Validation Engineer

Job Description: 100% onsite with some flexibility

Responsibilities will include (but not limited to):

• Manage the entire lifecycle of QC laboratory instruments from procurement to qualification to decommissioning, ensuring all activities are in compliance with applicable policies/regulations.
• Design, execute, manage, and implement QC instrument/software qualification documents such as (but not limited to): User Requirement Specification (URS), Design Qualification (DQ), validation plans, equipment IOQ protocols, software test scripts, configuration specifications, risk assessments, qualification summary reports.
• Author/execute computer system validation scripts using an electronic validation database (ALM), or paper-based.
• Own change controls specific to the qualification of QC instruments and its associated software.
• Update the asset management database to reflect new assets, calibrations, preventative maintenances.
• Author instrument operational SOPs as needed.
• Coordinate/interface/host vendors on site.
• Champions qualification deviations/software defects, identifying root causes and Corrective Actions/Preventive Actions (CA/Client).
• Acts as the liaison between Digital Plant (IT) and lab departments.
• Execute periodic assessments/decommissioning, as needed.

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 – 4+ years’ experience in the biopharmaceutical industry or equivalent combination of education and validation/lab experience will be considered.
• Quality management system experience 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.
• Demonstrated success in cross functional influencing, strong communication, and collaboration skills.
• Must have GMP experience.
• Microsoft Office Applications, preferred.
• Computer system validation experience, preferred.
• Equipment validation experience is a plus.