Job Title:  Project Commissioning Engineer

Position Summary

Reporting to the EO Plant Manager, the Commissioning Engineer is responsible for supporting Tullamore EO and broader campus projects including the validation activities of existing systems, new installations, and upgrades to ensure they meet regulatory and STERIS requirements.

Duties

• In conjunction with the project team work to identify and liaise with suppliers to ensure that they are competent and deliver on contractual obligations specific to validation and commissioning requirements in conjunction with the project and extended STERIS teams.
• In conjunction with both internal and external stakeholders, ensure User Requirements Specification (URS), Functional & Design Specifications, Risk Assessments and other GAMP documentation are developed and approved to meet STERIS requirements.
• To create validation test scripts and protocols as required. If such scripts are created by suppliers, ensure that they are adequate as per STERIS procedures and GAMP requirements prior to approval.
• To support and advise project teams and other STERIS employees and facilitate the validation of new equipment, systems and processes as per STERIS procedures and GAMP requirements.
• To supervise and execute (where appropriate) the validation of automated software systems. This will involve managing and overseeing elements of the process with stakeholders both internally and externally to STERIS as appropriate to ensure activities meet deadlines.
• Responsibility in conjunction with the Quality team for supervision of qualification compliance of existing and new systems to STERIS and regulatory validation requirements.
• To support the STERIS business in validation requirements within the Ireland region as required.    

Specific work requirements

1. Have worked on plant or related software upgrades and involved in:
   1. Gathering and documenting requirements from stakeholders
   2. Working with suppliers and internal teams through documentation and installation steps
   3. Knowledgeable in the process of validation and testing
   4. Good understanding of operational requirements and impacts
   5. Trained in and implemented projects using Validation, GAMP 5, 21 CFR Part 11 and Annex 11 or equivalent industry standards
2. Writing and reviewing validation documentation.
3. Coordinate activities between internal and external teams.

Specific Skills and/or Business Competencies

• Ability to communicate well with stakeholders at all levels both internal and external to the business.
• Ability to explain technical industry specific requirements for wider audiences (for new suppliers or non-technical colleagues).
• The ability to work with and lead teams.
• Attention to detail.
• Works well under pressure.
• Commercial awareness.
• Competent in use of MS Word, PowerPoint, Excel, and experience of using MS Project

Interpersonal skills. Incumbent must have excellent communication skills so that he/she can work with managers from other departments, as well as with the company’s senior-level management.

Competency

•            Teamwork

•            Customer focused

•            Delivers and Executes Results

•            Communication

•            Job Knowledge/Business Acumen

•            Initiative/Leadership

•            Professional/Talent Development

Problem-solving skills. Commissioning Engineer must be able to identify problems immediately and tackle them.

Time-management skills. To meet processing deadlines, Commissioning Engineer must carefully handle their employees’ time as well as their own.

Education Degree

Required Experience