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Cgmp Validation Maintenance Engineer

Company

Stanford University
Address , Stanford, Ca
Employment type FULL_TIME
Salary $80,000 - $122,000 a year
Expires 2023-07-11
Posted at 1 year ago
Job Description

The mission of the Office of Facilities Planning and Management (OFPM) in the School of Medicine (SoM) is to plan for and manage the facilities needs of the School of Medicine community in the areas of facilities operations, capital planning and budgeting, projects from programming through occupancy, space inventory, and facility assets.

In the pursuit of this mission, the office now has an immediate opening for a cGMP Validation Maintenance Engineer. This person will report directly to the SoM Facilities Area Manager, and perform specialized, diverse work activities and coordinate solutions, working independently, solely supporting the operations, maintenance, repair, upkeep, inventory tracking, and refurbishing activities related to the physical environment and building systems of the Stanford Laboratory for Cell and Gene Medicine, which manufactures cell-based therapies. Additionally, this individual will provide facilities operations support to a newly constructed Animal Biosafety Level 3 facility housed in SoM’s Veterinary Service Center. This position is a 100% onsite position.

Duties include:

  • Plan, execute, validate, calibrate, and perform preventive maintenance (PM) on building systems, building automation, and fire life safety systems, according to cGMP guidelines for manufacturing cell-based therapies.
  • Locate and diagnose failures, replace defective components, and occasionally perform basic troubleshooting using hand & power tools, test equipment, mathematics, operating manuals, specifications, prints, and verbal/written instructions.
  • Participate in ABSL-3 meetings and workgroups as related to facilities issues to help identify safety issues and develop responses or mitigation procedures.
  • Generate and review calibration and preventive maintenance documentation.
  • Provide engineering assistance for and participate in emergency repairs as a member of an Emergency Response Team, as needed.
  • Responsible for working with QA to determine qualification, calibration, and PM requirements for building systems to comply with cGMP regulations.
  • Host weekly meetings and present at monthly All Hands to update customers on facilities related work/projects and issues.
  • Ensure HEPA certifications are performed on time and review all associated documents to verify that all parameters are met. Create new and/or update SOP on installation and maintenance of HEPA filters.
  • Administer calibration, preventive maintenance and qualification database.
  • Work with QA Department to ensure compliance with Validation Master Plan and cGMP Guidelines.
  • Assist OFPM in the execution of renovation and upgrade projects.
  • Work closely with the SLCGM Executive Director and Director of QA/QC as part of a SLCGM compliance team.
  • Consult with Safety & Emergency Management/E&HS, Facilities Operations, and the VSC regarding ABSL-3 facilities related emergencies.
  • Generate and review qualification protocols and summary reports for qualification activities performed by outside vendors.
  • Facilitate annual ABSL-3 HVAC shutdown, emergency power testing, and preventive maintenance in conjunction with hired certification consultant and the Veterinary Service Center.
  • Regularly review and update all SOPs/forms related to facilities and facilities maintenance.
  • Other duties may also be assigned.

DESIRED QUALIFICATIONS:

  • Demonstrated proficiency with Building Automation and Fire Life Safety systems.
  • 5+ years of experience in a cGMP pharmaceutical/biotech environment is desired.
  • Demonstrated proficiency in three of the following disciplines: plumbing, pipefitting, electrical, instrumentation, refrigeration, HVAC, machinist or mechanical.
  • 5+ years of experience in maintaining and troubleshooting industrial mechanical and electrical systems is preferred.


EDUCATION & EXPERIENCE (REQUIRED):

Bachelor’s degree and five years related, demonstrated technical facilities management experience, or a combination of education and experience.

KNOWLEDGE, SKILLS AND ABILITIES (REQUIRED):

  • Working knowledge of applications such as Excel, Word, PowerPoint, Project.
  • Background knowledge of safe handling and disposal of chemicals and hazardous waste; emergency preparedness plans and their implementation; and property administration specific to PO tracking, receiving, and inventory control.
  • Ability to coordinate and manage multiple projects with competing priorities, meet deadlines and project plans with short- and long-term end dates.
  • Analytical skills to analyze and track complex space, equipment and financial data.
  • Experience working with internal and external vendors and services contracting.
  • Interpersonal skills, mature judgment required to interact effectively with a broad range of people, including faculty and vendors, both individually and in groups.

CERTIFICATIONS & LICENSES:

Valid California Non-commercial Class Driver’s license.

PHYSICAL REQUIREMENTS*:

  • Rarely, kneel/crawl, grasp forcefully, sort/file paperwork or parts, lift/carry/push/pull objects that weigh >40 pounds.
  • Frequently stand/walk, seated, performs desk-based computer tasks.
  • Ability to obtain and maintain a California Non-commercial Class Driver’s license and drive day or night.
  • Occasionally climb (ladders, scaffolds, or other), twist/bend/stoop/squat, reach/work above shoulders, grasp lightly/fine manipulation, use a telephone, writing by hand, lift/carry/push/pull objects that weigh up to 20 pounds.
  • - Consistent with its obligations under the law, the University will provide reasonable accommodation to any employee with a disability who requires accommodation to perform the essential functions of his or her job.

WORKING CONDITIONS:

  • May be exposed to noise > 80dB TWA.
  • Requires 24-hour response availability seven days per week for emergency situations.
  • May work at heights 4 – 10 ft.


WORK STANDARDS:

  • Subject to and expected to comply with all applicable University policies and procedures, including but not limited to the personnel policies and other policies found in the University’s Administrative Guide, http://adminguide.stanford.edu.
  • Interpersonal Skills: Demonstrates the ability to work well with Stanford colleagues and clients and with external organizations.
  • Promote Culture of Safety: Demonstrates commitment to personal responsibility and value for safety; communicates safety concerns; uses and promotes safe behaviors based on training and lessons learned.
  • Must comply with the California Vehicle Code and Stanford University requirements when operating university-owned vehicles.

The expected pay range for this position is $80,000.00 to $122,000.00 per annum. Stanford University provides pay ranges representing its good faith estimate of what the university reasonably expects to pay for a position. The pay offered to a selected candidate will be determined based on factors such as (but not limited to) the scope and responsibilities of the position, the qualifications of the selected candidate, departmental budget availability, internal equity, geographic location and external market pay for comparable jobs.


As an organization that receives federal funding, Stanford University has a COVID-19 vaccination requirement that will apply to all university employees, including those working remotely in the United States and applicable subcontractors. To learn more about COVID policies and guidelines for Stanford University Staff, please visit https://cardinalatwork.stanford.edu/working-stanford/covid-19/interim-policies/covid-19-surveillance-testing-policy.