LanceSoft, Inc. ยท 2 days ago
Process Validation Engineer
Harmans, MD
Contract
Onsite
Mid Level
3+ years expLanceSoft, Inc. is seeking an experienced Process Validation Engineer to support manufacturing and quality operations at their Harmans, MD facility. The ideal candidate will engage in process validation lifecycle activities and ensure compliance with FDA and internal quality standards through batch record review and validation documentation oversight.
Information Technology
Hiring Manager
Sai Madhav
Responsibilities
Support process validation lifecycle activities including protocol development, execution, data review, and final reports (PPQ, continued process verification)
Perform GMP batch record review (manufacturing and packaging) to ensure accuracy, completeness, and compliance with FDA and internal quality standards
Review validation documentation to confirm alignment with approved processes, critical process parameters (CPPs), and critical quality attributes (CQAs)
Identify documentation discrepancies, deviations, or gaps and work cross-functionally to drive timely resolution
Support deviation investigations, root cause analysis (RCA), and impact assessments related to validation and batch documentation
Assist with CAPA initiation, tracking, and effectiveness checks
Collaborate with Manufacturing, Operations, Technical Services, and Quality teams to ensure validation and documentation readiness
Ensure compliance with cGMP, GDP, FDA regulations, and internal SOPs
Support audit readiness activities, including internal and external audits as required
Qualification
Required
Bachelor's degree in Engineering, Life Sciences, or a related technical discipline
3+ years of experience in Quality Assurance, Process Validation, or Manufacturing QA within pharma, biotech, or regulated manufacturing environments
Strong hands-on experience with batch manufacturing record review
Solid understanding of process validation principles and GMP documentation practices
Experience with deviations, change control, and CAPA systems
Familiarity with quality systems and document management tools (e.g., TrackWise or similar)
Strong attention to detail and documentation skills
Ability to work onsite in Harmans, MD for the contract duration
Company
LanceSoft, Inc.
Established in 2000, LanceSoft is a pioneer in delivering top-notch Global Workforce Solutions and IT Services to a diverse clientele.
5001-10000 employees
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 StageLeadership Team
Ram Karuppusamy
Chairman & CEO
Simon Dealy
Chief Financial Officer
Company data provided by crunchbase