PharmEng Technology · 21 hours ago
Validation Engineer
Houston, TX
Full-time
Onsite
Mid LevelPharmEng Technology is seeking a detail-oriented and experienced Validation Engineer to support pharmaceutical manufacturing validation projects. The role focuses on the execution, review, and documentation of Installation and Operational Qualification (IOQ), Performance Qualification (PQ), and related validation activities for critical systems and equipment.
ConsultingInformation TechnologyPharmaceutical
Responsibilities
Draft, execute, review, and document Installation and Operational Qualification (IOQ) protocols, addendums, and summary reports for various pharmaceutical manufacturing equipment and systems (e.g., TOC Analyzer, Purified Water System, Autoclave, Steam Generator, Clean Room, etc.)
Prepare and manage User Requirement Specifications (URS), Site Installation Assessments (SIA), and Configuration Specifications
Lead system-related deliverables including validation protocols, addendums, test scripts (e.g., Pi tests), and summary reporting
Support the completion of Site Acceptance Testing (SAT) and vendor protocol review and approval for equipment qualifications
Manage validation documentation closure activities including Nonconformance (NEC) closure, Change Control Request (CCR) closure, and Deviation Investigation and Root Cause Analysis (DIRA)
Collaborate with cross-functional teams to ensure compliance with CGMP and regulatory standards throughout the validation lifecycle
Revise and update validation master plans, Validation Project Plans (VPP), and User Requirement Specifications (URS) as necessary
Facilitate technical reviews such as Operational Maintenance Check (OMC) reviews and support technical audits
Maintain meticulous documentation and ensure timely delivery of all validation reports and associated documents
Qualification
Required
Bachelor's degree in Engineering, Pharmaceutical Sciences, or related technical field
Proven experience in pharmaceutical manufacturing validation, including hands-on execution of IQ/OQ/PQ protocols
Strong understanding of CGMP, FDA, EMA regulations, and GMP validation requirements
Knowledge of utilities, critical manufacturing systems, and laboratory instruments (e.g., TOC analyzers, purified water systems, autoclaves)
Experience with technical documentation, deviation handling, and change control processes
Excellent organizational skills and attention to detail in documentation and report generation
Ability to work independently and as part of a project team under contract terms
Preferred
Experience with ERES and DIRA as part of deviation investigations
Familiarity with configuration specifications and validation lifecycle management tools
Strong communication skills and the ability to collaborate effectively with quality, manufacturing, and engineering teams
Company
PharmEng Technology
PharmEng Technology is a pharmaceutical company that provides consultancy services.
Founded in 1997
201-500 employees
H1B Sponsorship
PharmEng Technology 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
2024 (3)
2023 (1)
2022 (1)
Funding
Current Stage
Growth StageLeadership Team
Alan Kwong
Managing Director & CEO
Company data provided by crunchbase