Validation Engineer

Validation Engineer

Permanent employee, Full-time · Shannon

This is a key role in the site commissioning phase at our client’s Manufacturing Facility In Ireland for the manufacture of Advanced Therapies (Gene Therapy viral vectors). The facility will manufacture plasmid and clinical material with the ambition of producing commercial supply in. The facility requires an Validation Engineer to assist the Head of Engineering with the implementation and operation of the site commissioning plan.

This is a fast track program, therefore the role requires the ability to be flexible and covers a very broad remit.

Experience / Professional Background

• BSc/MSc or BEng/MEng in Engineering or related discipline.
• 5 -7 years minimum in validation, quality systems, operations, engineering or any combination thereof.
• Experience in multiple GMP validation disciplines (process equipment, utility, automation, computer systems, sterilization) with advanced technical knowledge.
• Validation experience using risk based approach guidelines, international regulatory requirements and standards and other in.
• Experience interacting with or creating material for representatives of regulatory agencies and executive level staff.
• Experience with investigations into manufacturing deviations and determination of product impact potential, root cause and corrective actions.

Major Activities

• Effectively working within a multidisciplinary team to Prepare, schedule and execute Commissioning, Qualification and Validation protocols.
• Lead Risk assessments for process and equipment as required.
• Develop system impact assessments, validation plans, protocols and reports that support the qualification and validation of systems.
• Execute Commissioning and validation of manufacturing equipment, downstream equipment and processes in addition to supervising and witnessing Validation / Qualification carried out by vendors.
• Develop protocols for validation projects using a risk based approach that meets regulatory requirements and industry practices.
• Review and approve Layout development and review for material and personnel flow compliance.
• Review analyze and interpret system performance data for completed validation and prepare final report packages by summarizing the data.
• Investigate deviations, write investigation reports and create summary reports.
• Manage equipment vendors to get vendor qualifications scheduled and executed.
• Promote cGMP and regulatory compliance into assigned projects.
• Exercise good judgment within generally defined practices and policies in selecting methods and techniques for obtaining solutions.
• Strong trouble shooting and Safety compliance experience is essential for this role.
• Responsible for ensuring that own work complies with GMP, Data Integrity and Good Documentation Practice (GDP) and is undertaken in accordance with applicable procedures.
• Responsible for ensuring that own training is undertaken in a timely and GMP compliant manner before the task is undertaken.
• Responsible for ensuring that any GMP documentation assigned to me e.g. (but not limited to) Issues, CAPAs, Change Controls, BMRs & audit/inspection actions are closed timely and in a RFT state.

Key Job Competencies 

• Comprehensive practical and theoretical understanding of a wide range of industrial plant and cleanroom services and utility equipment.
• Proven experience in commissioning plant and equipment in a GMP environment
• Problem Solving - Identifies and resolves problems in a timely manner; gathers and analyses information skillfully; develops alternative solutions; works well in group problem solving situations; uses reason even when dealing with emotional topics.
• Leadership - exhibits confidence in self and others; inspires and motivates others to perform well; effectively influences actions and opinions of others; accepts feedback from others; gives appropriate recognition to others.
• Motivation - sets and achieves challenging goals; demonstrates persistence and overcomes obstacles; measures self against standard of excellence; 
• Planning/Organizing - prioritizes and plans work activities; uses time efficiently; plans for additional resources; sets goals and objectives; organizes or schedules other people and their tasks; develops realistic action plans.
• Professionalism - approaches others in a tactful manner; reacts well under pressure; treats others with respect and consideration regardless of their status or position; accepts responsibility for own actions; follows through on commitments.
• Quality Management - looks for ways to improve and promote quality; demonstrates accuracy and thoroughness.
• Innovation - displays original thinking and creativity; meets challenges with resourcefulness; generates suggestions for improving work; develops innovative approaches and ideas.
• Communication - verbally communicates clearly and persuasively; listens and seeks clarification when needed; good presentation skills; participates effectively in meetings. Writes clearly and informatively; varies writing style to meet needs; presents numerical data effectively; able to read and decipher written information.

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