The role:
PE Global is currently recruiting for a Validation Engineer on behalf of a leading medical device company based in Cork. This is an initial 6-12 month contract role.
Responsibilities:
- Own and support validation activities in a Medical Device regulated environment.
- Responsible for assigned Process / Equipment / Facility / Utility / Software and Computer System Validation as assigned.
- Generate Validation Plans, Protocols and Reports in support of assigned validation activity.
- Resolution of Problems encountered during validation.
- Ensure Consistency in validation/qualification approach across systems and projects.
- Provide guidance and direction in the preparation and execution of validation activities.
- Be fully conversant and up to date with GMP requirements for site-wide regulatory body compliance.
- Maintain Validation system including conducting Periodic Reviews.
- Participate in change control processes for manufacturing Process / Equipment / Facility / Utility / Software and Computer System modifications.
- Assure ongoing compliance with quality and industry regulatory requirements.
Education and Experience:
- Level 8 Degree Preferably in a Science, Electronics, Mechanical or Industrial Engineering.
- Experience in working within a Medical Device Manufacturing / Pharmaceutical Environment.
- 3-5 years experience in a validation engineering role
- Minimum of 1 year Quality Assurance / Regulatory affairs experience.
- Experience of supporting or completing Process / Equipment / Facility / Utility / Software / Computer System Validation.
- Experience in statistical Analysis / DOE and DMAIC methods.
- Experience in using the GAMP 5 approach is preferable but not essential.
Interested candidates should submit an updated CV.
Please click the link below to apply, call Kellie on 0214297900 or alternatively send an up to date CV to kellie.hackett@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***
