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Pharmaceutical Commissioning & Qualification Engineer Consultant (Netherlands)

Régió: Külföld

PBS International Kft.
Hozzáadva: 2016.09.27.
Hirdetés azonosító: 738342
Pharmaceutical Commissioning & Qualification Engineer Consultant (Netherlands)

Country:    Netherlands (+31)

Description of position:    We are looking for Pharmaceutical Commissioning & Qualification Engineer Consultants who will join our client's team of Life Science Services.

Duties:    Required Experience/Tasks:

 Generating Validation Master Plan VMP and Validation Project Plan VPP

 The preparation and execution of commissioning protocols and reports.

 The preparation and execution of qualification protocols (impact assessments, DQs, IQs, OQs, PQs) and reports, including FAT/SAT.

 Performing as part of project teams the walk downs, commissioning and optimization testing of new and modified pharmaceutical installations.

 Documenting the handover / integration of new and modified installations into existing site support processes e.g. maintenance systems.

 Ensuring all commissioning punch list items are completed.

 Ensuring all commissioning and qualification documentation is completed in accordance with site standards and procedures.

 The preparation and execution of annual cGMP direct impact systems periodic review reports.

 Experience with the start-up of process equipment using commissioning protocols, functional testing of systems. Writing & reviewing these protocols and troubleshooting during starting-up phase.

 Analyze and interpret validation data, results and summarize findings in final reports

 Analyze the design to identify the GMP requirements for validation.

 Resolve protocol and execution discrepancies to a satisfactory conclusion and plan follow up actions as required

 Make recommendations and decisions (when appropriate) regarding test strategies and approaches

 Conducting and coordinating validation testing

Requirements, skills:    Education:

University of professional education Chemical / Mechanical / Process, OR

Bachelor Chemical technology or University Chemical engineering

Required experience must be in the Pharmaceutical, high end Food industry related to:

 A minimum of 3 till 5 years work experience with a major engineering or commissioning and qualification activities.

 Pharmaceutical process equipment, such as freeze dryer, autoclave, washer,

 Tableting, fill, finish packaging & labelling lines.

 Pharmaceutical processes such as formulation, fractionation, sterilizing

 Pharmaceutical utilities such as HVAC, SIP CIP, filtration

 QC laboratory equipment

Personal skills:

 Team player, but also able to work independent in projects

 Strong analytical and technical writing skills

 Anticipating attitude is a must

 Fluent in spoken and written English, willingness to study Dutch

 Customer and result orientated.

 Willingness to travel and for project duration to stay in apartment or hotel.

Employment: Staff position with the focus for permanent contract

Location: Office in the Netherlands, project through-out the Benelux

After a pre-selection the client will come to Budapest to have a personal interview with you.

Known languages:    Fluent in spoken and written English, willingness to study Dutch

Short company info:    Our client is a well-known Consultancy & Engineering company with solutions and services for the industry. The company offers general design engineering with a focus on Process and Commissioning and Qualification activities for the pharmaceutical, high-end food and bio-tec branch with projects through-out the Netherlands and Belgium.

Additional info:    By submitting an application form or sending your curriculum vitae electronically, you will be giving the employees of PBS International Ltd. the approval and acknowledgement to access, handle and record the personal details you have submitted for application and registration processing. During the course of your application and in the future event that a prospective party expresses professional interest in you, we will only forward your details onto our clients upon your exclusive and prior approval.

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