Validation Engineer
Validation Engineer
Posted on :
31-07-2025
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1 Vacancy
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Job Description
Validation Engineer (Pharmaceutical Manufacturing)
Location: Houston TX
Contract Duration: 6 months
Job Summary:
We are seeking a detail-oriented and experienced Validation Engineer on a contract basis 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:
- Bachelors 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.
Employment Type
Full Time
Key Skills
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