Technical Equipment Projectingenieur (GMP)

For a manufacturing customer in Limburg, we are searching for a freelance Projectingenieur to guide the suppliers in developing a specific equipment. This role is aligned to candidates with an experience in engineering/project management in equipment development who would like to switch to a role where you act as a buyer and implementor of equipment, rather than being the engineer developing it. Depending on the project you will have full ownership of the process: alignment on product specifications, setup machine requirements, align requirements with suppliers, setup test specifications, guide the installation and commissioning, owner of FAT and SAT and shared responsibility in validation IOQ together with the validation team.

There are no expectations to design equipment, but if you have an understanding of equipment design, you can improve setting up the correct requirements. You should be familiar with design processes and can guide the supplier better in design reviews and acceptance criteria for the design.

Responsibilities: 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 organisation and equipment vendors.

Rather than personally engineering the machine, guide and challenge suppliers developing the equipment. 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. GMP experience is helpful, but the underlying capability seems more important: someone who knows how to interpret a regulatory/standards framework and engineer against it.

Scope: Equipment implementation using the V-model; Requirements engineering – Knowing and having 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.

Additional Details: SENIORITY Medior/Senior; START DATE October/November; DURATION 12 Months; EXTENSION Yes; CONTRACT Freelance; LOCATION Limburg; ONSITE POLICY 3-4 days per week; HOURS PER WEEK 40; LANGUAGES Fluent Dutch and English; INTERVIEW PROCESS 1-2 stages.