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Mindlance · 1 month ago

Validation Engineer II

Portsmouth, NH

Full-time

Onsite

Mid Level

Mindlance is a company focused on providing innovative solutions in the engineering sector. They are seeking a Validation Engineer II to identify and implement industry best practices while ensuring compliance with regulatory requirements and industry standards.

Human Resources

H1B Sponsor Likely

Responsibilities

Identify and implement industry best practices through an extensive industry network and detailed knowledge of applicable regulations

Work with other experienced members of the CSV team to identify roadblocks and additional efficiencies during the scoping portion of improvement projects

Risk assess systems, review change requests and test scripts, draft protocols and initiate and review GMP documentation revisions

Execute all responsibilities as the CSV owner for significant site and process improvement projects to ensure compliance to appropriate regulatory requirements and industry standards while maximizing efficiency

Perform all aspects of QMS processes – Change Control (particularly associated with DCS (DeltaV) and MES (Syncade) systems), Deviations, CAPAs

Perform other duties as assigned

Qualification

Equipment validationComputer validationControls AutomationProcess Control SystemsManufacturing Execution SystemsBiotech industry experienceDeadline managementAttention to detailIndependent work

Required

Substantial experience in equipment and/or computer validations

Working experience with Controls Automation, Process Control Systems, Distributed Systems, Manufacturing Execution Systems (MES) required

Prior experience leading projects in a Biotech/Pharma or biologics industry

Strong attention to detail and ability to work independently and meet deadlines successfully

Preferred

DeltaV preferred

Company

Mindlance

Glassdoor4.1

Mindlance is a Staffing and Recruiting company which provides multi-vertical staffing services

Founded in 1999

Union, New Jersey, USA

1001-5000 employees

http://www.mindlance.com

H1B Sponsorship

Mindlance has a track record of offering H1B sponsorships. Please note that this does not guarantee sponsorship for this specific role. Below presents additional info for your reference. (Data Powered by US Department of Labor)

Distribution of Different Job Fields Receiving Sponsorship

Represents job field similar to this job

Trends of Total Sponsorships

2025 (71)

2024 (53)

2023 (37)

2022 (72)

2021 (36)

2020 (40)

Funding

Current Stage

Late Stage

Leadership Team

Rajat Paul Dhall

Co-Founder & Managing Director

Vik Kalra

Co-Founder and Managing Director

Recent News

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Company data provided by crunchbase