Technical Equipment Project Engineer
For a manufacturing company, a project engineer with hands-on machine experience is sought to guide suppliers in developing specific equipment. This role is aligned to candidates with experience in engineering/project management in equipment development who would like to switch to a role where you act as a buyer and implementer of equipment, rather than being the engineer developing it. Depending on the project, you will have full ownership of the process.
There are no expectations to design equipment, but an understanding of equipment design can help in setting up the correct requirements. You should be familiar with design processes and can better guide the supplier in design reviews and acceptance criteria for the design.
What you will do.
- Translate process/product/business needs into clear equipment requirements and specifications.
- Draft user and functional requirements, define acceptance criteria and associated test cases, and maintain traceability between requirements and verification.
- Apply requirements-engineering principles rather than simply writing a purchasing specification.
- Determine what needs to be controlled and tested based on equipment/process risk.
- Participate in or lead FMEA/risk assessments, translating identified risks into design requirements, controls, acceptance criteria and testing.
- Own or coordinate the equipment lifecycle using a V-model approach: user/process needs → requirements/specification → supplier design/development → testing/verification → acceptance/implementation.
- Ensure that requirements established at the beginning are demonstrably verified later in the project.
- Act as the technical interface between the internal organization and equipment vendors.
- Guide and challenge suppliers developing the equipment, rather than personally engineering the machine.
- Review proposed technical solutions, specifications, designs, software/configurations and documentation against the defined requirements.
- Take equipment projects from initial need through specification, supplier engagement, development, acceptance and implementation.
- Coordinate engineering, users/process owners, quality/regulatory stakeholders, automation and external vendors.
- Define the verification strategy and test cases and support or lead design reviews, FAT/SAT and other acceptance/qualification activities as appropriate.
- Manage deviations or gaps against requirements and ensure they are resolved before final acceptance.
- Identify the regulations, standards and internal procedures relevant to the equipment and translate them into practical requirements.
Profile
- Equipment implementation using the V-model
- Requirements engineering: proven experience with drafting of requirements including test cases
- Experience with a risk-based approach for equipment acquisition (product needs, requirements, FMEA, process definition, process steps, risk assessment)
- Experience in equipment engineering would be a plus
- Experience with GMP or other regulations; candidates should understand and be familiar with strict legislation and regulations
- Pharmaceutical background is a plus, but other industries like medical, automotive, semiconductors, packaging etc. are also fine
- Experience in automatization is a plus / understanding of software and software configurations
- Fluent in Dutch and English
How to apply
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