ALTEN develops and delivers Life Sciences expertise to world-leading companies. Today ALTEN is a key player in Life Sciences (Pharmaceutical industry, Medical Devices…) with over 30 clients. As a global player with a local presence, we are flexible and able to adapt to the needs of every single customer. That’s why we are looking for CQV Engineers to strengthen our team of consultants.The Commissioning, Qualification and Validation (CQV) Engineer will support technical projects and will report to the Validation Manager in the organization. The CQV Engineer has a hands-on attitude, is motivated, accurate and responsible for the CQV part in project at the customer. The CQV Engineer will develop, implement, and report test strategies for technical solutions in accordance with internal customer requirements and standard CQV procedures. Together with a team he or she will drive the development of system commissioning qualification and validation documentation. The CQV Engineer communicates... at all levels within the organization and has a sound (design) experience in pharmaceutical engineering, equipment qualification and pharmaceutical solutions in the Life Science industries.Your main responsibilities are:As a CQV Engineer, you will integrate the life sciences team in the pharmaceutical industry and depending on the projects outline and the focus within the Engineering team at the client, your responsibilities will include but not limited to:Commissioning, qualification and validation activities within a pharmaceutical manufacturing environmentQualification of new equipment for existing or new manufacturing sitesInvolved in all validation activities including facilities, utilities, validation life cycle, technical documentation, execution, validation process, GAP Analysis, risk assessmentInvolved in drafting all validation documentation deliverables include URS, DQ (basic, detailed), FMEA, Risk Assessments, FAT, SAT, Protocols (IQ, IOQ, OQ, PQ).Execution of IQ/OQ and PQ for equipment, systems and utilities and document validation results according to cGMP requirementsWork to identify efficiencies in the validation program approachWork to apply lessons learned and stay informed of industry regulatory changes as it applies to equipment / facility validationPerform assigned Quality Systems activities including Document Management system, Change Control, Non-Conformities, and CAPA’sWriting and/or revising procedures applicable to the Engineering activitiesSupport the Engineering team to prepare the validation, re-qualification, and maintenance program.Involved in requirement traceability matricesWrite and review commissioning, qualification and validation summary reports
Netherlands

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