Process Engineer

Permanent employee, Full-time · Shannon

Your mission
MeiraGTx has established a Manufacturing Facility for Advanced Therapies (Gene Therapy viral vectors) in Shannon, producing Clinical materials for its in-house programs. We are seeking a flexible and skilled Process/Project Engineer to support GMP manufacturing process operations as well as the associated facilities and utilities services. The role also supports Capex and tech transfer projects delivered in fast-track program setting.
Job Description

Major Activities

  • Manufacturing Support: Integration into the relevant business unit that supports manufacturing requirements in a highly regulated GMP environment for the manufacture of Advanced Therapeutic Medicinal Products (ATMPs).
  • Capital Projects: Support the design and review of capital projects, particularly for single-use biopharmaceutical manufacturing equipment.
  • Vendor Coordination: Coordinate vendor activities for commissioning, qualification, maintenance, calibration, and process improvements.
  • Technical Transfer: Support technical transfer activities, including design and developing specifications for single-use equipment items. Provide SME input to Process Failure Modes and Effects Analysis (FMEA).
  • Engineering Standards: Assist in implementing and developing applicable engineering specifications and standards as they relate to local and multi-site Operations.
  • Safety, Health, and Environment (SH&E): Provide SME input on SH&E programs, including risk assessments, safety investigations, and other safety improvement activities.
  • GMP and Documentation Compliance:
  • Ensure all work complies with GMP, Data Integrity, and Good Documentation Practice (GDP).
  • Complete tasks according to applicable procedures and ensure timely and compliant training.
  • Ensure timely and right-first-time (RFT) closure of GMP documentation, including issues, CAPAs, Change Controls, Batch Manufacturing Records (BMRs), and audit/inspection actions.
  • Continuous Improvement: Demonstrate a right-first-time ethos while ensuring compliance with statutory, regulatory, and company standards, procedures, and systems.
  • Waste Reduction and Energy Efficiency: Identify and implement technology-based and work practice solutions to reduce waste and overall cost.

Key Performance Indicators

  • Deliver sustainable improvements measured by KPIs aligned with safety and quality compliance policies.
  • Support project deliverables, ensuring on-time completion and adherence to quality standards.
  • Proactively contribute to the development and effectiveness of the engineering team.
  • Demonstrate experience working in a highly regulated cleanroom environment within the bioprocessing sector.

Key Job Competencies

  • Comprehensive practical and theoretical background in a wide range of biopharmaceutical equipment and manufacturing processes.
  • Familiarity with computerized equipment systems and data integrity principles.
  • Experience with commissioning and qualification of process equipment and utilities.
  • Strong problem-solving skills and the ability to resolve issues in a structured and timely manner.
  • Leadership qualities with the ability to inspire and motivate others.
  • High motivation with the ability to set and achieve challenging goals.
  • Excellent planning and organizing skills with efficient time management.
  • Professional demeanor with the ability to handle pressure and treat others with respect.
  • Innovative thinking and creativity to meet challenges resourcefully.
  • Effective communication skills, both verbal and written, with good presentation abilities.

Job Responsibilities

  • Compliance: Ensure conformance to Site Safety & Quality Management Systems requirements
  • Projects delivery: According to approved scope, schedule and cost provisions.
  • Manufacturing Support: Performance within the business unit to achieve SQSCT Goals & Targets.

Job Background

  • Qualified to Degree Level in a related Engineering or Science discipline.
  • Minimum 5 years’ experience in a biopharmaceutical environment in a process engineering role.
  • Essential cleanroom working knowledge.
  • Essential knowledge of biopharmaceutical process operations, including media and buffer preparation, upstream and downstream processing (e.g., single-use bioreactors, centrifuges, UF/DF, TFF).
  • Proficient in English (verbal and written).
  • Desirable experience of working in a start-up environment.
  • Desirable experience with fill-finish operations.
About us

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 including three ocular indications, a salivary gland condition, and a Parkinson’s disease program. Our initial focus on diseases of the eye, salivary gland and central nervous system is based on the significant unmet medical need coupled with the high potential gene therapy has to provide meaningful clinical benefit in these areas. With headquarters in New York and London, our global footprint provides us the opportunity to partner with leading institutions around the world, allowing us to deepen our understanding of diseases and their progression.

Our team was built with deep expertise in gene therapy development, allowing us to efficiently advance our programs from preclinical to clinical development. Our core capabilities in viral vector design and optimization and gene therapy manufacturing give us a differentiated approach to developing gene therapies. Additionally, we are developing proprietary technology to potentially enable innovative gene therapy treatments whose expression can be turned on and off with an easily administered small molecule. We believe temporal control of gene therapy products has the potential to transform the gene therapy landscape.

Our state-of-the-art manufacturing facility, completed in early 2018, was designed to meet global regulatory requirements, including the current good manufacturing practices (cGMP) required by the Medicines and Healthcare products Regulatory Agency (MHRA) in the UK and the U.S. Food and Drug Administration (FDA). The 29,000-square foot facility has the flexibility and capacity to produce sufficient product for all our clinical trials and will scale to commercial capacity.

We are looking forward to hearing from you!
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