Qualification & Validation Engineer

26 July 2021
SalaryNegotiable
LocationAmsterdam, Gemeente Amsterdam, North Holland
Permanent
DisciplineLife Science Careers, Installation/Maintenance/Repair
ReferenceBBBH461986_1627304233

Are you looking for a dynamic, globally active technology company - yet at the same time, you appreciate a value-oriented, trusting company? We offer you exciting work as part of a team of experts who treat each other as equals. All over the world.
In our biopharmaceutical organization with sites in Germany and the Netherlands we are fast-growing, and we are always looking to attract motivated new colleagues who wish to enhance their development in every phase of life; who share our values and who would like to be part of a family.

At our Amsterdam-based center Wacker Biotech B.V. focuses on the GMP-compliant microbial based production of recombinant proteins, vaccines and live microbials as drug substance and drug product.
We are currently looking to recruit a Qualification & Validation Engineer for our Engineering Department (f/m/d).

The Validation Engineer is mainly responsible for performance of Commissioning, Installation and Operational Qualification (IOQ), Performance Qualification (PQ), Periodic Validation Review (PVR) and Cleaning Validation studies in accordance with European and FDA cGMP, industry guidelines and Wacker Biotech policies and procedures.

Your tasks

  • Write, plan, organize, perform and report Commissioning, Installation & Operational Qualification (IOQ), Performance Qualification (PQ) validation studies and Periodic Validation Reviews (PVR) for equipment, utilities, facilities and processes
  • Actively participate within project teams as a key project team member for validation related activities
  • Coordinate, performance and/or supervision of Factory Acceptance Tests (FAT) and Site Acceptance Tests (SAT)
  • Liaise with departmental representatives, as appropriate, to ensure validated status of equipment, utilities, facilities and processes
  • Keep abreast of industry developments in the field of validation and communicate as appropriate
  • Assess the impact on validated status and/or validation study validity on initiated deviations
  • Define the required validation activities on initiated Change Control Forms
  • Review and approve User Requirement Specifications to ensure validation requirements are fulfilled
  • Write, review and approve Impact Assessment Reports


Your profile

  • At least a Bachelor's (HBO) degree and 3 years working experience in a cGMP environment. Next to this you should have a minimum of 2-3 years experience in commissioning and qualification within the Pharmaceutical, Biotechnology or Medical Device industry
  • The ability to work with tight deadlines and to prioritize and handle multiple projects
  • Profound knowledge of Dutch and English language, has excellent verbal / written communication skills
  • Computer fluency in MS Office, e.g. Office, Excel, Word. Knowledge of TrackWise is a plus
  • You reside in and are eligible to work in The Netherlands (valid work permit)

For more details contact our recruitment partner Kelly Services
Sari Steenhauer - 0031 (0)6 33 13 77 46
When interested please react through the application process with your English resume.

Be part of a family. Across all nations.
About Kelly Services
It's more than a job. It's passion.
Our vision is to provide the world's best workforce solutions. We are authentic, the industry founder. We believe in relationships, not transactions. We value teamwork, realizing that we are stronger together than as individuals. We take seriously the promises we make. We are passionate, dedicated and driven to excel. With us it has never been about being the biggest. It has always been about being the best and doing the right thing.

At our core, we are a community. Each day we welcome into our community the varied talents of all people who embrace our culture of service, teamwork and integrity. We offer the opportunity to work with the best companies in the world, and to make a difference in the communities in which we live and work.

Met betrekking tot deze functie fungeert Kelly Services als officieel bemiddelaar. Wanneer je de beslissing maakt om op deze functie te solliciteren zullen jouw gegevens in overeenstemming met Kelly's Privacy Statement worden verwerkt.

Met oog op de AWGB (Algemene Wet Gelijke Behandeling) verwelkomt Kelly Services sollicitaties van iedere geschikte kandidaat, ongeacht etniciteit, geslacht, beperking, religieuze overtuiging, seksuele geaardheid of leeftijd.

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Regarding this role, Kelly Services acts as the official mediator. When you decide to apply to this role your personal information will be processed in accordance with Kelly's Privacy Statement

In keeping with the AWGB (Algemene Wet Gelijke Behandeling) Kelly Services welcomes applications from any and all eligible candidates regardless of ethnicity, gender, disability, religion, sexual orientation or age.