Senior Validation Engineer

3 weeks ago

Germantown, Wisconsin, United States Verista Full time
Job Description

Verista is seeking a highly skilled Senior CQV Engineer to join our team. As a key member of our team, you will be responsible for managing multiple projects and clients, driving activities as a client-facing leader, and acting as the point of escalation and issue management on client projects.

Key Responsibilities:

  • Design and execute validation plans
  • Conduct and document impact and risk assessments
  • Verify system drawings and electrical schematics
  • Author and execute technical commissioning, qualification, and validation documentation
  • Run test scripts and document results
  • Maintain clear, detailed records of qualification and validation
  • Develop and review testing documentation
  • Make recommendations for design or process modification based on test results

Requirements:

  • Demonstrated experience in Commissioning & Validation activities covering URS (GMP equipment)
  • Demonstrated experience authoring and executing FAT, SAT, IOQ, CSV Protocols
  • Specific experience with 6 reactors (2,000gal+)/receivers, Filter Dryers, Centrifuges, Core Dryers, Powder handling systems, clean rooms, support facilities, and tank farms preferred
  • 5-7 years of demonstrated CQV experience in GMP regulated environments
  • Obvious business maturity and interpersonal skills to effectively communicate and collaborate
  • Experience and capability of effectively communicating requirements (written and orally) with rationale to different levels of the client's organization
  • Proven attention to detail and organization in project work
  • Capable of working on assigned tasks without mentorship
  • GMP and Good Documentation Practice training (may be completed at onboarding)
  • Intermediate skills with WORD (authoring/editing large technical documents with styles, tables, TOCs, track changes)
  • Basic skills with EXCEL and PowerPoint
  • Strong interpersonal skills and clear communication capabilities

Benefits:

  • High growth potential and fast-paced organization with a people-focused culture
  • Competitive pay plus performance-based incentive programs
  • Company-paid Life, Short-Term, and Long-Term Disability Insurance
  • Medical, Dental & Vision insurances
  • FSA, DCARE, Commuter Benefits
  • Supplemental Life, Hospital, Critical Illness, and Legal Insurance
  • Health Savings Account
  • 401(k) Retirement Plan (Employer Matching benefit)
  • Paid Time Off (Rollover Option) and Holidays
  • As Needed Sick Time
  • Tuition Reimbursement
  • Team Social Activities
  • Employee Recognition
  • Employee Referral Program
  • Paid Parental Leave and Bereavement

Why Choose Verista?

Verista is an equal opportunity employer.

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