Orion Group Life Sciences are currently recruiting Project Engineer on behalf of our Multinational Medical Device client based in Ringaskiddy, Cork on an initial 12-month contract.
The role involves utilising project management best practices for the effective and efficient development and/or transfer of products/processes into commercial operations. The successful candidate will also utilise Engineering principles and problem-solving skills to improve and maintain products/processes that are aligned with the overall Quality and Business vision. He/she will be tasked at the design, procurement, installation, validation of assets that will be involved in the manufacturing of knee/hip construct.
- Team member representing the Engineering function supporting projects with a focus on capacity expansion, install, validation, of assets used in the manufacturing processes.
- Prepare several documents as part of the IQ, OQ, PQ processes.
- Support colleagues to complete several tasks
- Responsible for ensuring design of machine is aligned with operation's needs, quality, EHS, validation, quality automation, maintenance requirements.
- Validate the machine as per the specifications, procedures, regulations
- Determine operational & process inputs and outputs ranges of machine prior to commencing validation
- Responsible for conducting (where appropriate) Installation, Operating and Performance Qualification (IQ, OQ, PQ)s of assets and associated machines.
- Develop pFMEA documentation to support processes as part of Validation process
- Partner with Quality, Operations, CSV, and other cross functional partners to ensure the correct application of design controls, risk management and the investigation/correction of design failures/challenges.
- Communicate effectively with project manager and other managers, global functions, and internal team on status of project(s) tasks, issues, and requirements.
- Provide timely and accurate reporting and management of escalations as appropriate on project activities.
- Ensure all activities comply with GMP, ISO and quality system requirements. Ensure that all health, safety, and environmental requirements are fulfilled.
- Work with vendor to ensure design specification documents meet site requirements.
- Ensure asset meets requirement specifications as per agreed User Requirement Specification (URS).
- Complete testing with vendor to ensure parts are processed correctly, efficiently and meet quality requirements.
- Develop training documentation and supply training to appropriate function for general asset operation, recovery methods and preventative maintenance.
Essential Education and Experience
- BSc in Engineering or Science with 2 years' experience in a medium to high volume manufacturing environment.
- 1 year in a similar capacity in a regulated industry (i.e., FDA/ISO).
Desirable Education and Experience
- Experience working in both an FDA and European regulatory environment is preferred with an in-depth knowledge of 21 CFR 820, CFR 11 and European regulations associated with the medical device industry.
- A thorough understanding of GMP/ISO and validation regulations.
- Technical training (Six Sigma Black Belt / Statistical Engineering) and experience using Statistics, Lean and Six Sigma Methodologies is preferred including Measurement System Analysis, SPC, DOEs, Reliability, etc.
- Problem solving engineering expertise (Six Sigma, SE or A3).
- Understanding of the Mechanical Engineering process and Process Validation expertise is preferred.
- Strong verbal and written communication skills.
- Knowledge of Cognex vision system for support of vision job files using insight explorer
- Knowledge of dataman scanners.
- Training in robotic loading systems, preferably Fanuc and ABB.
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.