Senior Validation Engineer

6 days ago


Kalamazoo Michigan, United States Verista Full time
About the Role

We are seeking a highly skilled Senior Validation Engineer to join our team at Verista. As a Senior Validation Engineer, you will play a critical role in ensuring the quality and integrity of our products and services.

Key Responsibilities
  • Design and implement validation plans to ensure compliance with regulatory requirements.
  • Conduct and document impact and risk assessments to identify potential risks and opportunities for improvement.
  • Maintain accurate and detailed records of qualification and validation activities.
  • Author and execute technical commissioning, qualification, and validation documentation.
  • Run test scripts and document results to ensure compliance with project schedules.
  • Develop and review testing documentation to ensure accuracy and completeness.
  • Make recommendations for design or process modifications based on test results.
  • Collaborate with cross-functional teams to ensure effective communication and collaboration.
Requirements
  • 5-7 years of demonstrated CQV experience in GMP regulated environments.
  • Strong business maturity and interpersonal skills to effectively communicate and collaborate.
  • Experience and capability of effectively communicating requirements with rationale to different levels of the organization.
  • Outgoing personality with strong ability to communicate effectively with peers in clear, concise terms.
  • Ability to work as part of a team and collaborate effectively.
  • Strong problem-solving and critical thinking skills.
  • Excellent organizational and time management skills.
  • Strong attention to detail.
  • GMP and Good Documentation Practice.
  • Intermediate skills with WORD (authoring/editing large technical documents with styles, tables, TOCs, track changes).
  • Basic skills with EXCEL and PowerPoint.
What We Offer
  • 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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