Job Description

Coordinating Capillary Electrophoresis, iCE, CD, and MFI 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

Qualifications

Essential Duties and Responsibilities:

• Applies GMP/GLP in all areas of responsibility, as appropriate
• Demonstrates and promotes the company vision
• Regular attendance and punctuality
• 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
• Assist validation personnel in writing and performing 21 CFR Part 11 evaluations and testing for computerized laboratory systems
• 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
• Create procedures for new instrumentation to outline operation, maintenance, and calibration/qualification; maintain, update and edit department specific procedures
• Perform required monthly maintenance and yearly qualification activities on all relevant instruments
• Troubleshoot instrumentation, and enroll the assistance of the vendor when required
• Perform instrument trouble-shooting and operational training when required
• Participate in internal, client, and regulatory audits; develop audit responses and correction actions as necessary
• Conducts all activities in a safe and efficient manner
• Performs other duties as assigned

Basic Minimum Qualifications (BMQ): To perform this job successfully, the individual must be able to perform each essential duty satisfactorily. The requirements below are representative of the knowledge, skill or ability required. (List three to five key quantifiable skills or position requirements that the candidate must have to be considered for this position.)

Education/Experience (BMQ): Bachelor's degree is preferred but not required in chemistry, biology, biochemistry, or related degree concentration and no previous laboratory experience

Additional Information

COMPREHENSIVE BENEFITS PACKAGE & COMPENSATION

• As a Eurofins employee, you will become part of a company that has received national recognition as a great place to work. We offer excellent full-time benefits including comprehensive medical coverage, life and disability insurance, 401(k) with company match, paid holidays and vacation, personal days, and dental and vision options.

• Authorization to work in the United States without Sponsorship

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

Eurofins USA BioPharma Services is a Disabled and Veteran Equal Employment Opportunity employer.

Eurofins USA BioPharma Services is a Disabled and Veteran Equal Employment Opportunity employer.