COMPUTER SYSTEM VALIDATION CONSULTANT
Iperion, founded in 2005 and located in Vlijmen, is specialised in information systems, GxP cloud
computing and consultancy services for companies operating in the life sciences industry. With a team of
highly skilled professionals we work closely together with our customers to establish the best possible
information systems to support their business. The high customer satisfaction ratings underline the
appreciation the market has for our expertise, drive and dedication.
Within our young and enthusiastic team we have a position vacant for an experienced computer system
validation consultant, who is able to manage and execute the implementation and validation of information
systems.
Responsibilities
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Plan, schedule, execute, and lead life sciences validation projects including: implementation of new systems
and re- validation of existing computerized systems;
Evaluate, define, and develop clients’ technical and regulatory needs and make recommendations;
Prioritize, manage, and execute multiple projects utilizing Project Management methodology;
Perform business development activities with both new and existing clients.
Review and approve validation project documentation;
Assist in second line and highly critical support incidents.
Requirements
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Bachelors degree in computer science, computer engineering, life science, or any other pertinent degree;
Minimum of 3 years of experience in a highly regulated environment: pharmaceutical, biotechnology or related
industry;
2 to 3 years of experience in project management (preferred);
In-depth knowledge of FDA and European compliance regulations and GAMP guidelines applicable to
computer system validation;
Familiar with off-the-shelf, configurable, and custom-developed applications;
In-depth knowledge of validation deliverables associated with each step of the computer system life cycle;
Possess strong analytical and decision-making skills;
Possess excellent verbal and written communication skills in Dutch and English;
Analytical, customer focus, empathic, reliable, accurate, service oriented;
Willingness to travel (app. 20% of the time);
Result oriented, flexible, drive, enthusiastic, independent, motivator.
Qualification and Skills
At least 5 years international project management experience, preferably in IT solutions (for the life sciences
industry);
Knowledge of and experience with Project Management methods and preferably in the possession of a Prince 2
certificate and/ or ITIL;
University or HBO degree;
Willingness to travel;
Strong communication skills in Dutch and English;
Multidisciplinary;
Analytical, customer focus, empathic, reliable, accurate, service oriented;
Result oriented, flexible, drive, enthusiastic, independent, motivator;
Valid driving license.