Validation Consultant

Zifo

$90K — $120K *
Pharmaceuticals & Biotech
8 - 10 years of experience
Job Overview by Ladders

Qualifications

  • Bachelor's or master's degree in a scientific or health care field
  • 8-10 years of experience as a Validation Analyst/consultant in the pharmaceutical/life sciences industry
  • Strong understanding of validation life cycle documentation and practices
  • Experience with analytical instruments for validation, such as spectroscopy and chromatography
  • Familiarity with software development life cycle (SDLC) processes and methodologies like Agile

Responsibilities

  • Create and support the review of validation life cycle documents
  • Consult clients on data integrity requirements for analytical instruments
  • Author and route validation life cycle documents for client approval
  • Execute approved protocols in GxP facility
  • Manage change controls through compliance processes
  • Collaborate with global teams on validation project deliverables

Benefits

  • Accrued vacation
  • Medical, dental, and vision insurance
  • 401k with company matching
  • Life insurance
  • Flexible spending accounts
Full Job Description
Zifo is looking for a Validation Consultant to join their team of laboratory IT (lab computing, Lab IT systems, QA, Validation) professionals.

**This role will require a 100% on-site presence at the client site in Chicago, IL**

**This role is not eligible for relocation assistance**

Requirements

Responsibilities:
    • Create and support review of validation life cycle documents for Analytical Instrument Qualification and computerized systems
    • Experience in validation of analytical instrument systems (e.g. benchtop analytical systems - spectroscopy, chromatography, protein analyzers, next gen sequencers, PCRs etc.)
    • Consult clients on data integrity requirements in Analytical Instruments and perform verification of DI in the systems
    • Author validation life cycle documents for client's review and approval
    • Route drafted documents for review
    • Route reviewed documents for workflow approval
    • Request approval workflows to Doc Control
    • Execute approved protocols in GxP facility
    • Understand SDLC process and SDLC methodology such as agile etc.
    • Work with global team in delivering validation project deliverables
    • Manage change controls necessary for project life cycle through process compliance and interface with Quality Assurance change control area
    • Author change control documents for client review and approval


Qualifications:
  • Bachelor's/ master's degree or equivalent in a scientific or health care field.
  • 8-10 years of experience as a Validation Analyst / consultant preferably in the pharmaceutical /Life sciences industry preferred.


A successful Zifo-ite is:
  • Independent, Self-Motivated & Results driven
  • Willing & able to quickly acquire new Technical Skills & Business Principles
  • A critical thinker who possesses logical reasoning
  • Curious and always looking for creative solutions to complex problems

Benefits

We offer a competitive compensation package including accrued vacation, medical, dental, vision, 401k with company matching, life insurance, and flexible spending accounts.

If you share these sentiments and are prepared for the atypical, then Zifo is your calling!

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