2 days ago

Sterilization, Cleaning & Equipment Validation Expert

962 BAXALTA BIOSCIENCE MFG SARL

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Sterilization, Cleaning & Equipment Validation Expert

Sterilization Cleaning Equipment Validation Expert
Shire Shire is the leading global biotechnology company focused on serving people with rare diseases and other highly specialized conditions. We have best-in-class products available in more than 100 countries across core therapeutic areas including Hematology Immunology Neuroscience Lysosomal Storage Disorders Gastrointestinal/Internal Medicine/Endocrine and Hereditary Angioedema a growing franchise in Oncology and an emerging innovative pipeline in Ophthalmics. CIP SIP and Equipment Validation Expert Job Description Shire's Neuchatel validation team is accountable for all engineering and process validation tasks in alignment with global validation organization and according to regulatory guidelines. We are currently looking for a highly motivated Validation Expert for our engineering validation team. This is an exceptional career opportunity for an ambitious operational excellence minded and change agile validation professional with a track record of successfully taking a Validation Expert role within a world-class manufacturing environment ideally within the Biotech Production field. As Validation Expert you will report directly to the Validation Manager and be responsible for planning execution and reporting of validation tasks within the validation department. The role responsibility covers creating executing and enhancing facility equipment utility cleaning and sterilization validation activities for the site. As Validation Expert you will have an active involvement in continues improvement development and implementation of new initiatives. You will assure issue resolution arising from validation activities in cooperation with QA Technical Operations and Manufacturing e.g. deviation handling CAPA and change requests . The role is expected to have a solid understanding of industry standards and validation compliance requirements and is required to supply support/technical knowledge for the development/refinement and implementation of validation standards. Your mission The CIP and SIP Validation Expert performs troubleshoots and supports the manufacturing qualification activities. He/she performs a variety of activities to support CIP/SIP and Equipment validation. He/she represents the validation on project teams and interfaces with peers in various other departments such as engineering and manufacturing to ensure that design implementation and qualification processes are conducted according to established quality standards. Essential Duties Responsibilities Maintain and develop expertise in CIP/SIP and Equipment Validation according to Shire and Regulatory standardsWrite review and approve CIP/SIP and Equipment Validation documents validation protocols SOPs CQP DP RIAS MVP...etc. according to Shire and Regulatory standardsParticipate in CIP/SIP and Equipment validation activities from strategy planning execution to validation reportCoordinate and follow-up validation protocols execution ensuring that all validation activities and documents are completed and documented in a timely manner.Provide Validation Expert support related to strategy definition problems solving root cause analysis CAPAs investigation and implementation stepsParticipate in internal or external audits as required. Follow-up on audit observations topics and ensure closure on time Required Skills We are looking for a strong energetic team player with good communication skills capable of dealing with complex and divers situations.Demonstrated interpersonal and expertise skills with ability to interface well with other departments and lead effectively and efficiently validation engineering topicsAbility to manage multiple priorities in a manufacturing plant settingAbility to analyze review and interpret engineering validation dataMust have uncompromising dedication to quality and an excellent understanding of CGMPs and other regulatory guidelinesInterpersonal skills that enables you to work with people at all levelsAbility to plan multitask and manage time effectivelyMust display personal accountability for results and integrityMust display eagerness to learn to innovate drive for solutions and continuously improvement Requirements Engineering degree or equivalent preferably with biochemical or chemical backgroundAt least 7 years' engineering validation experience in the pharmaceutical/biotechnology industrycGMP and validation skillsBroad validation knowledge industrial trends and validation related literatureSolid computer skills including Word Excel PowerPoint.Very good English level oral and written Very good French level oral and written Starting September 2017

Pierre-à-Bôt 111 2000 Neuchâtel