Validation Engineer
Job brief
- Independently plan, perform and/or coordinate validation projects to ensure timely completion.
- Draft and coordinate execution of process validation and equipment qualifications (IQ, OQ, PQ, FAT’s, SAT’s).
- Draft/or provide technical guidance for SOPs and other master documents.
- Remain current with industry and regulatory agency trends.
- Keep Tech Ops Management informed of the status of validation activities and projects.
- Support Engineering and Operations in the development of critical process parameters.
- Provide technical leadership for deviation investigations.
- Analyze data and provide recommendations for improvements in manufacturing process, and equipment.
- Prepare and execute protocols, Engineering Studies, and other technical documents, and participate in the interpretation of data, collaborating with other departments.
- Own and Execute Audit Role as the Support / Research SME collecting data to support Audit Requests for the Validation/Calibration Department for all areas of validation
- Other responsibilities as directed.
- Conduct peer-review of protocols and reports.
- Position may require occasional travel and working with validation consultants and the validation team located at the North Carolina site
Requirements
Education Requirements
- Position requires a Bachelors degree in a scientific field
Work Experience Requirements
- Minimum 1 to 2 years of industry experience in pharmaceutical or biotech involved in equipment and/or process validation.
- Experience with equipment calibration is a plus
- Experience with cleanrooms, equipment data bases and building management systems is a plus
Additional Requirements
- Superb attention to detail and ability to meet deadlines.
- Strong understanding in the qualification of steam and dry heat sterilization, and Water for Injections systems.
- Results-oriented, able to make independent decisions, and able to prioritize work per business needs in a fast-paced environment.
- Excellent understanding of cGMP/GLP validation requirements and current industries practices.
- Strong written and verbal communication skills.
- Strong project management skills.
About STALLERGENES GREER International AG
Stallergenes Greer is an international biopharmaceutical company specialized in the research, diagnosis and treatment of respiratory, food and venom allergies through the development and marketing of Allergenic Immunotherapy treatments.
Our mission is to offer the full potential of precision medicine to improve the quality of life of people suffering from allergies.
Allergenic Immunotherapy (AIT) is the only treatment for respiratory allergic diseases that allows for a lasting re-education of the patient’s immune system by inducing an increasing tolerance to allergens.
With more than 1,100 employees worldwide, and production sites in Europe and the United States, Stallergenes Greer offers its medicines in 44 countries.
Would you like to participate in the development of a world expert group in its field, in a dynamic and multicultural environment?
Join our Stallergenes Greer teams!
- Job category : Other
- Job type : Full time
- Contract type : Permanent contract (CDI)
- Job location : United States
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