QC Validation Engineer / CSV Engineer- with pharma or biotech exp

Job Description

Job Description

JOB DESCRIPTION:- QC Validation Engineer

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/PAs)
- 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

Company Description

Founded in 2015 and backed by two decades of hands-on experience, our strong insight on the enterprise ecosystem and its dynamics helps to offer a complete end-to-end solution. We automate recruitment processes with intelligent solutions to save time and money. Synkriom leads the industry with experience authentication of candidates.

Company Description

Founded in 2015 and backed by two decades of hands-on experience, our strong insight on the enterprise ecosystem and its dynamics helps to offer a complete end-to-end solution. We automate recruitment processes with intelligent solutions to save time and money. Synkriom leads the industry with experience authentication of candidates.