About Your New Employer:
A clinical-stage genetic medicine start-up company with a broad pipeline of late-stage clinical programs supported by end-to-end manufacturing capabilities. The Employer offers the state-of-the-art production facilities as well as an in-house Quality Control hub for stability and release, all fit for IND through commercial supply.
They believe temporal control of genetic medicine products has the potential to transform the genetic medicine landscape.
About Your New Job as a Compliance Engineer:
- 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.
- Proven track record in engineering in a compliance or similar role
- 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.
What Skills You Need to succeed as a Compliance Engineer:
- Bachelor's or higher degree in engineering or a related field.
- Previous experience in Biotech/Pharmaceutical/Medical Devices industry is essential
- Proven track record in engineering in a compliance or similar role
- 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.
What’s on Offer for Candidates for Compliance Engineer role:
- Salary 70k - 75k
- Excellent benefits package – pension, health insurance including dental, life assurance, 25 days AL, share options and more
- Fantastic career development opportunities
What’s Next
- Apply now by clicking the “Apply Now" button, call Karolina on +353 091749267 or send your CV directly to kjaglowska@sigmar.ie
- Or if the job isn’t quite right but you are looking for something similar, please get in touch. We also have multiple Temp, FTC and Contract jobs available.
