Engineer, Validation

CSBio - Menlo Park, CA (30+ days ago)2.0


CSBio is a fast-paced growing peptide CMO founded in 1993. Our initial products were a complete line of automated synthesizers for manufacturing and process development, with a focus on cGMP production. In 1994, we opened our custom peptide facility and began producing high quality compounds for research organizations and pharmaceutical companies worldwide. In 2004, we opened our peptide production facility in Menlo Park, CA and in 2014, we expanded our production capability through the addition of a new, state of the art building dedicated to cGMP peptide production. In 2017, we passed a FDA inspection and were recommended to be approved for commercial drug substance manufacturing.

We are seeking a qualified individual to join us as a Validation Engineer at our Menlo Park facility. This position will support and coordinate Validation activities which may include manufacturing equipment, utility systems, facilities, laboratory instruments, and software within the company's GMP facility. Job responsibilities include the following:

Perform commissioning, qualification, and validation activities for facility, utility, equipment, and software; including developing project plans, preparing protocols, addressing discrepancies, and developing technical reports.
Author and execute IQ, OQ, and PQ qualifications and summary reports.
Develop and/or participate in generating validation lifecycle documentations, such as impact assessments, URS, FS, TM, etc.
Work with Quality, Operations, Manufacturing and Quality Control to establish, develop, communicate, and maintain all GMP equipment in validated state; this includes but is not limited to manufacturing equipment, facilities, computer systems, and laboratory instrumentation.
Manage and coordinate with external vendors to ensure the quality of the completed work.
Requirements

Engineering degree and a minimum of two years experience in pharmaceutical/biotech/medical device industry
Minimum of two years experience of validation experience (facility, utilities, equipment, CSV, cleaning, process, automation)
Working knowledge of cGMP and current industry practices in hardware/software validation and computerized systems
Must be self-motivated
Ability to work effectively and collaboratively in a cross-functional team within a fast-paced environment
Benefits

Competitive pay commensurate with experience
Medical, dental, and vision insurance
Basic life and supplemental life insurance
401k with matching up to 5%
Flexible PTO policy
Carpool, clean air vehicle, and cell phone reimbursement
Free shuttle program (trans-bay)
Employee rewards and recognition program
Free access to fitness center
Social events and catered lunch on Sat/Sun