Sr. Staff Facilities Engineer - Sequoia Biotech Consulting
San Diego, CA
About the Job
Company Description
Sequoia Biotech Consulting is a leading life sciences consultancy, dedicated to empowering organizations to overcome complex challenges and accelerate the speed to market, scale, and quality of life-saving innovations. Our multidisciplinary team of scientists, engineers, quality experts, and business professionals specializes in optimizing product development, technology transfer, and commercial manufacturing. Additionally, we equip our partners with the tools, knowledge, and expertise to streamline operations, enhance quality, and ensure compliance.
For more information, visit www.sequoiabiotech.com/.
Sequoia is seeking a Sr. Staff Facilities Engineer to perform work on client projects within the life science industry. The ideal candidate must be an experienced engineer within the regulated space who is comfortable taking their experience and applying it to a variety of clients along the west coast.
Responsibilities
- Improves manufacturing processes and methods for cost-reduction, quality improvement and efficiency.
- Capable of troubleshooting mechanical components and suggesting and implementing improvements.
- Develop conceptual design and preliminary design documents, including, calculations, development of Process and Instrumentation Diagrams (P&IDs), and general arrangements.
- Layout of Ductwork systems based on a Process and Instrumentation Diagram (P&ID).
- Develop final design documents including specification, sequences of operation, piping layout, and final construction documents associated with systems.
- Prepares and presents improvement plans and coordinates deployment including training of team members.
- Work with client team members to produce development plans as well as identify and mitigate development risks
- Understand mechanical gaps in current equipment and implement improvements.
- Update and create production SOP's.
- Train and develop the plant mechanics to increase their ability to understand and troubleshoot mechanical and process related issues in the plant.
- Create/improve standard work for manufacturing.
Qualifications
- Bachelor's or Master's degree in Mechanical Engineering required
- 15+ years of professional experience, with at least 5 years within the regulated industry
- Extensive experience within the Pharma/Biopharma, Medical Device, or Biotech industry
- Experience with developing and designing criteria for HVAC systems
- Experience within a cGMP, FDA environment with knowledge of 21CFR820 and ISO13485
- Good communication skills both written and verbal
- Critical thinking with exceptional problem-solving skills, able to work independently and in team environments.
Additional Information
Sequoia offers a comprehensive suite of benefits including, medical, dental, vision coverage, 401K, and company paid life-insurance.
Sequoia is an equal opportunity employer & prohibits unlawful discrimination based on race, color, religion, gender, sexual orientation, gender identity/expression, national origin/ancestry, age, disability, marital & veteran status.