Senior CQV Engineer - GMP Validation Lead (Columbus)

Verista

Columbus (OH)

On-site

USD 70,000 - 110,000

Full time

2 days ago
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Benefits offered by this job

High growth potential
Competitive pay
Life Insurance
Disability Insurance
Medical Insurance
Dental Insurance
Vision Insurance
401(k) Matching
Paid Time Off

Job summary

Verista, a leader in life sciences solutions, is seeking a Senior CQV Engineer to design and execute validation strategies for complex pharma processes and equipment. You will document qualification activities, assess risks, and ensure compliance with GMP standards while collaborating with cross-functional teams.

You will mentor junior staff, participate in audits, and contribute to process improvements in a fast-paced environment across Columbus, OH.

Qualifications

  • Bachelor’s degree required.
  • 4–6 years of demonstrated role relevant experience.
  • Ability to mentor and guide less experienced team members.
  • Experience leading CQV activities in pharmaceutical manufacturing.
  • GMP and Good Documentation Practice knowledge.

Responsibilities

  • Designing validation plans.
  • Conducting risk assessments with understanding of equipment and processes.
  • Maintaining detailed records of qualification and validation and change control for audits.
  • Designing and executing engineering studies for parameter definition and verification.
  • Authoring and editing testing/documentation for equipment/systems/ processes.
  • Running test scripts and documenting results.
  • Adhering to project schedules for all activities.
  • Documenting impact and risk assessments as part of a team.
  • Completing UI testing, software verification, and alarm testing on automated systems.
  • Developing, reviewing, and executing testing documentation.
  • Making design or process modification recommendations based on test results.

Skills

Mentoring teammates
Client communication
GMP knowledge
Problem solving
Documentation
Team collaboration
Time management
Attention to detail

Education

Bachelor's Degree

Tools

Microsoft Word
Excel
PowerPoint

Job description

Verista, a leader in life sciences solutions, is seeking a Senior CQV Engineer to design and execute validation strategies for complex pharma processes and equipment. You will document qualification activities, assess risks, and ensure compliance with GMP standards while collaborating with cross-functional teams.

You will mentor junior staff, participate in audits, and contribute to process improvements in a fast-paced environment across Columbus, OH.

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