Validation Engineer

Validation Engineer
Job Number: 26-01028

Be part of a company that delivers life-changing healthcare solutions. ECLARO is looking for a Validation Engineer for our client in Devens, MA.

ECLARO's client is a leader in the Biopharmaceutical Industry, providing quality, innovative, and affordable medicines that make a difference in the lives of patients all over the world. If you're up to the challenge, then take a chance at this rewarding opportunity!

Responsibilities:

• 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.

Required Qualifications:

• Required Bachelor's degree or Master's degree in Engineering, Chemistry, Biology, or in a related, scientific / computer-based field.
• 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.
• 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.

Preferred Skills:

• Minimum of 2 - 4+ years' experience in the biopharmaceutical industry or equivalent combination of education and validation / lab experience.
• Microsoft Office Applications.
• Computer system validation experience.
• Equipment validation experience.

Pay Rate: $52.14 - $55.30 / Hour

If hired, you will enjoy the following ECLARO Benefits:

• 401k Retirement Savings Plan administered by Merrill Lynch
• Commuter Check Pretax Commuter Benefits
• Eligibility to purchase Medical, Dental & Vision Insurance through ECLARO

If interested, you may contact:
June Binuya
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June Binuya | LinkedIn

Equal Opportunity Employer: ECLARO values diversity and does not discriminate based on Race, Color, Religion, Sex, Sexual Orientation, National Origin, Age, Genetic Information, Disability, Protected Veteran Status, or any other legally protected group status, in compliance with all applicable laws.