Senior Cleanroom Engineer
About the Role
On behalf of our client a wellestablished and growing environmental services company we are hiring a Senior Cleanroom Engineer to join their expert team. Specialising in cleanroom validation calibration HVAC qualification and environmental monitoring the company supports clients across the pharmaceutical medical device and life sciences industries.
In this seniorlevel position you will play a key role in delivering cleanroom and controlled environment validation services to the highest standards of compliance and customer satisfaction. You will also provide technical leadership mentor junior engineers and contribute to process improvement project delivery and client relationship development.
Key Responsibilities
- Lead and execute cleanroom and controlled environment validation and qualification activities in compliance with GMP ISO 14644 and other relevant regulatory standards.
- Perform critical environmental tests including HEPA filter integrity testing nonviable particle counts airflow visualisation studies and differential pressure monitoring.
- Provide technical leadership and mentorship to junior validation and field engineers ensuring knowledge transfer and consistent quality delivery.
- Prepare highquality technical documentation including protocols reports and validation records for client submission.
- Liaise directly with clients to understand requirements resolve issues and ensure satisfaction with services delivered.
- Contribute to the development and refinement of internal SOPs validation templates and continuous improvement initiatives.
- Stay current with changes in relevant regulations standards and industry best practices.
- Manage multiple client projects simultaneously ensuring timely delivery and adherence to quality standards.
- Degree or equivalent qualification in Mechanical Engineering Environmental Science Life Sciences or a related discipline.
- Minimum 5 years of experience in cleanroom validation environmental monitoring or HVAC performance testing.
- Strong understanding of GMP guidelines ISO 14644 standards and regulatory expectations for cleanroom environments.
- Proven experience supporting clients in the pharmaceutical biopharma or medical device sectors.
- Proficiency with instruments and testing equipment including photometers particle counters and thermal anemometers.
- Excellent attention to detail technical report writing and customer communication skills.
- Strong interpersonal skills with the ability to build rapport with clients and collaborate effectively across multidisciplinary teams.
- Full clean EU driving licence and flexibility to travel to client sites across Ireland.
- Cleanroom Certification (e.g. CTCBI IEST).
- Six Sigma or Lean Manufacturing certification.
- Project Management qualification (e.g. PMP).
- Experience managing validation projects or acting in a team lead/senior engineer capacity.
- Familiarity with calibration or HVAC commissioning services.
- Competitive salary based on experience.
- Company vehicle or mileage reimbursement.
- Opportunities for career advancement and professional development.
- Supportive team culture and strong client relationships.
- Involvement in cuttingedge cleanroom technologies and highprofile projects.
Key Requirements
- Degree or equivalent qualification in Mechanical Engineering Environmental Science Life Sciences or a related discipline.
- Minimum 5 years of experience in cleanroom validation environmental monitoring or HVAC performance testing.
- Strong understanding of GMP guidelines ISO 14644 standards and regulatory expectations for cleanroom environments.
- Proven experience supporting clients in the pharmaceutical biopharma or medical device sectors.
- Proficiency with instruments and testing equipment including photometers particle counters and thermal anemometers.
- Excellent attention to detail technical report writing and customer communication skills.
- Strong interpersonal skills with the ability to build rapport with clients and collaborate effectively across multidisciplinary teams.
- Full clean EU driving licence and flexibility to travel to client sites across Ireland.
Desirable Qualifications & Experience
- Cleanroom Certification (e.g. CTCBI IEST).
- Six Sigma or Lean Manufacturing certification.
- Project Management qualification (e.g. PMP).
- Experience managing validation projects or acting in a team lead/senior engineer capacity.
- Familiarity with calibration or HVAC commissioning services.
Salary estimated