Shoolin Inc · 1 day ago
Validation Engineer
North Carolina, United States
Contract
Onsite
Mid, Senior Level
3+ years expShoolin Inc is seeking a Sr. Validation Engineer to support process validation and equipment qualification activities across regulated manufacturing environments. This role involves executing validation studies, authoring protocols, supporting sampling activities, and ensuring compliance with applicable regulatory guidelines.
Artificial Intelligence (AI)Big DataCloud ComputingInformation TechnologyInternet of ThingsSoftware
Hiring Manager
Aadil Shaikh
Responsibilities
Develop and execute validation strategies aligned with regulatory expectations
Lead or support process validation and PPQ protocol development and execution
Perform commissioning and qualification for equipment and facility systems
Conduct risk and gap assessments and support lifecycle management reviews
Maintain equipment master data and audit-ready documentation
Support SOP, protocol, and report development
Execute validation studies on the manufacturing floor and support sampling activities
Collaborate with cross-functional teams (Manufacturing, QA, QC, PD)
Qualification
Required
3+ years in validation or process engineering within Pharma/Biotech
Strong experience in process validation and PPQ
Hands-on equipment qualification/C&Q (equipment, utilities, facility systems)
Experience authoring and executing IQ/OQ/PQ protocols
Knowledge of FDA/EMA cGMP and ICH Q7–Q10 (or equivalent regulatory standards)
Experience with FMEA, risk-based validation, and change control
Hands-on sampling, aseptic techniques, and routine lab activities
Experience working with MES, automation systems, and LIMS
Company
Shoolin Inc
Shoolin-Inc staffing, specializes in providing world class recruiting services to companies in the Healthcare, IT, and Engineering sectors.
51-200 employees
H1B Sponsorship
Shoolin 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 (81)
2024 (45)
2023 (48)
2022 (36)
2021 (29)
2020 (18)
Funding
Current Stage
Growth StageCompany data provided by crunchbase