Computer Validation Specialist

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

  • Utilize IT/IS, vendor, and client specifications to generate and execute testing protocols for computer 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, technology, or academic or environment
  • Experience writing and executing system testing, verification, and validation protocols and associated reports
  • Familiar with GAMP development methodology
  • Experience utilizing risk based methodologies in testing
  • Experience developing and/or testing various computer systems used in the pharmaceutical/biotech industry, such as: Corrective Action/Preventative Action Systems (CAPA), Manufacturing Execution Systems (MES), Document Management Systems (DMS), Learning Management Systems (LMS), Calibration Management Systems (CMS), Preventative Maintenance Scheduling Systems (PMS), Laboratory Information Management Systems (LIMS), Manufacturing Resource Planning Systems (MRP), and various standalone database systems.
  • Experience with contemporary server technology (physical and virtualized) and network infrastructure
  • Experienced with Office software such as Word and Excel
  • 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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