Engineering Validation Specialist

Purpose of Job

• Provide ongoing engineering validation support pertaining to the validation requirements for all GxP processes, equipment, facilities, and computerised system across MeiraGTx sites.
• Remain up to date and act as a subject matter expert in relation to applicable EU and FDA regulations, ensuring that MeiraGTx validation policies and procedures remain compliant and best practice.
• Ensure that all validation documentation is subject to engineering validation review in a timely manner and in line with regulatory and business requirements.
• Support QMS activities such as review of deviation investigations and impact assessment of change controls, where validation and computerised systems expertise is required.

Major Activities and Responsibilities

• Adequately provide support and oversight to activities related to validation, and computerised systems, activities, ensuring compliance with EU, UK and FDA GxP regulatory requirements, MeiraGTx QMS and any other applicable regulations/standards.
• Maintaining an understanding of cGMP, GEP (Good Engineering Practice), computerised systems validation, and guidance in relation to all aspects of validation across manufacturing, laboratories and facilities.
• Ensure the timely review of qualification protocols, discrepancies, and associated reports in a timely manner reporting any concerns to Engineering Management.
• Act as reviewer/ approver for MeiraGTx Policies, and SOPs, that govern the MeiraGTx validation and computerised systems requirements.
• Interface with other departments such as QA, Facilities, Laboratories, Operations, Warehouse, IT, and Process Development to ensure that validation project plans are understood and in keeping with site objectives.
• Represents the company as an SME for Validation compliance during regulatory inspections and partner audits, inclusive of support for the compilation of any required responses and other follow-up activities.
• Lead problem solving and remediation requirements for operational compliance systems.
• Ensure area of responsibility is inspection ready and kept in compliance.
• Responsible for ensuring that any GMP documentation e.g. (but not limited to) Issues, CAPAs, Change Controls & audit/inspection actions, within own area of responsibility, are closed within date and in a ‘Right First Time’ state.
• Ensure own training is undertaken in a timely and compliant manner before any associated tasks are undertaken.
• Ensure that own work complies with GMP, Data Integrity & Good Documentation Practice (GDocP) and is undertaken in accordance with MeiraGTx’s QMS.

Key Performance Indicators

• In conjunction with the Validation function ensuring that company validation procedures are ‘fit for purpose’ and in line with regulatory requirements.
• Ensure that all GxP equipment and facilities are appropriately qualified, and that they are maintained in such a state throughout their lifecycle, informing Engineering Management of any concerns in a timely manner.
• · Own responsibilities are performed in a timely manner, escalating any and all issues to Engineering Validation Manager as and when they occur.Describe Expectations

Key Job Competencies

• Experience in communicating with regulators during health authority inspections is desirable.
• Can identify and escalate issues to line management, to ensure workload is prioritised, issues are highlighted to ensure business needs are met.
• Approachable and professional manner, reacting well under pressure, accepting feedback and managing opinions of others.
• Effective written communicator, able to deliver concise documentation, adapting writing style to audience as appropriate.
• Ability to dissect problems and solutions to provide a variety of unique options in a comprehensive manner
• Effectively manage changes in accordance with change control processes.
• Ability to work in a fast-paced environment.
• · Logical, problem-solving manner, able to adapt to changeList key competencies to fulfil role

Job Responsibilities

• Educated to degree level in Human Health, Sciences or equivalent.
• Minimum 5 years’ experience working predominantly in Engineering Validation department with emphasis on Computer System Validation execution and Validation activities.
• Excellent practical Knowledge of GxP regulations and guidelines with regards to validation and qualification
• English language required.