Senior Engineer

Orion Group Life Sciences are looking for a Senior Engineer (Senior Equipment Engineer) for our Multinational Pharmaceutical/Biotechnology client based in Breda. Initial 12-month contract, with high possibility of extension. This is a mainly fully onsite role.

What will you do

Equipment Engineer is responsible for scoping and executing technical projects supporting manufacturing withing Device Assembly, Inspection, Labelling and Packaging areas. He/she is responsible for overseeing the design, installation, and lifecycle of all equipment used in the operations. This role involves collaborating with cross-functional teams to ensure efficient equipment performance, troubleshooting equipment failures, and implementing improvements to optimize productivity and safety.

Main Responsibilities of the role

• Technical Leadership & Project Execution
  • Technical lead for assigned equipment or process area within an OPEX/CAPEX project.
  • The primary technical contact between internal stakeholders and equipment vendors.
  • Translate user and process requirements into clear technical specifications and design expectations.
  • Partner with the Project Manager to align on timelines, risks, and technical deliverables.
• Design Engineering
  • Coordinate the detail engineering and responsible for creating design documents: User Requirements Document (URS), Functional Specification Document (FDS), Hardware Design Specification (HDS) and Design Review (DS) based on compliance and user requirements.
  • Prepare and execute characterization challenges through experiments in which parameters are intentionally varied to determine their effect on the area effectiveness and performance.
  • Support FAT and SAT together with the engineering team
  • Overseeing the installation, testing, and commissioning of equipment systems to ensure proper functionality and performance.
• Day-to-day
  • Working with various stakeholders to scope projects and ensure equipment designs meet the required specifications and standards.
  • Project management and execution of assigned projects including project prioritization, resources management, status management and external communication.
  • Troubleshooting and resolving equipment-related issues.
  • Development of detailed specifications, engineering documents, and protocols (URS, FDS, HDS, DS).
  • Work in a collaborative manner within the Process Teams structure and contributes to Root Cause Investigations and Cross Functional Investigations.
  • Perform all tasks with due care and attention ensuring compliance with Good Manufacturing Practices and company requirements, policies and procedures.
  • Support a safe working environment by complying with environmental health/safety practice, rules and regulations.

Qualifications and skills

• BS degree or higher in Mechanical Engineering or relevant + experience.
• Typically, 6+ years of relevant work experience with 4+ years in operations / manufacturing environment, preferably in pharmaceutical environment or automated device assembly, labelling and packaging processes.
• Hands-on experience with commissioning activities.
• Strong knowledge of equipment design, installation, and maintenance processes.
• Direct experience with regulated environment (e.g. GMP, OSHA, EPA).
• Occasionally work outside office hours.
• Fluency in English, both in oral and written communication.
• Knowledge of (personal) computer software, specifically: MS office.

If you would like to have a confidential conversation regarding this opportunity, please reach out to Tim Browaeys, tim.browaeys@orion-jobs.com or contact Tim on 0044 7593448607
 
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