This position is responsible for oversight of GMP/GLP equipment qualification, which includes introduction of new GMP/INDe equipment, modifications to existing equipment. Provides technical expertise on Quality Assurance standards and processes.
What You'll Do:
- Lead and manage initiation of Qualification protocols(IQ, OQ, PPQ) for GMP and GLP.
- Lead Equipment Management and Ensure all GMP/GLP equipment preventive Maintenance and/or Calibration activities including scheduling and documentation.
- Support and work closely with Equipment, software and other system vendors to ensure Maintenance activities are scheduled in a timely manner.
- Lead and manage investigation of Equipment failure reports (Deviations) and Change controls
- Support Computer System Validations by authoring Test cases and performing executions.
- Lead and manage validation/qualification status for GMP equipment, facilities and utilities.
- Ensure equipment and systems are labeled with their qualification and calibration information and Update equipment and system information accordingly in QMS and Equipment Management Databases.
- Responsible for revising equipment management SOPs and Validation Master Plans based on the outcome of the validation activities.
- Identifies, classifies and reports deviations, as appropriate and provides QA oversight of deviations and CAPA
- Ensure all the execution activities are done per Good Documentation/Manufacturing practices.
- Requires Bachelor’s or Master’s degree from an accredited institution in Science (Chemistry, Biochemistry, Microbiology)
- Requires 3+ years of experience of Quality or Validation experience
- GMP experience from Pharma/Biotech/Consumer Goods industries
- Experience working with CMMS/EMS systems and QMS system
- Strong attention to detail
- Good collaborative and team oriented skills to work well with the rest of the organization
- Ability to think on one's feet and change direction easily to accommodate the situation at hand
Company Perks & Benefits
- Generous equity
- Medical, dental, and vision benefits
- 401k Program
- Subsidized catered lunches and dinners with a fully stocked kitchen & snacks
- Onsite Gym
- Daily Shuttle bus to & from San Francisco
- Paid parental leave
- Flexible paid time off
- Learning and Development resources
Synthego is a genome engineering company that enables the acceleration of life science research and development in the pursuit of improved human health.
The company leverages machine learning, automation, and gene editing to build platforms for science at scale. With its foundations in engineering disciplines, the company’s platforms vertically integrate proprietary hardware, software, bioinformatics, chemistries, and molecular biology to advance basic research, target validation, and clinical trials.
By providing both commercial and academic researchers and therapeutic developers with unprecedented access to cutting-edge genome engineering, Synthego is at the forefront of innovation, accelerating the development of truly engineered biology.