Utility Engineer or Senior Utility Engineer

ADVENT Engineering, a Trinity Consultants company, is an engineering and consulting firm providing expertise to the pharmaceutical and biotechnology industries. Head-quartered near San Francisco, California, and with operations in the Eastern US and Canada, our company is involved in almost every facet of global pharmaceutical and biotechnology facility design and process engineering and quality system projects.

ADVENT's services include process engineering, automation engineering, project engineering, facility/system design, start up and commissioning, validation and compliance consulting for distinguished and successful biotechnology and pharmaceutical manufacturing companies.

The successful candidate will work with a group of engineers involved in the design, automation, commissioning and start-up of various processes, systems and facilities. A combination of strong technical aptitude, automation engineering skills and technical writing are the desired skill set.

This is an outstanding opportunity to join our growing team! Positions available in multiple U.S. locations - North Carolina, Boston, San Francisco Bay Area, Texas, etc.

Responsibilities

  • Provide technical leadership for design development, factory acceptance testing, installation, commissioning/ decommissioning, operation, monitoring, troubleshooting and/or maintenance of utility systems.
  • Oversight of technical changes, monitoring of system conditions, and investigation and implementation of corrective measures for work performed by others to ensure technical and regulatory aspects are met.
  • Working with full range of Biotech/pharma project phase execution including all design phases (conceptual design, basic design, detailed design), construction support and commissioning. You may support CQV (Commissioning, qualification and validation), shut-down, and project hand-over activities.
  • Generation of engineering specifications and drawings, review of process engineering documents, equipment/systems such as: WFI, Process Waste, PA, N2, Plant steam, Instrument Air, CIP, HVAC etc. Individual with HVAC only expertise in biotech-pharma may be considered.
  • Oversight and management of process engineers, provide guidance and leadership to colleagues in technical aspects, thoroughness and detail oriented in ensuring fulfillment of project deliverables of team.
  • Can include utility equipment and facility engineering, design, integration, documentation specification and validation.
  • You may be involved with other aspects such as client-management (maintain key Client relationships in support of business development and pursuit of new work), project scheduling/budgeting, coordination of client and ADVENT resources for effective project delivery, supporting business development (providing technical support to the sales as required for proposals/opportunities), presenting at industry conferences/publishing papers etc.  

Qualifications

  • 5 to 20+ years of experience in biotech/ biopharmaceutical environment.
  • Highly experienced with GMP regulations and the FDA regulatory process.
  • Demonstrated experience with equipment maintenance, operation, control, and cleaning for various equipment and systems. These utility systems include HVAC, WFI, CIP/SIP, process air systems, instrument air/nitrogen/process waste systems, and clean utility systems.
  • Demonstrated experience with clean/sterile equipment such as autoclaves and washers.
  • Provide leadership and expertise in capital projects and development of project design phases.
  • Experienced with P&IDs, engineering drawings, completion of walk-downs, system energization plans, lock-out tag-out, equipment vendor submittals, and clean utility engineering specifications.
  • Engineering degree in Chemical Engineering, Biochemical Engineering or Mechanical Engineering.
  • Travel may be required on occasion.
  • Permanent FTE or temporary/contract options available.

Candidates, please note:  Kindly ONLY apply if you meet the experience expectations described. Experience in GMP pharmaceutical and/or biotechnology facilities in engineering, quality or manufacturing is a MUST. Candidates with direct related experience interested in US or Toronto locations are encouraged to apply.

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