Position Summary
The prospective candidate will mainly design, plan, manage, install, start-up, commission and document projects involving the Misterium (Mini Sterile Modular Room) and also new pharmaceutical equipment, clean room and utility systems. The prospective candidate will manage upgrade projects in support of existing systems for manufacturing processes and utilities.
Essential Duties and Responsibilities
2. Design and implement necessary utilities mainly HVAC looking forward for synergies with actual installations in the customer.
3. Design and implement process systems for clean rooms in pharmaceutical manufacturing and pharmacy operations.
4. Prepare scope of work, design and bid documents for systems fabrication and installation in close collaboration with sales department.
5. Propose design and implement upgrade projects for existing manufacturing and utility systems
6. Review all projects for compliance with USP Chapter <797> requirements and recommendations.
7. Responsible for project management of Misterium installations, requiring planning and organizing with sales team (representing the customer), the installation partner(s), and their subcontractors.
8. In the course of executing projects, follow the established Grifols procedures for pharmaceutical engineering documentation
Required Educational Qualifications
To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill, and/or ability required.
2. Familiarity with generally accepted good engineering practices and standards
3. Familiarity with local and national codes and standards as they relate to pharmaceutical projects
4. Familiarity with USP Chapter <797>
Required Experience/Skills
3. In depth knowledge of pharmaceutical clean room systems.
4. Knowledge of pharmaceutical grade water purification systems design and operation
5. Knowledge of mechanical systems including HVAC and refrigeration systems.
6.Knowledge of FDA guidelines for manufacturing of biologics preferred
7. AutoCAD drawing capability
8. Knowledge of Pharmacy workflow and USP Chapter <797> a plus.
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