Facilities and Equipment Specialist Biotechnology
Alcock & McFadden - San Diego, CA

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Our client is a San Diego-based contract development and manufacturing organization that specializes in cGMP manufacturing, analytical development, formulation development, aseptic filling into vials & syringes, and protein delivery technology for recombinant protein and parenteral products.

The successful candidate will oversee all equipment scheduling, installation, repair, maintenance, and calibration. He/She will interact with construction team members regarding facility needs of the facility expansion plans. The Facilities and Equipment Specialist will coordinate with department leads regarding facility equipment needs. Additionally, the successful candidate will write change of controls to document activities per company SOP's. He/She will be on call for facility emergency issues, including all alarm monitoring of critical equipment. The Facilities and Equipment Specialist will schedule major equipment repairs with external vendors and perform in-house maintenance as necessary. Responsibilities will include coordinating facility validation with internal validation department and external consultants. He/she will specialize in the maintenance, repair, and calibration of the purified WFI and USP water systems, plant and clean steam systems, and clean compressed air systems, autoclaves and lyophilizers. He/she will solicit quotations and review vendor proposals within area of responsibility. Makes decisions related to trouble shooting of the facilities and equipment. Makes decisions on operations and maintenance of critical equipment and systems. Handles emergencies on vital equipment. Makes recommendations to management on equipment performance and design improvements. The Facilities and Equipment Specialist will disassemble and assemble equipment to gain access to, remove, and repair or replace defective components. He/She will coordinate maintenance activities with manufacturing leads and supervisors so as to minimize disruptions to manufacturing. This position is responsible for performing preventive maintenance of equipment and machinery.

The qualified candidate will have an Associates degree in related discipline or equivalent experience and three to five (3-5) years relevant hands on experience in facility maintenance within the biotech industry. He/She will possess strong mechanical and electrical troubleshooting skills. A knowledge of applicable regulatory requirements including cGMP regulations is required. A functional knowledge of major utility systems, including HVAC equipment, plant and clean steam systems, clean compressed air systems, USP and WFI water systems, electrical systems and cGMP equipment typically utilized in manufacturing facilities is also required. The qualified candidate must be familiar with electrical controls, instrumentation (flow, pressure and temperature). Ability to read and document electrical prints. He/She must have understanding of process controls, good knowledge of using hand tools, power tools, measuring tools and diagnostic tools. This position requires a detail oriented person with strong written and verbal communication skills. He/She must have the ability to work independently, within prescribed guidelines, or as a team member. A familiarity with Microsoft Office applications is required. The qualified candidate must be able to work swingshift and/or weekend shifts as needed.