6590 - CQV Engineer - Change Control & Deviations

veristainc; Indianapolis (IN); Sur place; USD 69 000 - 103 000; Plein temps

Avantages offerts par ce poste

Competitive pay

Medical, Dental & Vision insurances

401(k) Retirement Plan (Employer Match

Paid Time Off

Tuition Reimbursement

Résumé du poste

Verista is seeking a CQV Engineer to support change control and deviation management in a regulated cGMP environment. The role emphasizes validation lifecycle activities (IQ/OQ/PQ) and strong technical writing within a collaborative team.

The ideal candidate will have 1–3 years of CQV/Validation experience and bachelor's degree in Chemistry, Engineering, Life Sciences, or a related field. Onsite work is required in Indianapolis, IN, with opportunities to impact product quality and compliance.

Qualifications

• Bachelor's degree in Chemistry, Engineering, Life Sciences, or related field.
• 1-3 years of CQV, Validation, or Quality Engineering in a regulated industry.
• Experience supporting validation lifecycle activities (IQ/OQ/PQ).
• Strong technical writing and documentation skills.
• Excellent communication and cross-functional collaboration abilities.

Responsabilités

• Author, review, and manage change controls impacting systems, equipment, and processes.
• Perform impact assessments, including evaluation of product quality, validated state, and regulatory impact.
• Collaborate with cross-functional teams (Scientists, Quality) to ensure timely and compliant change implementation.
• Support execution of change control deliverables, including tracking/updating documentation.

Connaissances

Change control systems

cGMP GDP environments

Technical writing

Cross-functional collaboration

Analytical testing knowledge

Formation

Bachelor's degree in Chemistry, Engineering, Life Sciences, or related field

Description du poste

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

We are seeking a CQV Engineer to support change control and deviation management activities. This role will play a critical part in maintaining compliance, supporting quality systems, and ensuring manufacturing changes are properly assessed, documented, and executed in a regulated cGMP environment.

The ideal candidate will have hands-on experience in change management and CQV lifecycle support within pharmaceutical or medical device manufacturing.

Validation Engineer / CQV Engineer Responsibilities

Change Control Management

• Author, review, and manage change controls impacting systems, equipment, and processes
• Perform impact assessments, including evaluation of product quality, validated state, and regulatory impact
• Collaborate with cross-functional teams (Scientists, Quality) to ensure timely and compliant change implementation
• Support execution of change control deliverables, which could include tracking/ updating to documentation

CQV & Compliance Support

Analytical Development

• Maintain alignment with cGMP and Good Documentation Practices (GDP)
• Support impact assessments and execution activities related to changes
• Review and approve technical documentation as required
• Participate in audits and inspections, providing SME support for change control and deviation processes

Cross-Functional Collaboration

• Interface with Analytics, Quality Assurance, , and Engineering teams
• Support continuous improvement initiatives related to quality systems and CQV processes
• Communicate project status, risks, and issues to stakeholders

Requirements

• Bachelor's degree in Chemistry, Engineering, Life Sciences, or related field
• 1-3 years of experience in CQV, Validation, or Quality Engineering in a regulated industry - Entry-level candidates encouraged to apply
• Strong experience with:
  • Change control systems
  • cGMP and GDP environments
• Familiarity with analytical testing and Chemistry is highly preferred
• Experience supporting validation lifecycle activities (IQ/OQ/PQ) is a plus
• Strong technical writing and documentation skills
• Excellent communication and cross-functional collaboration abilities

Onsite job requirement in Indianapolis, IN

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

$69,300 - $102,623 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 ReimbursementTeam Social Activities (We have fun!)
• Employee Recognition
• Employee Referral Program
• Paid Parental Leave and Bereavement

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