This job has expired

Validation Scientist

Employer
Eurofins Lancaster Laboratories
Location
Sanford, FL
Closing date
Oct 14, 2021

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Sector
Science
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Job Description

* Recognized as a Quality Subject Matter Expert having extensive knowledge in equipment/instrumentation qualification, validation, requalification, and verification life cycle
* Responsible for cleaning and process validation life cycle
* Responsible for assay validation life cycle
* Supports audits and to expertly review/approve technical content ensuring both scientific merit and compliance to regulatory agency regulations and client policy and standards
* Has sufficient knowledge of internal and external compliance with applicable regulations regarding equipment/system verification
* Familiar with protocol non-conformances of complex technical issues and able to independently handle investigation of non-conformances across cross-functional work areas
* Providing Quality Review/Oversight of site cGXP documentation related to the operation of a vaccine manufacturing facility/laboratory to ensure compliance with global regulatory agencies and quality standards
* Responsible for final authorization/approval/release of documentation/equipment/processes
* Independently completes a variety of assignments and non-routine assignments with minimal guidance
* Organizes and provides written and/or oral presentations of work with minimal input
* Interacts constructively and shares experience of quality approaches with team members developing key partnerships and actively sharing knowledge and expertise in the importance of regulatory compliance
* Can set priorities for self for delivering on critical activities with high business impact

Qualifications

* Bachelor's degree in a scientific or engineering discipline or similar, with a minimum of 8-10 years directly related experience in the biotech or pharmaceutical industry.
* Previous experience creating, executing and/or reviewing IQ, OQ and PQ validation protocols, test scripts, validation schedules, risk assessments, reports, traceability matrices, and validation summary reports
* Knowledge of Regulatory Requirements, 21CFR11, Data Integrity Guidance, GAMP, Lean Six Sigma continuous improvement processes, and industry best practices for validation to complete tasks
* Proficient in analyzing and troubleshooting problems, identifying solutions, recommending, and implementing methods, procedures and/or techniques for resolution
* Capable of managing multiple sub-projects, duties and tasks
* Effective at communicating clearly and concisely, both orally and in writing
* Able to work both independently and as a member of a cross-functional project team in a fast-paced environment
* Preferred experience with DeltaV automation, LIMS, and Global Quality Tracking System (TrackWise)
* Authorization to work in the United States indefinitely without restriction or sponsorship
* Valid driver's license and personal transportation

Additional Information

Position is full-time, Monday - Friday 8:00am - 5:00pm. Candidates currently living within a commutable distance of Sanford, NC are encouraged to apply.

* Excellent full time benefits including comprehensive medical coverage, dental, and vision options
* Life and disability insurance
* 401(k) with company match
* Paid vacation and holidays

Eurofins is a M/F, Disabled, and Veteran Equal Employment Opportunity and Affirmative Action employer.

Eurofins is a M/F, Disabled, and Veteran Equal Employment Opportunity and Affirmative Action employer.
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