Job Listing: Facilities Process Engineer (Biomedical/Diagnostics fie
Seeking someone who has large scale validation experience in the medical field.
We are seeking a candidate with 10 years of experience.
This person will determine the appropriate strategy and evolution of our corporate facilities structures, systems, processes and equipment and the impact on the strategic and daily product.
Additional duties include:
Developing, implementing and managing project plans including capital expenditures, managing contract service providers, will interact and maintain compliance with governing agencies including local, state and the FDA.
Overall, 24 hour responsibility for the reliability and operation of manufacturing and laboratory environments, processes including lyophilization equipment, dehumidification equipment, dry rooms, cold rooms and clean rooms.
Also includes the development of specifications for new manufacturing support and facilities equipment, writing and executing validation procedures, layouts and integration within the existing structure, processes and culture.
Provide training of technicians in the areas of facilities and process support equipment, including the operation and maintenance of lyophilization equipment and processes, HVAC, compressors, chillers, refrigeration units and dehumidification / dry room equipment.
Develop and implement maintenance plans, system upgrades and continuous improvement programs for clients specific processing systems to optimize operational efficiencies. Work with technicians and/or contractors to achieve results.
Generate schematics for our mechanical and electrical systems
Validate systems / coordinate validation using outside contractors
Write system maintenance plans
Implement safety procedures and design controls
This is a highly collaborative position which interfaces with our mechanics and technicians, all levels of Production, Engineering, R&D, Safety, Contractors and Regulatory Agencies.
Required Skills
Must possess thorough understanding of QSR and ISO regulations related to facilities operations.
Must have thorough understanding of all building codes.
Must have thorough understanding of all Federal/State/County/City regulations as they relate to facilities operations.
Must have thorough understanding (hands on ability) of all facilities equipment and systems including: Equipment Process Alarm Monitoring System, HVAC Systems, Refrigeration, Lyophilization, Environmental Controls, Electrical Distribution / Emergency Generator
Must have ability to train Mechanics & Technicians
Must have ability to use MS word and create basic spreadsheets (MS Office)
Must have ability to write instructions and procedures (including equipment IQ/OQ)
Must have ability to effectively communicate with other functional areas.
Must have ability to prioritize multiple tasks and work independently.
Minimum 10 years progressively responsible experience with facilities equipment and systems is required
Minimum 2 years experience in high volume manufacturing and laboratory environments is required - Required
Minimum 5 years hands on experience with lyophilization processes and equipment required.
Experience managing multiple projects concurrently - Required
Technical understanding and experience in HVAC/Refrigeration/Electrical, Water Systems at a level appropriate to supervising and directing technicians/mechanics in this work - Required
Experience in QSR/ISO 9000 manufacturing environment - Required
Experience managing preventative maintenance programs - Required
Experience managing quality systems (calibration program) - Preferred
Experience writing operating and validation procedures - Required
Job Details |
Job Location |
Candidate Application |
| Employer: Volt Staffing | Address: | Contact: |
| Job Type: Full-time | City: San Diego | Phone: 858-279-5801 |
| Experience: | State: California | |
| Education: Any | Zip Code:92126 | Online: Website Link |
Salary and Benefits
DOE
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