Engineering Validation Specialist

MeiraGTx Limited; City of London; On-site; GBP 50,000 - 70,000; Full time

Job summary

A clinical-stage gene therapy company is seeking an Engineering Validation Specialist in London. This role involves overseeing validation activities, ensuring compliance with regulatory requirements, and a strong understanding of GxP guidelines. Candidates should have at least 5 years' experience in Engineering Validation and a relevant degree. This full-time position offers opportunities for professional growth within the biotechnology industry.

Qualifications

• 5 years' experience in an Engineering Validation role with emphasis on Computer System Validation.
• Excellent knowledge of GxP regulations and guidelines.
• English language proficiency required.

Responsibilities

• Support and oversee validation activities ensuring compliance.
• Maintain understanding of cGMP and validation guidelines.
• Review qualification protocols and escalate concerns.

Skills

Communication with regulators

Problem identification and escalation

Written communication

Change management

Ability to work in a fast-paced environment

Education

Degree in Human Health, Sciences or equivalent

Job description

Join to apply for the Engineering Validation Specialist role at MeiraGTx

Overview

MeiraGTx is a clinical-stage gene therapy company focused on developing potentially curative treatments for patients living with serious diseases. We currently have six programs in clinical development across ocular indications, a salivary gland condition, and a Parkinson’s disease program. Our headquarters are in New York and London, with a global footprint to partner with leading institutions worldwide.

Major Activities and Responsibilities

• Adequately provide support and oversight to validation activities and computerised systems, ensuring compliance with EU, UK and FDA GxP regulatory requirements, MeiraGTx QMS, and applicable standards.
• Maintain an understanding of cGMP, GEP (Good Engineering Practice), computerised systems validation, and guidance related to validation across manufacturing, laboratories and facilities.
• Ensure timely review of qualification protocols, discrepancies, and related reports, escalating concerns to Engineering Management as needed.
• Act as reviewer/approver for MeiraGTx Policies and SOPs governing validation and computerised systems requirements.
• Interface with QA, Facilities, Laboratories, Operations, Warehouse, IT, and Process Development to ensure validation project plans align with site objectives.
• Represent the company as an SME for Validation compliance during regulatory inspections and partner audits, including support for required responses.
• Lead problem solving and remediation for operational compliance systems.
• Ensure readiness and compliance of GMP documentation within own area of responsibility (e.g., Issues, CAPAs, Change Controls, audit/inspection actions) and timely closure.
• Ensure own training is completed in a timely and compliant manner prior to related tasks.
• Ensure work complies with GMP, Data Integrity & Good Documentation Practice (GDocP) in line with MeiraGTx’s QMS.

Key Performance Indicators

• Ensure validation procedures are fit for purpose and aligned with regulatory requirements.
• Confirm GxP equipment and facilities are appropriately qualified and maintained throughout their lifecycle, informing Engineering Management of concerns promptly.
• Perform responsibilities in a timely manner and escalate issues to the Engineering Validation Manager as needed.

Key Job Competencies

• Experience in communicating with regulators during health authority inspections is desirable.
• Ability to identify and escalate issues to line management to prioritize workload and meet business needs.
• Approachable and professional demeanor, able to handle pressure, accept feedback, and manage opinions of others.
• Effective written communicator, delivering concise documentation tailored to the audience.
• Ability to dissect problems and offer multiple viable options in a comprehensive manner.
• Effectively manage changes in accordance with change control processes.
• Ability to work in a fast-paced environment.

Job Requirements

• Degree in Human Health, Sciences or equivalent.
• Minimum 5 years’ experience in an Engineering Validation role with emphasis on Computer System Validation execution and validation activities.
• Excellent practical knowledge of GxP regulations and guidelines related to validation and qualification.
• English language required.

Employment Details

• Seniority level: Mid-Senior level
• Employment type: Full-time
• Job function: Quality Assurance
• Industries: Biotechnology

Referrals increase your chances of interviewing at MeiraGTx.