Pharmaceutical Clean Room Specialist
We are seeking an experienced and skilled pharmaceutical clean room specialist to join our team. This is a critical role that requires the ability to plan, design, and construct pharmaceutical clean rooms from concept through commissioning.
Key Responsibilities
* Coordinate with architects, contractors, vendors, and internal teams to ensure project specifications are met.
* Review and interpret construction drawings, technical specifications, and regulatory requirements.
* Monitor construction activities to ensure adherence to project timelines, safety protocols, and cGMP compliance.
* Track project budgets, change orders, and resource allocations to ensure cost-effective execution.
* Lead or support FAT, SAT, commissioning, and qualification (IQ/OQ/PQ) processes for clean room systems (HVAC, filtration, envelope, etc.).
* Ensure all documentation, including drawings, SOPs, and turnover packages, is accurate and complete.
* Participate in regular project meetings and provide updates on progress, risks, and mitigation strategies.
* Identify and resolve field issues quickly and effectively in collaboration with contractors and design teams.
* Ensure clean room classification standards (ISO 7/8, etc.) and environmental controls are implemented and verified.
Requirements
* Bachelor's degree in Engineering, Construction Management, or a related field.
* 3-5+ years of relevant experience in construction project engineering, preferably in the pharmaceutical or biotech industry.
* Direct experience in the design and construction of clean rooms, including knowledge of ISO classifications and HVAC/filtration systems.
* Strong understanding of GMP, FDA regulations, and clean room construction standards.
* Proficient in reading blueprints, P&IDs, and construction documents.
* Familiarity with project management software (e.g., MS Project, Primavera, or similar).
* Strong communication, organizational, and problem-solving skills.
* Ability to work in a fast-paced, regulated environment with multiple priorities.