Compliance Engineering

Permanent employee, Full-time · Shannon

Your mission
A Compliance Engineer in the field of engineering plays a critical role in ensuring that products, systems, or processes adhere to relevant regulations, standards, and specifications. Their primary responsibility is to make sure that the engineering team work meets legal and industry-specific compliance requirements.
Job Description

Major Activities

  • Regulatory Compliance: Ensure that all engineering documents, projects, products, and processes adhere to relevant local, national, and international regulations, standards, and guidelines. This includes safety, environmental, quality, and industry-specific standards. 
  • Documentation: Maintain thorough and accurate records of engineering activities, including test reports, certifications, and audit findings. Prepare and review engineering documentation related to product quality and compliance including GMP standard operating procedures. This documentation helps demonstrate adherence to standards and regulations. 
  • Risk Assessment: Identify potential risks and compliance issues in engineering projects and work proactively to address them. This may involve conducting risk assessments and implementing corrective actions.
  • Audits and Inspections: Prepare for and participate in internal and external audits, ensuring that the engineering work is in compliance with the applicable standards. Address non-compliance issues and track corrective actions. 
  • Quality Control: Develop and implement quality control processes to monitor engineering activities, products, and systems to meet specified requirements. Conduct investigations and write reports for issues/deviations within the dept. Ensure CAPA actions for the dept are completed in a timely manner
  • Collaboration: Work closely with the engineering teams, and other departments to ensure compliance with established standards. Participate in daily and weekly departmental and interdepartmental meetings and value streams.
  • Testing and Validation: Plan and conduct tests and validation processes to verify that engineering designs and products meet the required standards and regulations. 
  • Continuous Improvement: Stay up-to-date with changes in regulations and standards and proactively implement improvements in engineering processes and products to maintain compliance. 
  • Training and Education: Train and educate engineering teams and other relevant personnel about compliance requirements and best practices. 
  • Reporting: Provide regular reports to management and relevant stakeholders on compliance status, audit findings, and areas that may need improvement. 
Key Performance Indicators
  • Proven track record in engineering in a compliance or similar role.
  • Collaborate  with various stakeholders  Describe Expectations
 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.
  • Innovation - displays original thinking and creativity; meets challenges with resourcefulness; generates suggestions for improving work; develops innovative approaches and ideas.
  • 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. 
  • Problem Solving - Identifies and resolves problems in a timely manner; gathers and analyzes information skillfully; develops alternative solutions; works well in group problem solving situations; uses reason even when dealing with emotional topics.
Job Responsibilities       
No Direct reports 
 
  • 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.

 Job Background
  • Bachelor's or higher degree in engineering or a related field.
  • Knowledge of relevant regulatory and industry-specific standards and requirements. 
  • Strong analytical and problem-solving skills.
  • Attention to detail and a strong commitment to quality.
  • Excellent communication and interpersonal skills. 
  • Project management and organizational abilities.
  • Familiarity with Computerised maintenance management systems is a plus (Maximo).
  • Familiarity with quality management systems (Mastercontrol) is a plus.
  • Experience in a similar role is preferred.
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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