GerTEK is an engineering consultancy company specialising in project management, talent solutions and commissioning qualification and validation services (CQV) to the life sciences and technology sectors. We partner with many of the world’s largest life science & technology companies who entrust in us to deliver their most strategic and important projects with our technically strong personnel ensuring all important activities meet both current requirements and client’s needs.
We are hiring for Project Engineers for the Sligo & Galway regions.
- Supports the introduction of new equipment from through qualification. Working with the validation team on the process qualifications and new equipment introduction controls.
- Work on corrective actions on processes and manage through design and change management processes.
- Implements the design of new equipment or process improvements – Implements the design for equipment or process changes and ensures designs meet established requirements through equipment and process qualification.
- Maintains adherence to the Quality System -Implements and maintains the effectiveness of the quality system. Follows functional area policies and procedures.
- Utilizes appropriate experimental, statistical and engineering tools.
- Initiates and completes technical activities leading to new or improved products or process, for current programmes, next generation programmes and to meet strategic goals and objectives of the company.
- Prepares reports, publishes, and makes presentations to communicate findings.
- Analyses and solves problems from basic engineering principles, theories and concepts through to a wide range of complex and advanced problems which require novel and new innovative approaches or a major breakthrough in technology.
- Work with stakeholders in Engineering, quality and Operations at sites /Division Engineering to clearly identify requirements/ needs and be able to develop solutions for same.
- Work with external equipment vendors in the selection, design & development of new (or upgrades to existing) equipment.
- Work with commodity support team on design improvements.
- Contribute to the design of technical specifications, SOPs, protocols and validation documentation (FAT/SAT/IQ/OQ/PQ) to meet quality and regulatory requirements.
Education & Key Requirements
- Degree educated in Engineering or related discipline
- 3-5 years plus professional experience
- Promote a continuous improvement culture
- Strong understanding of the principles of current Good Manufacturing Practices (cGMP)
- Troubleshooting skills and excellent attention to detail