Process Engineer or Senior Process Engineer (Biotech)

ADVENT Engineering, a Trinity Consultants company, is an engineering and consulting firm providing expertise to the pharmaceutical and biotechnology industries. Headquartered 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 on design, commissioning and start-up of various processes, systems and facilities. Undertake technical reviews for documents generated by others to ensure that technical and regulatory requirements 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.
  • Can include process equipment and facility engineering, design, integration, documentation specification and validation.
  • Generation of engineering specifications and drawings, review of process engineering documents, equipment/systems such as: fermentors, chromatography systems, high purity water and steam systems), control systems, vial and syringe filling equipment as well as Isolators.
  • 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.
  • 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-pharmaceutical academic or industrial environment
  • Led projects as technical lead(s) for mid to large projects involving multiple process units with a significant degree of complexity
  • Highly experienced with upstream and downstream bioprocess operations, and fill-finish systems
  • Demonstrated experience with manufacturing processes and equipment such as CIP systems, filtration skids, chromatography and lyophilization equipment
  • Provide leadership and expertise in capital projects and development of project design phases (conceptual design, basic design, detailed design) and commissioning
  • Experienced with software such as AutoCAD, Schedule Pro/Super Pro or other similar process simulation and scheduling software
  • 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 design, 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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