Engineering Validation Intern

Intern / Student, Full-time · London

Your mission

Purpose of Job

To support the qualification activities of various equipment and systems for the Manufacturing, Quality Control (QC) and Engineering departments, within a state of the art gene therapy manufacturing facility.
Job Description

Major Activities

  • To assist in writing and reviewing of Validation protocols, as well as coordinating post execution reviews and approvals.
  • To assist in the execution of Validation protocols, performed by internal or external resources.
  • To support system owners with system/equipment User Requirement Specification (URS) and DQ (Design Qualification) documents and using a risk-based approach to determine the appropriate validation requirements.
  • 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 e.g. (but not limited to) Issues, CAPAs, Change Controls, BMRs & audit/inspection actions is closed timely and in a Right First Time (RFT) state.
Key Job Competencies

  • Oral Communication - speaks clearly and persuasively in positive or negative situations; listens and gets clarification; responds well to questions; demonstrates good presentation skills; participates effectively in meetings.
  • Written Communication - writes clearly and informatively; edits work for spelling and grammar; varies writing style to meet needs; presents numerical data effectively; able to read and interpret written information.
  • Planning/Organizing - prioritizes and plans work activities; uses time efficiently; plans for additional resources.
  • 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.
Job Background

  • Degree or equivalent, preferably with a higher qualification in a discipline related to Engineering and/or Bio-pharmaceutical Sciences.
  • Excellent collaboration skills.
  • Excellent verbal and written communication skills, in English.
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!
Thank you for your interest in MeiraGTx. Please fill out the following short form. Should you have difficulties with the upload of your data, please send an email to talent@meiragtx.com
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