Job description

QC Lifecycle Validation Engineer

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

Duration: 12+ months

Job Description:
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.

TechData is proud to be an equal opportunity workplace and is an affirmative action employer. We are committed to equal employment opportunity regardless of race, color, ancestry, religion, sex, national origin, sexual orientation, age, citizenship, marital status, disability, gender identity or Veteran status.

Job Types: Contract, Temporary

Pay: Up to $67.47 per hour

Benefits:

• Dental insurance
• Health insurance

Schedule:

• 8 hour shift
• Day shift
• Monday to Friday

Education:

• Bachelor's (Required)

Experience:

• document control/management, change controls: 1 year (Required)
• deviations, electronic validation databases: 1 year (Required)
• cGMP regulatory requirements: 1 year (Required)
• biopharmaceutical industry: 4 years (Required)
• validation/CSV/lab: 4 years (Required)

Work Location: Hybrid remote in Devens, MA 01434

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