Validation Engineer Dublin 22

Validation Engineer required for a New State of the Art Plasma Fractionation Protein Purification Plant in Grange Castle.

The Role

Validation Engineer demonstrates consistent application of technical knowledge. Executes assignments of medium complexity, developing solutions for defined problems.

Performs and oversees the validation of facilities, equipment, and processes. Reviews specifications, drawings, inspects installations, checks system operations, conducts and coordinates performance testing, and writes, reviews and approves validation documents (protocols, reports, etc.).

Approves standard operating procedures for routine validation activities. Is involved in validation monitoring activities which include audits with the system owner, review of operational documents. Assists with activities and provides guidance to contract specialists when needed.

Responsibilities

· Participates during all phases of validation: evaluates projects, provides guidance and technical information to others.

· Supports Installation Qualification activities in Engineering, checks operating parameters during Operational Qualifications, and coordinates with testing participants (Quality, Production) during Performance Qualifications, Performance Validation and Computer Validation activities.

· Reviews engineering drawings (Pipe & Instrument Designs, construction, as-built, flow diagrams) for compliance to Good Manufacturing Practices/Validation principles.

· Performs and reviews validation testing as required.

· Develops alternative solutions to problems, handles medium complexity problems independently. Demonstrates technical knowledge and ability to adapt to changing circumstances.

· Displays flexibility with assignments in different units. Demonstrates ability to influence others effectively.

· Makes decisions with designated assignments that influence the goals of the department.

· Produces anticipated results that contribute to business or technical goals.

· Works with outside contractors, Engineers, Laboratories and Quality.

· Writes, reviews and approves validation documents for selected projects, manages and maintains schedule of validation activities.

· Ensures documents are signed off in a timely manner.

· Coordinates activities with laboratories, provides team leadership and assumes responsibility for entire project management.

· Establishes priorities, equipment, and schedule activities.

· Reviews validation packets for completeness and accuracy, sound rationale, compliance with validation policies and procedures, and accurate data analysis.

· Compares results against acceptance criteria and brings exceptions and deviations to management's attention.

· Gives recommendations to management as to the acceptance and release of qualified systems

Requirements and Skills

4+ years working experience

Requires a BS/BA degree in Engineering or a scientific discipline.

Previous Pharmaceutical/Bioscience/Medical Device experience. Knowledge of aseptic processing and filling, sterilization, GMP regulations and Quality operations an added advantage.

Excellent oral and written communication skills.

Strong critical thinking and problem-solving skills. Ability to identify errors and provide corrective action.



For more information please contact Ann Marie Corcoran