Validation Engineer or Senior Validation Engineer

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, Midwest, Gulf Coast, 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, compliance mindset, commissioning/qualification 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

  • Utilize engineering, vendor, and client specifications to generate and execute testing protocols for process equipment and utility systems following client procedures and good documentation practices
  • Assist in deviation root cause analysis and corrective action plans
  • Generate final and summary reports for executed test protocols
  • Provide technical and compliance input into project execution strategies to ensure regulatory requirements are met.
  • Generate and support higher level project documentation as required such as Masterplans, schedules, and summary reports.
  • Working in the full range of Biotech/pharma project phase execution including all design phases, construction, startup, CQV, and project hand-over activities.
  • 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, medical device, or academic or environment
  • Experience writing and executing commissioning, verification, and validation protocols and associated reports
  • Familiar with integrated commissioning and validation as well as ASTM E2500 verification methods
  • Experience utilizing risk based methodologies in testing
  • Experience with manufacturing processes and equipment such as CIP/COP systems, filtration skids, chromatography, fermentors/bioreactors, sterilization, and lyophilization equipment
  • Experience with hygienic utility systems such as purified water, WFI, clean steam, and process air
  • Experienced with Office software such as Word and Excel
  • Experience with testing equipment and software such as Kaye Validators and Dataloggers
  • Engineering or Scientific degree
  • 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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