Job Description
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 trouble-shooting 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 M-F 8am to 4pm. Candidates currently living within a commutable distance of Lancaster, PA are encouraged to apply.
What we Offer:
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Eurofins USA BioPharma Services is a M/F, Disabled, and Veteran Equal Employment Opportunity and Affirmative Action employer.