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Project Validation Engineer

NL1115

DPS Group Global is currently looking for a Project Validation Engineer who is responsible for the long-term planning, development, qualification and implementation of next generation manufacturing processes and automation technologies.

Category:
Validation
Location:
Netherlands
Years of Experience Req.:
>2 years
Date Posted:
03/06/2019
Days Remaining:
17
Employment Type:
Contract
Education Level Req.:
Bsc or Msc degree

DPS

DPS is a leading Project Management and Engineering Company serving industry around the world for 40 years. Our reputation is based on forming successful partnerships with our clients, providing them with innovative designs and cost effective solutions in the context of sound judgment, strong management and technical excellence.
We provide Full Service Engineering for our clients including Project and Programme Management, Procurement, Design, Construction Management, Health and Safety Management, Commissioning, Qualification and Start-up on numerous projects across a range of market sectors. Our Main market sectors are; Pharmaceutical and Biotechnology, Medical Technologies, Oil & Gas, Advanced Technology, Science & Education, Food & Beverage, and Energy.

 

Responsibilities 

  • Lead equipment and process improvements projects
  • Responsible for performing and documenting activities for IQ, OQ and PQ
  • Follow compliance and EHS&S policies and guidelines
  • Identify, quantify, and implement opportunities to reduce cost of goods
  • Support closure of NCRs, CAPAS, audit observations, ergonomics and safety related action items
  • Work with vendors to procure new equipment and ensure new equipment and processes conform to EHS&S guidelines
  • Technical writing, data analysis, data tracking and trending
  • Manage manufacturing process based projects, in line with agreed targets and priorities of Business Units.
  • Serve as the process and equipment engineering to support manufacturing
  • Serve as the engineering approver for process development studies and validation documentation when authoriz851207.484508ed
  • Apply project management methodology to deliver on process improvements, new process implementation & equipment development/Improvement
  • Lead technical investigations and feasibility studies as required for specific projects/tasks.
  • Provide technical information on appropriate areas to all functions within the business.
  • Exercises technical judgment within broadly defined practices and policies in selecting process development and validation strategies.
  • Provide the technical input to plan, design, develop, and validate the manufacturing processes for new products working with cross-functional teams including: R&D, Quality Engineering, Regulatory, Procurement, Manufacturing, and Environmental/Safety.
  • Conceive, develop and implement equipment / tooling and support the respective equipment installation qualification activities.
  • Accountable for appropriate improvement and execution of process and validation activities at external suppliers as required.
  • Provide project updates and presentations to all levels of the business.
  • Ensure all activities are carried out in accordance with appropriate internal and external Health, Safety & Environment procedures and safe working conditions and practices and supporting documents are in place. Observe all regulatory requirements (GMP's, ISO, FDA, internal policies) applicable to their area of responsibility.
  • Maintain project documentation and files and, where appropriate, suggest improvements to systems and procedures.
  • Ensure all assigned activity is carried out in accordance with appropriate internal and external quality systems.

 

Qualifications

  • Engineering degree
  • Electrical, Automation or Mechanical background with up to 2 to 10 years in industry (Engineer) - with preferably significant Experience in medical environment.
  • Experience in Manufacturing and/or Engineering working on manufacturing processes and improvements
  • Understanding of process variability and process control
  • Lean and/or Six Sigma
  • Project management and resource prioritiz851207.484508ation
  • Strong time, budget, and program management skills
  • Demonstrated experience in the development and execution of project plans
  • Thorough working knowledge of the validation requirements for Medical Devices with demonstrated experience; generate and execute equipment, process, and computer system validation.
  • Demonstrated ability to select and execute the appropriate statistical tools and provide the practical conclusions and inferences during the process development and validation activities.
  • Working knowledge of Six Sigma/Process Excellence Tools (DMAIIC, DMADV, or Lean) which include Design of Experiments, capability analysis, C/E Matrix, pFMEA, fish bone diagrams, etc.
  • Proficiency with Microsoft Office and a working knowledge of statistical software is required. Candidates who have experience using MiniTab are preferred.
  • Good organiz851207.484508ation skills and results oriented
  • Excellent communication skills; making complex issues easy for others to understand and the ability to prepare communications for team and project documentation. Ability to communicate across multiple levels in the organiz851207.484508ation
  • Demonstrated proficiency in regulatory compliance
  • Ability to work in a team environment with a driver mentality
  • Fluent in English, Dutch will be a plus

 

Additional Details

Full time preferred, 32 hours discussable. Looking for 2 validation engineer; 1 being project focused, another non project driven. EN required, Dutch considered a plus. Longer-term may be possible in case of strong performance, but no guarantees can be given at this stage. Sector MD preferred, but flexible also for relevant background in food/pharma/aerospace. Must be available to work onsite in Leiden full time.

 

Available and interested?

If you’re interested in this role and if you want to be part of growing organisation within engineering projects in the pharma industry, please send your application to [email protected] or give us a call +31(0)715730810.

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