Clean Room SME
- North America, East Coast
- Contract
- Life Sciences
Do you want to be part of a forward thinking global pharmaceutical client who have facilities in over 60 countries worldwide? Then this is the next step for you! One of our global pharmaceutical clients is currently requiring an experienced Clean Room SME for their Raleigh based location.
What you'll do:
- Lead clean room design and implementation in alignment with ISO 14644 and GMP/cGMP standards, ensuring layouts, finishes, and airflow meet regulatory requirements.
- Oversee construction and installation of clean room components (walls, ceilings, HVAC, HEPA filters, etc.) and ensure integration of equipment and monitoring systems.
- Conduct inspections, audits, and qualification activities, resolving deviations and ensuring documentation meets compliance standards.
- Act as the clean room subject matter expert, collaborating with cross-functional teams and serving as the main contact for quality and compliance issues.
- Requires extensive experience in clean room design, construction, and validation within pharmaceutical or life sciences environments.
- Proven expertise in ISO 14644 standards, GMP/cGMP regulations, and contamination control.
- Experience leading clean room projects from concept through commissioning.
- Strong understanding of HVAC systems, airflow dynamics, and pressure balancing in controlled environments.
- Excellent communication, leadership, and organizational skills.
- Proficiency in quality management systems, document control platforms, and MS Office Suite.
#LI-MC1
Once again can I via you recognise the superb support I was given before, during and after this short contract. The support, was as usual professional and every friendly.
QA Specialist
I have always received a highly professional & personable service from the team at QCS Staffing. They listen carefully to the specific requirements of available roles and work tirelessly to supply a pool of potential candidates and make the hiring and contract renewal process an easy activity to manage.
Global Pharmaceutical firm
We have worked together with QCS Staffing for seven years now and have always received a professional service. QCS Staffing's speciality certainly lies within their technical sourcing abilities and they have met our demanding requirements time and time again. Coupled with this are the integrity of QCS Staffing's people and their ability to deliver.
Global Pharmaceutical firm
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Mark
I manage this role.