Our client, a medical device company in Cork are currently looking to recruit a Validation Engineer for their site on a contract basis.
The purpose of this role is to develop and conduct appropriate procedures regarding the Qualification and Validation of company equipment, processes, and systems.
Management, Engineering, R & D Personnel, IM Personnel, outside Suppliers, other sites
- Responsible for ensuring conformance with current equipment, process, and systems validation regulations
- Responsible for determining the implications of validations upon; Product Quality, Patient Safety, and Data Integrity.
- Responsible for completing gauge R&R qualifications.
- Participate in Worldwide equipment, process, and software development
- Responsible for determining and implementing control measures to reduce the occurrence and possible impact of failures.
- Responsible for determining process inputs and factors for variation where process capability is required
- Responsible for calculating process capability
- Maintain complete and accurate documentary evidence concerning Qualification and Validation exercises.
- Responsible for communicating and obtaining input/acceptance of stated exercises by relevant departmental personnel.
- Responsible for conducting (where appropriate) Installation, Operating and Performance Qualification (IQ, OQ, PQ) s.
- Responsible for validation activities for NPI’s / product transfers.
- Responsible for Quality Engineering responsibilities of NPI’s / product transfers
- Responsible for process and equipment risk management pFMEA / RA
- Responsible for implementing/validating new technologies.
- Contribute towards company procedures regarding validations.
- Responsible for conducting periodic review activities concerning the above.
- Ensure HSE is included on all Quality change order procedure.
- All employees are responsible for minimizing both the Environmental and Health & Safety effects of the work that they perform.
Key Competencies Required:
- Demonstrate standards of leadership – Managing complexity
- Interdependent Partnership
- Credo Values
- Customer / Market Place Focus
- Excellent Communication Skills
- Pro-active approach to work
- Team Player
- Influencing skills
- High level of validation knowledge
- Highly computer literate
- High level of GMP knowledge
- Excellent project management skills
- High attention to detail
- High work standards
- High level of numeracy
- Excellent planning and organisation skills
- Customer focused
Qualifications & Experience
- Degree level qualification in Engineering/Electronics or Equivalent.
- Minimum 5 years post qualification experience as a Validation Engineer within a medical device, pharmaceutical, or similar regulated industry.
- Experience in aspects of QA, validation and ISO 13485.
- GD&T Certification
- Six Sigma Black Belt Certified
- Statistical Engineering Qualification
All applicants must have a working visa for Ireland for this contract role
For further information on this Validation Engineer role in Galway please contact Caroline Kingston on 086 8395531 / email@example.com
Check out all our open jobs on our HERO Recruitment website – www.hero.ie
Please Note: HERO Recruitment will not forward your details to any company without your prior approval