Validation Engineer

SOKOL GxP Services•Devens, MA

10d

About The Position

SOKOL GxP Services is a life sciences services firm providing CQV, validation, and compliance support, along with specialized technical staffing for regulated GMP environments. Working across the pharmaceutical space, the team supports critical quality and validation activities that help organizations operate reliably and in compliance. 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.

Requirements

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
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.
Eligible to work in the United States.

Nice To Haves

Experience with computer system validation is preferred.
Equipment validation experience is a plus.

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.