that ensure the safety and efficacy of the product.
- Providing on-going communication, information transfer and record keeping in support of department and core-team objectives and metrics.
- Understand product construction, features and uses at a competent level in order to make decisions on product acceptance standards within their scope of responsibility.
- Use and establish analysis techniques and other quality control tools to aid decision – making.
- Functioning effectively as a quality engineering extended product development project team member as part of a wider cross functional team, developing strong partnering relationships with these groups, at both the manufacturing and design sites.
- Participate in and initiate job-related training courses
Education/Experience
- Minimum of a Bachelor’s degree (Level 8 NFQ) in a relevant technical discipline (e.g. Engineering, Science)
- 5-8 years’ experience in a medical devices or related environment with direct experience in a QA environment (GMP regulated).
- A good working knowledge of process validation is required.
- A good working knowledge of equipment validation and software validation would be beneficial.
- High level of interpersonal communication and organizational skills, along with the ability to positively influence project teams.
- Good working knowledge of statistical data analysis and quality improvement tools and techniques preferable.
- Technical writing skills.
- Ability to take initiative, to organize and prioritize own work and proactively contribute to project level strategies and planning.
- Effective time management skills.
- Able to analyze and chart data using MS Excel or Minitab
- Previous Quality Auditor experience is desirable, or certification is an advantage
Interested candidates should submit an updated CV.
Please click the link below to apply, call Chloe on 086 0200448 or alternatively send an up-to-date CV to chloe.slingsby@peglobal.net
***Please note our client cannot assist with any visa sponsorship and candidates must have the correct visa to live and work in Ireland***
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