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Senior Engineer (Supervisor), Validation Solothurn Switzerland,  


Posted on : 28 May 2017

Project Description

External Posting TitleSenior Engineer (Supervisor), Validation Job DescriptionJOB PURPOSE:The role is responsible for writing, performance and reporting on validation activities related to biopharmaceutical Facilities, Utilities, Equipment (FUE) and associated systems (e.g. automation). The individual shall be responsible for planning, coordination and driving validation activities from initiation to successful completion. The individual shall act as the primary decision maker for assigned validation responsibilities, including deviation investigations, risk / impact assessment. MAIN ACCOUNTABILITIES:1. Preparation and execution of validation protocols involving facilitates equipment, utilities and associated automation. 2. Preparation, review and approval (as required) of SOPs, validation deviations, change control, validation summary reports and associated documentation.3. Management and co-ordination of validation activities with internal departments, external contractors and suppliers. 4. Prepare and deliver cross functional training in validation methodologies, protocols and related procedures to facilitate validation activities. 5. Primary point of contact for validation related issues arising during validation activities (including protocol execution).6. Investigation of deviations / non-conformances to determine [potential] impact on product quality, validation status and associated compliance requirements. 7. Partners with functional departments to perform deviation root cause analysis and formulate corrective / preventative actions (CAPA).8. Performance of risk and impact assessments associated with validation activities, deviations and changes9. Provides support to commissioning activities, including review of commissioning plans, procedures, turnover packages etc. (as required).10. Performs final review of test data / reports to ensure conformance with established specifications and related standard operating procedures. 11. Provide guidance on validation requirements and expectations to validation engineers and project team. 12. Represent validation as a subject matter expert (SME) in all project phases (including commissioning and qualification execution). 13. Represent the validation program and designated validation activities during inspection by regulatory agencies and Biogen Quality / Regulatory functions.14. Review of technical documents / reports to ensure that validation activities are consistent with current company, industry, regulatory requirements, and current technology. *LI-POT4 LocationSolothurn, Switzerland Job CategoryOperations, Technology & Innovation (PO&T) Requisition Number30527BR Qualifications- 5-8 years experience in a Validation/Quality role in a biopharmaceutical manufacturing environment. Large scale project experience - Thorough knowledge of biotechnological technologies, processes and clean utilities.- Demonstrated proficiency in Good Practice requirements (GMP, GEP) as well as biopharmaceutical industry regulations and norms as they relate to validation. - Strong technical writing and communication skills in English. German an advantage.- The ability to take pragmatic and compliant decisions.- Highly motivated to take ownership and responsibility for assignments. - Ability to take the initiative with minimal supervision- Proficiency in MS Word, MS Excel and MS Project. EducationBachelor of Science Degree (BSc) in an engineering or scientific discipline. MSc in a related discipline preferred. About BiogenBiogen (NASDAQ: BIIB) is a biotechnology leader that discovers, develops and delivers innovative therapies for the treatment of neurodegenerative and rare diseases. Patients worldwide benefit every day from our medicines for multiple sclerosis (MS) and hemophilia. Founded in 1978, Biogen is one of the world s oldest independent biotechnology companies. Our development pipeline is focused on areas of high unmet medical need, as we pursue new therapies for patients suffering from diseases with few or no treatment options. These include programs for Alzheimer s Disease, amyotrophic lateral sclerosis (ALS), Parkinson s disease, spinal muscular atrophy and neuropathic pain amongst others. With more than 7,000 people worldwide, Biogen is truly a global organization. We are headquartered in Cambridge, Massachusetts, which is home to our research operations. Our international operations are based in Zug, Switzerland and we have world-class manufacturing facilities in North Carolina and Denmark. We offer therapies globally through direct affiliate presence in 30 countries and a network of distribution partners in over 50 additional countries. All qualified applicants will receive consideration for employment without regard to sex, gender identity or expression, sexual orientation, marital status, race, color, national origin, ancestry, ethnicity, religion, age, veteran status, disability, genetic information or any other basis protected by federal, state or local law. Biogen is an E-Verify Employer in the United States. Please be advised that all legitimate correspondence from a Biogen employee will come from "@biogen.com" email accounts. Job Segment: Biotech, Developer, Manager, Manufacturing Engineer, CAPA, Science, Technology, Management, Engineering

Locations

Solothurn Switzerland

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