This role offers the opportunity to contribute to QC laboratory instrument qualification and validation work that supports regulated operations. As a Validation Engineer, you will work across laboratory, quality, and digital stakeholders to help maintain compliant systems, support instrument lifecycle activities, and strengthen validation practices in a GMP environment.
Responsibilities- Manage the entire lifecycle of QC laboratory instruments from procurement to qualification to decommissioning, ensuring compliance with applicable policies and regulations.
- Design, execute, manage, and implement QC instrument and software qualification documents, including URS, DQ, validation plans, IOQ protocols, software test scripts, configuration specifications, risk assessments, and qualification summary reports.
- Author and execute computer system validation scripts using ALM or paper-based methods.
- Own change controls related to qualification of QC instruments and associated software.
- Update the asset management database for new assets, calibrations, and preventative maintenance.
- Author instrument operational SOPs as needed.
- Coordinate, interface with, and host vendors on site.
- Champion qualification deviations and software defects, identifying root causes and CAPAs.
- Act as the liaison between Digital Plant (IT) and lab departments.
- Execute periodic assessments and decommissioning as needed.
RequirementsMust Haves- Bachelor's degree required
- Incumbents must have demonstrated experience in solving complex technical issues and have the skills and understanding to troubleshoot process defects
- Must have GMP experience
Qualifications and Experience Required- Required Bachelor's degree or Master's degree in Engineering, Chemistry, Biology, or in a related, scientific/computer-based field.
- Minimum of 2+ years' experience in the biopharmaceutical industry or equivalent combination of education and validation/lab experience will be considered.
- Experience with quality management systems including: document control/management, change controls, investigations, deviations, electronic validation databases, asset management database.
- Knowledge of cGMP regulatory requirements, computerized analytical systems, i.e., 21 CFR Part 11, GAMP, electronic record/electronic signature, data integrity, disaster recovery.
- Incumbents must have demonstrated experience in solving complex technical issues and have the skills and understanding to troubleshoot process defects.
- Microsoft Office Applications.
- Experience with computer system validation is preferred.
- Equipment validation experience is a plus.
- Eligible to work in the United States.
Benefits- Health insurance;
- Holiday pay;
- 401(k) program;
- Employee referral bonus program.
