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Automation Engineer

Progress-PME is looking for Automation Engineers

Job description:

As Automation Engineer, Progress-PME can deploy you in several areas. You may play an important role at the implementation, qualification and validation of automated systems at our customers. You may be responsible for drafting, review and approval of specifications, protocols and reports and you can be in charge of the execution of qualification and validation activities. The activities must be performed in accordance with the current GMP regulations (EU (EMA) and/or FDA) for which validation methods such as GAMP (5) are used. You may act as intermediate between all departments involved with the validations.  

You are involved in large or smaller projects in the pharmaceutical industry, bio technology or health care. Depending on the size of the project, you take part in a project team, you work independently or you organize and manage the validation activities within a project or project part as project manager. You can be responsible for the final project result: protocols, execution and reporting of the qualification and validation activities, development of SOP’s, solving of punch list items and hand-over to the customer. 

Our job requirements:

  • at least a completed degree programme at Higher Professional Education (University of Applied Sciences (BSC level) or University (MSC level)) in (industrial) automation, measurement and control, technical computer science or similar;
  • at least 4 years of relevant work experience in biotechnology or pharmaceutical industry;
  • extensive knowledge of pharmaceutical production and cGMP regulation (for instance: 21 CFR Part 11 and EU GMP Annex 11, including current requirements in relation to data integrity) and of the latest developments on qualification and validation, including the relevant regulations;
  • knowledge of PLC-SCADA, DCS and of the ISA S88 and S95 standards.
  • familiarity with risk based validation methods such as GAMP (5);
  • recent experience with writing of specifications such as URS, functional specifications and detailed design specifications;
  • recent experience with software-validation of automated data processing systems such as PLC, MES, LIMS, EBR, ERP systems as well as data processing software of  laboratory and production equipment;
  • recent experience with writing of validation protocols and reports, validation master plans and other qualification and validation documents;
  • good communicative skills, both oral and written;
  • good mastering of Dutch and English.

 Your profile:

  • result driven and pro-active attitude;
  • used to work as a team player and being able to deal with the constant tension between achieving due dates and delivering quality;
  • persuasive, motivating, flexible, accurate and decisive;
  • used to communicate and report at both management and executive level;

 What we offer:

  • varied position in a dynamic company with a highly collegial working atmosphere;
  • challenging jobs in different organizations and multiple projects;
  • opportunities to develop yourself, both with respect to hard and soft skills;
  • possibility to have flexible working hours and/or part time job for a good balance between work and private;
  • competitive salary and an excellent remuneration package, including e.g. lease car and of course the opportunity to attend training sessions and congresses.

More information?
For more information regarding the job offer please contact Marcel van Putten, HR Manager, or Octaaf Bos, Operational Director, telephone number: +31 235635016.

Your reply:
Interested? We invite you to send your CV and cover letter briefly stating your motivation to: Progress-PME, Bijlmermeerstraat 20, 2131 HG, Hoofddorp, attn. HRM Department, or by email via the contact button on the website.

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