Validation Engineer

1 hour ago

Houston, Texas, United States PharmEng Technology Full time


Validation Engineer  (Pharmaceutical Manufacturing)

Location: Houston, TX

Job Summary:

We are 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 including TOC analyzers, purified water systems, autoclaves, steam generators, clean rooms, and utilities.

Key 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.
Deliverables Include (but are not limited to):
  • IOQ drafts, execution, reviews, addendums, and summary reports for multiple systems including TOC Analyzer, Purified Water System, Autoclave, Steam Generator, Clean Room, UDAF, and Clean Steam systems.
  • Drafting and execution of Performance Qualification (PQ) protocols and reports as applicable.
  • Configuration specifications, URS revisions, ERES and DIRA investigations.
  • Vendor IOQ pre-approval, execution, and documentation.
  • NEC and CCR closure for all assigned validation projects.
Qualifications:
  • 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 Skills:
  • 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.

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