CQV Engineer - Senior Validation Engineer

Verista's 600 experts team up with the world's most recognizable brands in the life science industry to solve their business needs.
Kalamazoo, MI, USA
$70,491 - $118,941
Backend
Senior Software Engineer
In-Person
501 - 1,000 Employees
5+ years of experience
Healthcare · Biotech

Description For CQV Engineer - Senior Validation Engineer

Verista is seeking a Senior CQV (Commissioning, Qualification, and Validation) Engineer to join their team. This role involves designing validation plans, conducting impact and risk assessments, and maintaining detailed records of qualification and validation activities. The ideal candidate will have 4-6 years of relevant experience, a Bachelor's degree, and strong skills in communication, problem-solving, and attention to detail.

Key responsibilities include:

  • Designing and executing engineering studies for critical process parameter definition
  • Authoring and executing technical commissioning, qualification, and validation documentation
  • Running test scripts and documenting results
  • Completing user interface testing, software verification, and alarm testing on automated systems
  • Making recommendations for design or process modifications based on test results

The role requires working on-site in Kalamazoo, MI, and offers a competitive salary range of $70,491-$118,941, along with a comprehensive benefits package including medical, dental, and vision insurance, 401(k) with employer matching, paid time off, and various other perks.

Verista values empowering colleagues, committing to client success, doing the right thing, and fostering an inclusive environment. They are looking for candidates who can thrive in a team environment and are passionate about making an impact in the life sciences industry.

Join Verista to be part of a high-growth organization with a people-focused culture, working on innovative solutions that empower informed decision-making in the scientific community.

Last updated a month ago

Responsibilities For CQV Engineer - Senior Validation Engineer

  • Designing validation plans
  • Conducting and documenting impact and risk assessments
  • Maintaining clear, detailed records of qualification and validation activities
  • Designing and executing engineering studies for critical process parameter definition
  • Authoring, editing, and executing technical commissioning, qualification and validation documentation
  • Running test scripts and documenting results
  • Completing user interface testing, software verification, and alarm testing on automated systems
  • Developing, reviewing, and executing testing documentation
  • Making recommendations for design or process modification based on test results

Requirements For CQV Engineer - Senior Validation Engineer

  • Bachelor's Degree or equivalent
  • 4 - 6 years of demonstrated role relevant experience
  • Experience in GMP regulated environment
  • Proficiency using PC and Microsoft Office tools
  • 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
  • Basic skills with EXCEL and PowerPoint
  • Strong interpersonal skills and clear communication capabilities
  • Experience with and tolerance for high levels of challenge and change
  • Ability to work as part of a team
  • Ability to mentor and guide less experienced team members
  • Ability to communicate effectively with clients
  • Must be willing to work onsite in Kalamazoo, MI

Benefits For CQV Engineer - Senior Validation Engineer

401k
Commuter Benefits
Dental Insurance
Education Budget
Medical Insurance
Mental Health Assistance
Parental Leave
Vision Insurance
  • 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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