MaximaTek · 14 hours ago
Validation Engineer
Wyoming, United States
Full-time
Onsite
New Grad, Entry, Mid Level
0+ years expMaximaTek partners with top-tier companies in the life sciences and manufacturing sectors, specializing in Quality and Compliance. As a Validation Engineer, you will ensure that all computerized systems and manufacturing equipment meet internal standards and external regulatory requirements, driving the full validation lifecycle from risk assessment to the final handover of qualified systems.
Management Consulting
Hiring Manager
Sai Teja Kothapally
Responsibilities
Documentation: Author and execute Validation Plans, Protocols (IQ/OQ/PQ), and Final Summary Reports
System Lifecycle: Oversee the validation of automated systems, PLC-based equipment, and enterprise software
Risk Management: Conduct GxP assessments and functional risk assessments to identify critical-to-quality (CTQ) parameters
Compliance: Ensure all engineering activities adhere to ALCOA+ data integrity principles and current Good Manufacturing Practices (cGMP)
Cross-Functional Collaboration: Coordinate with QA, IT, and Production teams to manage Change Controls and resolve Deviations
Qualification
Required
Bachelor's or Master's degree in Biomedical Engineering, Chemical Engineering, Computer Science, or a related technical field
0–5 years of experience in a regulated industry (Pharma/MedTech) or academic project experience related to quality systems
Strong understanding of the V-Model and GAMP 5 frameworks
Proficiency in writing and executing IQ, OQ, and PQ
Knowledge of 21 CFR Part 11 (Electronic Records and Signatures)
Experience with Change Control and Deviation Management
Preferred
Familiarity with Laboratory Information Management Systems (LIMS) or MES
Knowledge of PLC/SCADA systems and automation validation
Experience with statistical tools (Minitab) and Root Cause Analysis (RCA)
Benefits
Targeted Placement: Direct marketing to our network of hiring managers in Life Sciences and MedTech.
Validation Resume Rebuild: Optimization of your resume to highlight GxP knowledge and technical documentation.
Interview Coaching: Guidance on navigating quality-focused interviews and regulatory case studies.
Company
MaximaTek
Maxima Technologies is a privately owned, leading professional IT services firm Based in Cheyenne, WY.
51-200 employees
Funding
Current Stage
Growth StageCompany data provided by crunchbase