Contract (Full time)
Orion Group are looking for a Validation Engineer for our multinational medical devices client based in the Cork area on an initial 12-month contract with the potential to extend.
- The purpose of this role is to develop and conduct appropriate procedures regarding the Qualification and Validation of company equipment, processes, and systems.
Main Responsibilities of the role
- 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
Desired Experience and Background of the successful candidate
Degree level qualification in Engineering 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.
Six Sigma Black Belt Certified
Statistical Engineering Qualification
Demonstrate standards of leadership - Managing complexity Interdependent Partnership
Excellent Communication Skills
Pro-active approach to work
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
Our role in supporting diversity and inclusion
As an international workforce business, we are committed to sourcing personnel that reflects the diversity and values of our client base but also that of Orion Group. We welcome the wide range of experiences and viewpoints that potential workers bring to our business and our clients, including those based on nationality, gender, culture, educational and professional backgrounds, race, ethnicity, sexual orientation, gender identity and expression, disability, and age differences, job classification and religion. In our inclusive workplace, regardless of your employment status as staff or contract, everyone is assured the right of equitable, fair and respectful treatment.
Posted 75 days ago