Zosano Pharma Corporation is a clinical-stage bio-pharmaceutical company focused on providing systemic administration of therapeutics to patients using our proprietary Adhesive Dermally-Applied Microarray, or ADAM technology. Our lead clinical asset, M207, has completed the pivotal ZOTRIP trial. Zosano is focused on developing products where rapid administration of established molecules with known safety and efficacy profiles provides an increased benefit to patients, for markets where patients remain underserved by existing therapies.
We are looking for an experienced, motivated individual to provide equipment and project expertise for the support of complex, automated, custom manufacturing equipment. The position includes all phases of support, from user requirements development, equipment manufacturing, acceptance testing and validation, troubleshooting, and machine modifications.
· Work with Process and Equipment engineering and other cross functional groups to improve equipment reliability and minimize equipment downtime.
· Diagnose equipment failures, find root cause, implement improvements to prevent equipment downtime.
· Identify improvements in machine performance, and implement upgrades.
· Work with Process engineering to create, implement, and improve PM procedures.
· Initiate, investigate, and resolve equipment related non-conformances and CAPAs.
· Develop, execute, and review validation protocols
· Participate in capital projects, new installations, testing, and modernization projects for new system.
· Work with Process engineering and manufacturing groups to develop user requirements.
· Interface with equipment suppliers to see that user requirements are met.
· Coordinate and attend acceptance testing at the manufacturer’s facility.
· The ability to prioritize and manage multiple projects concurrently under tight time constraints. Demonstrated commitment to proactive-planning and problem-solving.
· Be a self-starter and willing to tackle difficult technical issues.
· BS in Mechanical/Electrical Engineering or equivalent.
· Minimum 8years working as an equipment engineer in the biotechnology or pharmaceutical industry.
· Sound knowledge of pharmaceutical industry standards and guidelines, cGMP, GAMP, ICH, ASTM E2500
· Familiar with manufacturing equipment software, which includes Allen Bradley PLCs, programmable HMIs, vision inspection systems, Siemens PLCs, and ELAU Motion PLCs.
· Experience with Building Automation Systems (BAS).
· Must be willing and able to work flexible hours (nights and weekends).