Validation Specialist

6 days ago


Durham, North Carolina, United States Verista Full time
About Verista

Verista is a leading provider of innovative solutions and services to the life science industry. Our team of experts works closely with top brands to empower growth and innovation within the scientific community.

Job Summary

We are seeking a highly skilled Validation Engineer - Quality Assurance Specialist to join our team. As a key member of our quality assurance team, you will be responsible for ensuring the quality and integrity of our products and services.

Key Responsibilities
  • Manage and collaborate with clients' quality representatives to investigate and resolve deviations and issues related to execution activities.
  • Support clients' change management programs, including authoring proposed changes, executing impact assessments, and documenting change results.
  • Author, edit, and execute technical commissioning, qualification, and validation documentation for standard equipment, systems, and software.
  • Run test scripts and document results.
  • Adhere to project schedules for all assigned activities.
  • Maintain clear, detailed records of qualification and validation.
  • Document impact and risk assessments as part of a team.
  • Complete user interface testing, software verification, and alarm testing on automated systems.
  • Develop, review, and execute testing documentation.
  • Make recommendations for design or process modification based on test results.
  • Read technical schematics to identify, locate, and test photo sensors, verify part numbers, and complete I/O testing on automated manufacturing equipment.
  • Have a general understanding of capital equipment implementation and process knowledge.
  • Understand validation documents, URS, IQ, OQ, PQ.
  • Verify system drawings, including reviewing and as-built P&IDs and I&C drawings, and verifying electrical schematics with support of an electrical engineer.
Requirements
  • Bachelor's Degree or equivalent required (STEM degree, Biomedical Engineering, Chemical Engineering preferred).
  • New College Grads are encouraged to apply.
  • Proficiency using PC and Microsoft Office tools.
  • Outgoing personality with strong ability to communicate effectively with peers in clear, concise terms.
  • Ability to work as part of a team.
  • Strong problem-solving and critical thinking skills.
  • Excellent organizational and time management skills.
  • Strong attention to detail.
  • 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.


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