Equipment Validation Engineer
- Groniningen
- 3500.00 - 5500.00
- 32-40 hours
- Bachelor degree
Client
Our client is a leading consulting and engineering firm in pharma, food and chemistry.
Client
Our client is a leading consulting and engineering firm in pharma, food and chemistry. They participate in interesting projects in the pharmaceutical industry. They do this by providing support to clients on challenging and varied projects. Usually with the opportunity for personal development in addition to your contribution.
Requirements
- Mechanical / Electrical / Engineering degree or related fields. Bachelor is a minimum.
- Minimum of 7 years of experience in a Manufacturing and/or Industrial Engineering role in medium to high volume manufacturing
- Experience in a highly regulated industry, experienced with cGMP
- Hands-on mentality and strong collaboration with all teams
- ICT Skills: Microsoft Office, Minitab
- Experience with validation within a medtech, pharma or other highly regulated sector.
- Experience with data analysis, Structured Problem solving, create reports and documentation and present results.
- Excellent analytical capabilities with a drive to challenge the status quo; eager to learn; puts the team first; robust and passionate to follow given objectives; uses failure as learning experience; excellent communicator with a high sense of urgency.
What do you get?
- Pension entitlement as from day one
- Collective WGA / WIA insurance
- NBBU / ABU collective labor agreement
- 25 holidays days
- 8,33% holiday allowance
- 100% payment in case of illness after one waiting day
- Travel allowance
Duties
We are looking for an ambitious and experienced Equipment validation Engineer for equipment implementation and validation activities. You will work in full collaboration with the engineering teams as a process technology & equipment validation expert to help deliver solutions to meet the design requirements, quality and the business targets.Responsibilities:
- Technical writing of protocols and performing validations in collaboration with Subject Matter Expert (SME))
- Gather requirements, and/or user stories, specifications and write (URS, TM, FAT, IQ OQ, PQ.) for machines & equipment including the software component.
- Create and execute test protocols, Write reports of protocol outputs,
- Handling deviations and/or defects and communication with Validation Review Board (VRB)
- Communication with and support of other departments such as R&D, Quality Assurance (QA), Operations, External suppliers etc within the scope of work defined by the project deliverables.
- Implement new equipment validation in a way that enables seamless global scaling of the equipment and processes within our organisation.
- Design, develop and implement test plans, validation documents and be accountable for the delivery and completion of those activities.
- Support technical and process improvement projects for machining equipment but also optical setups and vision systems
