6567 - CQV Engineer / Validation Engineer 2

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

We are seeking a CQV Engineer with a strong background in validation within a regulated pharmaceutical, biotechnology, or life sciences manufacturing environment. This position will primarily focus on the review of validation and qualification documentation to ensure accuracy, completeness, technical quality, and compliance with applicable regulatory and company requirements. The ideal candidate will have at least 3 years of validation experience, a solid understanding of the validation lifecycle, and hands-on experience with process equipment such as tanks, reactors, vessels, and related manufacturing systems.

CQV Engineer Responsibilities:

• Review commissioning, qualification, and validation documentation for accuracy, completeness, consistency, and compliance.

• Review protocols, test scripts, reports, deviations, and supporting validation documentation.

• Verify that qualification activities and documentation meet approved procedures, specifications, acceptance criteria, and applicable GMP requirements.

• Apply a strong understanding of the validation lifecycle, including commissioning, IQ, OQ, PQ, and validation closeout.

• Review documentation associated with process and manufacturing equipment, including tanks, reactors, vessels, and similar systems.

• Identify documentation gaps, discrepancies, and compliance concerns and work with Engineering, Validation, Quality, and Operations teams to resolve them.

• Ensure validation documentation follows Good Documentation Practices (GDP) and is inspection/audit ready.

• Support validation and qualification activities as needed.

Requirements:

• Bachelor’s degree in Engineering, Life Sciences, or a related technical discipline preferred.

• 3+ years of validation/CQV experience within pharmaceutical, biotechnology, medical device, or another regulated manufacturing environment.

• Experience with process equipment such as tanks, reactors, vessels, or similar manufacturing systems strongly preferred.

• Strong understanding of commissioning, qualification, and validation principles and lifecycle documentation.

• Knowledge of GMP and Good Documentation Practices.

• Demonstrated experience reviewing technical validation documentation.

• Excellent attention to detail and ability to identify documentation and compliance issues.

• Strong written and verbal communication skills.

• Ability to work effectively with Engineering, Quality, Validation, Manufacturing, and other cross-functional teams.

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

$73,920—$118,062 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

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