Job Title:  Project Commissioning Engineer

Position Summary

Reporting to the Project Commissioning Manager, the Commissioning Engineer is responsible for supporting

projects in Europe, Africa and Asia including qualification and validation activities for new installations and/or

upgrades to existing facilities to ensure they meet business and regulatory requirements.

Duties

- To supervise and execute (where appropriate) the validation of automated machinery and software systems remotely and/or on-site. This will involve managing/supervising, liaising, and overseeing elements of the process with stakeholders both internally and externally to STERIS as appropriate to ensure activities meet deadlines. (20%)

- In conjunction with both internal and external stakeholders, ensure User Requirements Specification, Functional & Design Specifications, Risk Assessments and other GAMP documentation are developed and approved to meet STERIS requirements. (20%)

- 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. (15%)

- 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. (15%)

Duties - cont'd

- To support the STERIS business in validation activities within the region outside of regular project team role. (10%)

- Responsibility in conjunction with the Quality team for supervision of qualification compliance of existing and new systems to STERIS and regulatory validation requirements. (10%)

- In conjunction with the project and extended STERIS teams work to identify and/or liaise with suppliers to ensure that they are competent and deliver on contractual obligations specific to validation and commissioning requirements. (5%)

- Provide updates and feedback to line manager and/or project teams on progress of on-site activities. (5%)

Education Degree

Required Experience

1. Working knowledge of plant or related software upgrades and involved in:

a. Gathering and documenting requirements from stakeholders

b. Working with suppliers and internal teams through documentation and

installation/project steps

c. Knowledgeable in the process of validation and testing

d. Good understanding of operational/business requirements and impacts

e. Trained in and implemented projects using Validation, GAMP 5, 21 CFR

Part 11 and Annex 11 or equivalent industry standards or approaches

2. Writing and reviewing validation documentation.

3. Coordinate activities between internal and external teams.

4. Depending on project timeline and/or location, occasional extended hours or work

weeks may be necessary; but is usually limited to key commissioning activities

and/or periods. Commissioning periods vary but may last approx. 3-6 weeks per

project.

5. 2-4 Years of work experience involved in Project Management will be considered in Lieu of Bachelors Degree