Validation Engineer, Sterile
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At a glance
Job overview
The Validation Engineer, Sterile supports validation and qualification of manufacturing and packaging equipment, facilities, utilities, and systems within a sterile GMP environment, preparing and executing protocols, coordinating with cross‑functional teams, and maintaining documentation to meet cGMP and regulatory standards.
Skills & qualifications
Skills
Full job description
Description:
The Validation Engineer, Sterile, supports validation and qualification activities for manufacturing and packaging equipment, facilities, utilities, and systems in a sterile GMP environment. Prepares and executes FAT/SAT, IQ/OQ, PQ, and requalification protocols and reports, ensuring documentation meets specifications, cGMP standards, and site procedures. Coordinates activities with Engineering, Manufacturing, Quality, vendors, and contractors; documents deviations; and supports timely resolution, change control, CAPA, and continuous improvement.
Essential Functions:
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Prepares and revises validation plans, protocols, reports, traceability matrices, risk assessments, and supporting documents for assigned equipment and systems. Reviews Design Qualification (DQ) documents and related design and vendor documentation for completeness and alignment with user requirements, cGMP expectations, and site procedures. Tracks assigned deliverables and communicates schedule, risks, and documentation needs to project stakeholders.
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Executes and documents factory acceptance testing (FAT), site acceptance testing (SAT), installation qualification (IQ), operational qualification (OQ), performance qualification (PQ), and requalification for manufacturing and packaging equipment, facilities, and utilities. Verifies test data and acceptance criteria, identifies discrepancies, initiates protocol deviations, and supports their investigation and resolution. Assists with the validation master plan, requalification program, and environmental monitoring performance qualification (EMPQ), as assigned.
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Supports commissioning, equipment installation, startup, and turnover to operations. Coordinates test execution with Engineering, Manufacturing, Quality, vendors, and contractors. Maintains validation schedules and document status; reviews drawings, specifications, calibration records, and turnover packages; and supports development of validation-related SOPs and training materials.
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Drafts and revises SOPs and work instructions. Initiates or supports change controls and validation impact assessments. Participates in investigations, root-cause analysis, data review, deviation resolution, and implementation and effectiveness verification of CAPAs related to validated systems.
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Maintains accurate, complete, and traceable validation records in accordance with cGMP, good documentation practices (GDP), data-integrity principles, approved procedures, and applicable regulatory requirements. Supports audits and inspections by retrieving records and explaining assigned validation activities.
Additional Responsibilities:
- Maintains validation documents, equipment files, tracking logs, and requalification schedules in an inspection-ready state.Reviews user requirements, P&IDs, drawings, specifications, vendor manuals, calibration records, and maintenance records to support qualification activities.Coordinates field execution and confirms that approved protocols, trained personnel, calibrated instruments, materials, and system prerequisites are available.
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