Validation Consultant - OQSIE

Position Summary:

Qualification Engineer will lead activities which includes, but not limited to:

· Development, execute, review, approval and as applicable, execution of engineering and qualification tests/documentation such as commissioning, IQ, OQ, PQ, SAT, FAT, DOE, retrospective qualifications, Periodic qualification assessments etc.

· Will assist or lead the development of other documentation such as new equipment design, and documentation, PID’s, “as-built” drawings, user specifications, functional specifications, design and purchase specifications, change control, investigations, CAPA, Work Orders, and Document approvals.

Essential Areas of responsibility:

· Develop Qualification master plans, process flow diagrams, test cases, and standard operating procedures.

· Develop qualification documents, Functional and Design Specifications, Test Protocols (IQ/OQ/PQ), and Summary Reports, supplementing documentation provided by Suppliers/Contractors/OEMs.

· Preparing specific User Requirements Specification (URS).

· Performing Design Verification (Design Qualification) execution according to agreed format.

· Active participation in FAT, SAT, IQ and OQ activities and preparing related reports.

· Develop strong working relationships with the internal and external stakeholders and work well within a collaborative team environment

· Execution of Test Protocols, including identification and resolution of non-conformances/deviations.

· Conduct qualification tests of new or existing equipment, or software in accordance with internal protocols or external standards.

· Resolve testing problems by modifying testing methods or revising test objectives and standards.

· Tracking and managing change control activities as related to project.

· Reviewing functional, design and testing documentation from Suppliers/Contractors to ensure compliance to cGMP and Good Documentation Practices.

· Analyze data to perform assessment of current qualification state of equipment/facilities.

· Implement Risk management and criticality assessment techniques to highlight critical equipment, identify failure modes (FMEA) and implement strong controls for risk mitigation.

· Implement RCA/problem solving techniques for complex problems during project lifecycle.

· Identify deviations from established product or process standards and provide recommendations for resolving deviations.

· Prepare, maintain, or review engineering compliance documentation, such as engineering change orders, schematics, or protocols.

· Assist in training equipment operators or other staff on qualification protocols and standard operating procedures.

· Create, populate, or maintain databases for tracking qualification activities, test results, or validated systems.

· Prepare detailed reports or design statements, based on results of qualification tests or reviews of procedures and protocols.

· Communicate with regulatory agencies regarding compliance documentation or qualification results.

· Deploy Project Management tools for qualification activities to ensure completion of all activities as per baseline schedule (using MS Project, Primavera etc.)

Qualifications Required

· For Qualification Engineers:

o Experience: 8+ Years’ experience - at least 4 years working experience in commissioning, qualification and/or validation activities. Experience in Sterile Operation is a plus.

o Industry: Pharmaceutical, Biopharmaceuticals, cGMP manufacturing environment, or equivalent

o Background: Engineering, Projects, Qualification or Validation, Ops., Quality Assurance.

o Education: BS/BA degree in science, engineering, manufacturing technology or closely related field.

· Understanding of Project Lifecycle from conceptual design phase through startup, commissioning and qualification

· Knowledge of relevant regulatory requirements (E2500 standard, ISPE Guidelines for Qualification/Validation)

· Ability to read and understand P&ID’s, PFD’s

· Excellent organizational and communication/people skills

· Problem analysis and problem solving

· Strong verbal and written skills

· Evaluate audit findings and implement appropriate corrective actions

· Strong computer skills including Microsoft Office, QA applications and databases

· Self-motivated and able to work with minimum supervision Preferred

· Project Management experience and PMP certificatio