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Sr. Staff Facilities Engineer

4 months ago


San Diego, United States Sequoia Biotech Consulting Full time

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.

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