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1 Vacancy
Coordinating instrument maintenance and qualification;
Serving as technical expert for both instrument hardware and software;
Supporting new and existing systems through installation configuration validation procedure development/review training troubleshooting and software/firmware management;
Assist validation personnel in determining approach to validate new technologies providing technical and/or regulatory support;
Research instrumentation with information obtained from vendors manuals industry resources and other staff performing similar functions;
Work with validation group and assist in writing validation protocols test scripts and related documentation in accordance with established validation program; review and assess documents written by validation personnel for approach GMP compliance consistency and thoroughness consistent with internal validation procedures;
Coordinate installation and execution of validation testing document results assess documentation generated by vendors or other validation personnel and summarize results obtained identifying compliance with the test plan;
Perform instrument troubleshooting and operational training when required
Qualifications :
BSc in Science (Chemistry Physics or Similar) Engineering Degree 5 years of experience managing equipment/instrument in a cGMP environment (CSV FDA CFR Part 21 compliance) MSc in Science (Chemistry Physics or Similar) Engineering Degree 3 years of experience managing equipment/instrument in a cGMP environment (CSV FDA CFR Part 21 compliance)
This is not an IT position and candidates with theoretical IT and server maintenance experience are not preferred.
Additional Information :
Working schedule will be MF 8am to 4pm. Candidates currently living within a commutable distance of Lancaster PA are encouraged to apply.
What we Offer:
#LIEB1
Eurofins is a M/F Disabled and Veteran Equal Employment Opportunity and Affirmative Action employer.
Remote Work :
No
Employment Type :
Fulltime
Full-time