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Validation Engineer Jobs

Company

Omni Consulting Services
Address , San Francisco, Ca
Employment type
Salary
Expires 2023-07-20
Posted at 11 months ago
Job Description
Validation Engineer / Consultant

Omni Consulting Services is a leading staffing firm focused in life science industry, we primarily serve biotech-pharma clients. Our services range from CQV, compliance, process-utilities engineering, project management, regulatory affairs and digitalization. This women- and minority-owned business is established in 2019 and encourages a work-family like culture. At Omni, we embrace diversity including everyone’s unique skills. Omni truly believe to grow together with our employees and clients; our employees are our assets!

We are looking for process / utility engineer with design, automation, commissioning, qualification, validation and start-up of various processes, systems and facilities. A combination of strong technical aptitude, interpersonal skills and technical writing with quality mindset are the desired skill set.

This is an excellent opportunity to join our growing team!

Responsibilities
  • Assist in deviation root cause analysis and corrective action plans.
  • 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.
  • Generate final and summary reports for executed test protocols
  • Experience with gene therapy / cell therapy is a plus.
  • Utilize engineering, vendor, and client specifications to generate and execute testing protocols for process systems, process equipment and utility systems following client procedures and good documentation practices
  • Temp. mapping or CQV experience is a must.
  • Generate and support higher level project documentation as required such as Masterplans, schedules, and summary reports.
  • Provide technical and compliance input into project execution strategies to ensure regulatory requirements are met.
  • Working in the full range of Biotech/pharma project phase execution including all design phases, construction, startup, CQV, and project hand-over activities.


Qualifications
  • Experience writing and executing commissioning, verification, and validation protocols and associated reports
  • 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
  • Experience with testing equipment and software such as Kaye Validators and Dataloggers
  • Experienced with Office software such as Word and Excel
  • Familiar with integrated commissioning and validation as well as ASTM E2500 verification methods
  • Travel may be required on occasion
  • Experience utilizing risk based methodologies in testing
  • 1 to 2+ years of experience in biotech, pharmaceutical, medical device, or academic or environment
  • Engineering or Scientific degree


Candidates please note: This job description is not all inclusive, other duties may be required, as assigned. 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. Interested candidates with direct related experience in US or Canada or Europe are encouraged to apply.