- Provide support to design teams.
- Coordinate of vendor/contractor actions.
- Review/ prep. of commissioning/ verification docs for equipment.
- Plan/ coordinate FAT.
Execute commissioning/ OV
- Coordinate punchlist mgt/ turnover.
- Provide input to project staff of status.
We are looking for Process Engineers in Ireland and Mainland Europe for our growing practice.
Commissioning Agents, Inc is an Employee Owned Company (ESOP). We take pride in the services that we offer to our clients, and have established a reputation of excellence within our industry.
From day one, you will be a valued member of our team, working with our clients in a challenging and empowering environment.
Our compensation package rewards you for the skills and value you contribute to the success of our organization. As a global service provider, we offer the opportunity to travel and work with various cultures. We also value a work/life balance, and as life takes its course, we can work with you to find a desirable city or region that best fits your personal goals.
You supply the drive and creativity. We will supply the opportunity. At Commissioning Agents, Inc, you truly can “create your own future.”
Duties & Responsibilities:
- Responsible for providing technical support and input to the design teams
- Co-ordindation of vendor and contractor activities
- Review and preparation of commissioning and verification documents for the main process equipment
- Planning and co-ordination of FAT
- Executionof commisisoning and OV
- Planning and Cordination of punchlist managment and turnover
- Investigate out-of-specification occurrences and make recommendations for corrective action.
- Provide timely input to supervisors, project managers, and pharmaceutical development personnel as to project status, process development, and technology transfer activities and requirements.
- Minimum of a Bachelor's degree (or equivalent)in Engineering or Science and a minimum of 5 years of manufacturing, or project related experience. However, a combination of experience and/or education will be taken into consideration.
- Must possess knowledge of cGMPs and SOPs applicable to position. Knowledge of 21CFR Part 210 and 211.
- Understanding and knowledge of the ASTM E25--07 science and risk based verification approach to Qualification is an advantage.
- Knowledge and understanding of manufacturing Biotechnplpogy Operations, equipment and facilities.
- Basic knowledge of computer programs (Microsoft Office, including Word, Excel, Project).
- A background knowledge in pharmaceutical science or engineering is required.
- Aseptic process experience is a plus.
- Must possess good interpersonal skills, effective verbal and written communication skills.
- Must possess good problem solving skills.
- Working knowledge of root cause analysis and investigation process.