ECO Validatie Project Engineer

工作内容

DPS

DPS is a leading Project Management and Engineering Company serving industries around the world for over 40 years. Specialising in the life sciences, medical technologies, oil and gas, energy and advanced technologies sectors, the Group provides consultancy and process engineering expertise to leading clients globally via their four operating business units.

One of these business units is DPS Contract Services. We provide contingent contract and temporary labour to the existing customer base within the engineering field for clients in the scientific and technology sectors throughout Europe via their network of offices located in Ireland, UK, Belgium and Holland. We also provide engineering staff to the various DPS divisions on a contract basis.

Role

The project as Project Engineer ECO Validation is situated within the Micro Operations department of the Quality Operations (QO) department of the Puurs production site.

The ECO Validation team is responsible for the validation of cleanrooms (grade B, C, D) and clean equipment (grade A).

• The validation program consists of physical and microbiological tests. The ECO Validation Project Engineer Consultant is responsible for independently carrying out, following up, and reporting on the ECO validation studies. This to demonstrate that the it complies with the applicable cGMP and PQS guidelines for aseptic pharmaceutical production. Coordinate the validation projects within the ECO team as well as in the project team consisting of different departments such as e.g. Engineering, Production, etc.
• Draft the validation protocol and determine the validation approach in accordance with cGMP, internal guidelines and legal standards
• Plan, coordinate and follow up the practical execution of the validation studies
• Review the processing and evaluation of test results
• Coordinates or carries out its own (M1) investigation in case of deviating and/or non-compliant results
• Completes the final validation report within the predetermined due date
• Draws up a program for routine ECO testing
• Executes improvement projects to support ECO activities, both for the Environmental Monitoring department and for the various production departments
• Ensures appropriate training and development of the ECO Sampling & Trending team in relation to the implemented projects to achieve a smooth handover
• Participates in site and corporate teams and audits related to your expert area

Experience:

• Master’s degree in a scientific field (Bioengineer, Pharmacist, Biochemistry or Biotechnology) or equivalent through experience
• Project management capabilities
• Good technical writing style
• Structured towards project documentation
• Can prioritize and work in a structured manner towards deadlines
• Works quality-consciously and accurately
• Enjoys working in a team