Technical Equipment Projectingenieur (GMP)

Technical Equipment Projectingenieur (GMP) voor een productiebedrijf in Limburg, hybride 3-4 dagen op locatie, 40u/week, freelance contract.

Locatie
Limburg, BE
Werkvorm
hybride
Uren
40 uur per week
Sluitingsdatum

De opdrachttekst is gewijzigd; de eerdere beoordeling is niet meer actueel.

Bekijk en reageer bij vividresourcing.com (externe link)

Eisen

  • Experience with GMP or other regulated environments, with a clear understanding of strict legislation and regulations and the ability to interpret a regulatory or standards framework and engineer against it
  • Fluent Dutch and English
  • Experience with a risk-based approach to equipment acquisition, including product needs, requirements, FMEA, process definition, process steps and risk assessment
  • Proven experience in requirements engineering, including drafting requirements and associated test cases
  • Medior or senior level experience in engineering or project management within equipment development
  • Experience implementing equipment using the V-model

Wensen

  • Experience in automation and an understanding of software and software configurations
  • Pharmaceutical background, although candidates from medical, automotive, semiconductor, packaging and similar industries are also welcome
  • Experience in equipment engineering
Volledige omschrijving

Vivid Resourcing is looking for a Technical Equipment Projectingenieur (GMP) for a client, a manufacturing organisation in Limburg, Belgium. The role is designed for engineers or project managers with a background in equipment development who want to move to the other side of the table, acting as the buyer and implementor of equipment rather than the engineer building it. Depending on the project, you will have full ownership of the process, covering aligning on product specifications, setting up machine requirements, agreeing those requirements with suppliers, defining test specifications and guiding installation and commissioning.

You will own FAT and SAT and share responsibility for IOQ validation with the validation team. You will not be expected to design equipment, but an understanding of equipment design will help you set the right requirements, guide suppliers through design reviews and define sound acceptance criteria. The role suits a medior or senior professional who is comfortable challenging suppliers, working with strict regulations and taking a structured, requirements-driven approach.

Main responsibilities: translate process, product and business needs into clear equipment requirements and specifications; draft user and functional requirements, define acceptance criteria and test cases, maintain traceability; determine what needs to be controlled and tested based on equipment and process risk, participate in or lead FMEA and risk assessments; own or coordinate the equipment lifecycle using a V-model approach; act as the technical interface between the internal organisation and equipment vendors; take equipment projects from initial need through specification, supplier engagement, development, acceptance and implementation; define the verification strategy and test cases, support or lead design reviews, FAT, SAT and other acceptance and qualification activities; identify the regulations, standards and internal procedures relevant to the equipment.

Essential requirements: experience implementing equipment using the V-model; proven experience in requirements engineering; experience with a risk-based approach to equipment acquisition; experience with GMP or other regulated environments; fluent Dutch and English; medior or senior level experience.

Desirable: experience in equipment engineering; pharmaceutical background; experience in automation and understanding of software configurations.

The offer: contract engagement of 12 months with extension possible; start in October/November; on-site in Limburg 3-4 days per week, 40 hours per week; rate to be confirmed with candidates; full ownership of equipment projects; opportunity to move from equipment development into a buyer and implementor role; a 1-2 stage interview process.

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