Senior Validation Technician - Switzerland
Location: Switzerland - North.
This career is for those with a technical mind and a knack for problem solving.
A validation technician tests, monitors and evaluates machinery, equipment and processes to ensure conformity to validation criteria.
Follow a Validation Master Plan.
In addition, the processes, systems and equipment that lead to their manufacture are closely scrutinised too.
Validation assessment can include scrutinising selectivity, specificity, accuracy, repeatability or many other factors. Results of validation testing will be analysed and compared to either internal or external standards. Any deviation from this standard will require immediate corrective action. With validation testing occurring throughout the manufacturing process, the area of concern if a deviation from standard is found, is usually quite limited.
Establish documented evidence which provides a high degree of assurance that equipment and processes will consistently produce a product meeting its predetermined specification and quality attributes.
Perform IQ, OQ, PQ qualification/validation on processes, equipment and systems in conjunction with the given validation plan
Assure that all validation test procedures are in line with current technology, corporate and governmental regulations.
Testing includes: working directly with a Validation Program Manager (VPM) to review, understand and execute test instructions.
Review reports using data from Process Validation, In-process Manufacturing Testing In-process QC testing, and Finished Product QC testing.
Prepares validation project schedules within the manufacturing team, to allow a timely data collection
Author and review work instructions and general work procedures
Working closely with all departments.
Utilizing the lifecycle approach, the successful candidate will insure activities are performed in accordance with the Site Validation Master Plan, project specific Validation Plans, and applicable SOP’s.
Execute validation plans, schedules, protocols and reports for systems that may be complex in nature, to support clinical and commercial manufacturing.
Reviews protocols, reports and data tables generated by peers and contract personnel, analyzes test results and represents the department on cross-functional project teams.
As required, assists in preparation of regulatory submissions and presents validations in respective R&D areas to regulatory authorities during routine internal and pre-approval inspections.
Uses judgment, creativity, and sound technical knowledge to obtain and recommend solutions.
Demonstrated ability to prioritize, manage and schedule in a high throughput R&D environment to meet project and department objectives while maintaining quality goals.
- The ideal candidate will either have a degree and some industry knowledge or be very practically minded with lots of relevant experience
- Has Specific experience in Medical Devices R&D and Manufacturing Certificate.
- You will need to have a strong analytical mind to understand and compile data, create tests but also hands-on in building test equipment and supporting lab based experiments
- 2+ years of demonstrated work experience in a technician role
- Need basic understanding of English
- You will require a background in validation or process engineering in a life sciences company, working to GMP standards. Experience in applying lean techniques is highly desired.
VALIDATION / R&D / DEVELOPMENT / DESIGN / PRODUCT DEVELOPMENT / CERTIFICATION / IVD / IVDR / MDD / MEDICAL DEVICES / ISO 13485 / AUDITOR / AUDITING / ASSESSOR / NB / CE / CE MARKING / TECHNICAL / REVIEWER / SPECIALIST / CLINICAL / BIOMEDICAL / MEDICAL / HEALTHCARE / SCIENTIFIC / ENGINEER / ENGINEERING / CERTIFICATION / NOTIFIED BODY / USA / UK / UNITED KINGDOM / EUROPE / Amsterdam, rotterdam, Eindhoven, Antwerp, Maastricht, leuven, breda, Alkmaar, Netherlands, Europe, drachten, Arnhem, Leeuwarden, Groningen, assen, leiden, holland, arnhem, nederland, Nijmegen / FRANCE, PARIS, MONACO, MONTPELLIER, PERPIGNAN, GRENOBLE, TOULON, TOULOUSE, LYON, DIJON, LILLE, BORDEAUX, ORLEANS LE MANS, NANTES, BREST, RENNES, LIMOGES, GENEVA, EUROPE, BRUSSELS, BELGIUM, GHENT / GENK / AUSTRIA / ANTWERP / BRUGES / MONS / LEUVEN / RENNES, CAEN, DIJON, MARSEILLE, CLERMONT, LA ROCHELLE, BREST, STRASBOURG, GRENOBLE, LUXEMBORG, GENEVA, CALAIS, AMIENS, VERSAILLES, ORLEANS, BOURGES, LE MANS, LE HARVE, LENS, VANNES, POITIERS, NIORT, MACON, DREUX, EVREUX, BEAUVAIS, COMPIEGNE, CHARTRES, BLOIS, TROYES, FECAMP, SENS / MUNICH, BERLIN, FRANKFURT, DUSSELDORF, MANNHEIM, BREMEN, BONN, HAMBURG, BREMEN, STUTTGART, DORTMUND,LEIPZIG,HANOVER,NURNBERG, LEVERKUSEN, FREIBURG, WOLFSBURG, HOFFENHEIM, AUGSBURG, NURNBERG, WIESBADEN, FURTH, COLOGNE, WURZBURG, Recklinghausen, DARMSTADT / MAINZ / HANAU / RHEIN / KOBLENZ / BUTZBACH / SAARBRUCKEN / METZ / HEIDELBERG / KARLSRUHE / BASEL / ESSEN / MUNSTER / BIELEFELD / LUXEMBURG / BRUNSWICK / WOLFSBURG / DRESDEN / CHEMNITZ / BAMBERG / ULM / ROSENHEIM / AUSTRIA / VEINNA / KOPENHAGEN / STOCKHOLM / ITALY/ROME/MILAN/PALERMO/SAN / MARINO/BOLOGNA/GENOA/MONACO/VENICE/VERONA/TURIN/NAPLES / SWISS / SWITZERLAND / GENEVA / BERN / ZURICH / LUSERNE / BIENNE / BASEL
- Validation Engineering