About this role
Subject Matter Expert (SME) - Maintain instrument/software in a validated state at all times. Perform assessment, trouble-shooting, repair. Develop and implement CAPA to resolve issues as needed. Ensure completion of preventative maintenance and routine qualification testing. Install, configure software for electronic record compliance. Perform testing to identify gaps and develop remediation as required. Routinely analyze system logs/audit trails, perform software/firmware upgrades, update user account information, and complete periodic system compliance reviews.Validation Testing - Determine and/or assist with determining the approach to test and validate instrumentation. Provide technical and risk-based rationale to support approach. Coordinate installation and/or execute testing (as required).Review testing documentation generated by vendors and/or other team members. Compile and maintain documentation in an organized GXP compliant manner to demonstrate status.Applies GMP/GLP in all areas of responsibility, as appropriateCompliance - Ensure projects are completed in compliance with existing quality systems. Stay current with client, regulatory, validation, IT, and e-record regulations and requirements. Assist with implementing new internal practices and procedures.Research - Research and on-board new instrumentation; Assist with integration of instrumentation into existing data center environments and workflowsTechnical Writing - Provide technical input for validation deliverables, investigations, and develop/enhance procedures in accordance with established quality programsTraining - Provide training to system users and other admins; Assist with developing training program and proceduresConducts all activities in a safe and efficient mannerPerforms other duties as assigned Must be eligible to work in the US without immediate OR possible future sponsorship.
The Ideal Candidate would possess:
Strong computer, scientific, and organizational skillsExcellent communication (oral and written) and attention to detailAbility to work independently and as part of a team, self-motivation, adaptability, and a positive attitudeAbility to learn new techniques, perform multiple tasks simultaneously, keep accurate records, follow instructions, and comply with company policiesExperience in the analysis of therapeutic proteins using various HPLC Techniques including IEX, SEC, HIC and RP and CE including ICE and CE.Excellent oral and written communication skillsThe candidate must have effective documentation skills with the ability to author internal technical reportsExperience with Microsoft Word and Excel is requiredMinimum Qualifications:
Bachelor's in physical science (chemistry, engineering, computer science, etc.). Additional years of directly-related experience may be considered in lieu of degree (two years of directly related industry experience is equivalent to one full-time year of college in related major) Working schedule will be Full-Time, First Shift, Monday-Friday 8am-4pm. Candidates currently living within a commutable distance of Lancaster, PA are encouraged to apply. 25% travel may be required. This position is NOT remote.
What we Offer:
Excellent full time benefits including comprehensive medical coverage, dental, and vision optionsLife and disability insurance401(k) with company matchPaid vacation and holidaysEurofins USA BioPharma Services is a Disabled and Veteran Equal Employment Opportunity employer.