Senior Specialist, Engineering - Biological Drug Development - (Near Lucerne)
Clintec currently has an exciting opportunity for a Senior Specialist, Engineering to work at our global client's biological drug development and manufacturing site located in the Greater Lucerne area. This is an excellent opportunity for the right candidate to join our growing, global company on a permanent, full time basis.
Main accountabilities include but are not limited to:
Management of Equipment Qualification Projects and Computer System Validation Projects for laboratory equipment as well as manufacturing equipment.
Develop, review and approve Validation Plans, Specifications, Test Scripts, Installations Qualification Protocols, Operational Qualification Protocols, Performance Qualifications Protocols, Traceability Matrices and Summary Reports
Perform Equipment Qualification/ Computer System Validation tests
Generate/review Standard Operating Procedures related to Equipment Qualification
Administration of Equipment Change Controls in TrackWise System
Required Experience & Qualifications:
Bachelors/Master’s degree in Engineering, Life Sciences or another closely related discipline
3-5 years of work experience in pharmaceutical environment
Significant practical experience with Equipment Qualification and Computer System Validation
Strong project management skills with the ability to prioritize assignments
High level of accuracy and quality of work
Demonstrated problem-solving skills with the ability to prioritize, align and simplify, used to manage multiple projects with changing priorities
Strong collaboration skills with the ability to work across boundaries and to develop sustainable professional relationships on all levels of the organization
Strong customer focus and solution orientation; proven ability to deliver practical solutions and to drive results
Excellent communication and interpersonal skills
Fluent in English and German, both verbal and written
If you feel you have the relevant experience please apply now or send your CV to Adam Davis, Senior Global Resourcing Executive - firstname.lastname@example.org
Clintec is a dynamic, UK headquartered, privately owned, full service Contract Research Organisation with a presence in over 50 countries worldwide. We have been providing clinical research support services to clients in the pharmaceutical, biotechnology and medical device industries and assisting in their key product development efforts for over two decades. At Clintec we have experience in managing clinical trials in all major therapeutic areas including oncology, rare disease, neurology, cardiovascular, psychiatry, infectious disease, rheumatology, immunology, respiratory and gastroenterology.
Clintec employees can expect to receive expert training and guidance throughout their careers as well as the opportunity to be involved in every aspect of Clinical Trials across the full life-cycle of the drug development process from the CRO perspective. We have strong partnerships with some of the world's leading pharmaceutical companies and employees can expect to be involved in some of the most prestigious drug development projects with the opportunity to develop, progress and travel globally. Clintec offers a competitive salary and rewards package.