• Job Type:Contract

Posted 3 days ago

Job Description:

QC Lifecycle Validation Engineer
Devens, MA
Hybrid Role: 4 days onsite/1 day work from home (Manager will adjust schedule as the business/project needs are required.)

Responsibilities will include (but not limited to):

• Act as the project lead for qualification of QC equipment and its associated software

• 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 as required.

• 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.

Education, Qualifications and Experience Required:

• Bachelor’s degree in relevant scientific, engineering, or computer-based area with 5 – 7 years experience in the biopharmaceutical industry or equivalent combination of education and validation/CSV/lab experience.

• 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.

• Working knowledge of laboratory systems such as Empower, NuGenesis and other software programs, including

• Microsoft Office Applications, preferred.

• Must have equipment validation experience.

• Must have GMP experience.

• Must have Quality Management System (QMS) experience.

• Experience in Computer System Validation is a plus.

• Experience in any asset management software is a plus.

About ASK: ASK Consulting is an award-winning technology and professional services recruiting firm servicing Fortune 500 organizations nationally. With 5 nationwide offices, two global delivery centers, and employees in 42 states-ASK Consulting connects people with amazing opportunities.

ASK Consulting is an equal opportunity employer. We celebrate diversity and are committed to creating an inclusive environment for all associates.