LanceSoft, Inc. · 3 weeks ago
Validation Engineer II
LanceSoft, Inc. is a company seeking a Validation Engineer II to contribute as an individual in identifying and implementing industry best practices. The role involves risk assessing systems, reviewing change requests and test scripts, and ensuring compliance with regulatory requirements and industry standards.
Information Technology
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 assessing systems, reviewing change requests and test scripts, drafting protocols and initiating and reviewing 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 process’ – Change Control (particularly associated with DCS ( DeltaV) and MES ( Syncade) systems, Deviations, CAPAs
Perform other duties as assigned
Qualification
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
Company
LanceSoft, Inc.
Established in 2000, LanceSoft is a pioneer in delivering top-notch Global Workforce Solutions and IT Services to a diverse clientele.
H1B Sponsorship
LanceSoft, Inc. 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 (55)
2024 (32)
2023 (23)
2022 (25)
2021 (60)
2020 (80)
Funding
Current Stage
Late StageCompany data provided by crunchbase