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5974 - Senior CQV Engineer / Senior Validation Engineer

Fishers, IN

Description

Verista’s 500 experts team up with the world’s most recognizable brands in the life science industry to solve their business needs. The nature of our business is to empower growth and innovation within the scientific community and to help researchers, organizations, and companies solve some of the world’s most pressing healthcare challenges. Verista provides innovative solutions and services that empower informed decision-making and are the result of our significant investment in our people and our capabilities.

Our ability to grow is driven by world-class people who thrive in a team environment and share our mission to enable life sciences clients to improve lives. Our talented and dedicated professionals are committed to making an impact every day.

Company Culture Guidelines & Values:

  • We empower and support our colleagues
  • We commit to client success at every turn
  • We have the courage to do the right thing
  • We encourage an inclusive environment where our colleagues feel respected, engaged, and challenged.
  • We constantly acquire new skills and learn from our experiences to enhance our collective expertise

Senior CQV Engineer Responsibilities:

  • Periodic Reviews (PQE)
    • Ensure that validated systems, equipment, and processes remain in a state of control and continue to meet regulatory and business requirements
    • Develop and maintain a periodic review schedule based on risk, system criticality, and regulatory requirements
    • Collect relevant documentation: validation protocols/reports, change controls, deviations, calibration records, maintenance logs, and CAPA history
    • Prepare a Periodic Review Report summarizing findings, conclusions, and any corrective actions
  • Temperature Mapping (Initial and/or Requalification)
    • Verify that controlled temperature units (CTUs) or storage areas maintain uniform and acceptable temperature/humidity conditions
    • Develop a temperature mapping protocol outlining objectives, acceptance criteria, number and location of sensors, duration, and conditions
    • Summarize results, include mapping diagrams, raw data, conclusions, and recommend corrective actions
  • Onboarding Equipment (Lab and/or Process Equipment)
    • Ensure new equipment is installed, qualified, and integrated into the quality system in compliance with applicable regulations
    • Develop or approve qualification plan (IQ/OQ/PQ)
    • Execute approved test protocols (IQ/OQ/PQ or equivalent) to demonstrate that the system meets predefined requirements and functions as intended
  • Establish and maintain all validation lifecycle documents to ensure the computerized system is developed, implemented, and maintained in a controlled, compliant manner
  • Determine system impact, establish a risk-based validation approach, and develop key lifecycle deliverables in compliance with GxP and data integrity principles
  • Monitor and assess ongoing system performance and validation status to identify trends, deviations, or recurring issues that could affect system control or compliance

Requirements:

  • Must be willing to work onsite in Fishers, IN
  • Bachelor’s Degree in industry-related field required
  • Experience in a GMP regulated environment
  • Experience and capability of effectively communicating with different levels of the client’s organization
  • Demonstrated experience in leading CQV activities specific to Lab and/or Process Equipment
  • Ability to work as part of a team and independently
  • Strong problem-solving and critical thinking skills
  • Strong attention to detail
  • GMP and Good Documentation Practice

For US geography, the salary range for this position is shown below. The actual salary is dependent upon a variety of job-related factors such as professional background, training, work experience, location, business needs, market demand, and competitive market practice. Therefore, in some circumstances, the actual salary could fall outside of this expected range. This salary range is subject to change and may be modified in the future.

*Verista is an equal opportunity employer.

National (US) Range

$70,491 - $104,439 USD

Benefits

Why Choose Verista?

  • 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 (We have fun!)
  • Employee Recognition
  • Employee Referral Program
  • Paid Parental Leave and Bereavement

Verista collects and processes personal data in accordance with applicable data protection laws.  If you are a California Job Applicant, see the privacy notice for further details. 

For more information about our company, please visit us at Verista.com

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