Senior CQV Engineer / Senior Validation Engineer- 5017

Verista’s 600 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:

The ideal candidate will possess a minimum of 5 years of experience in the pharmaceutical or medical device industry, with a proven track record in autoclave (sterilizer), Purified water System, Pure Steam validation.

• Develop, execute, and review comprehensive validation protocols for autoclaves and sterilizers, including Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ).
• Conduct thorough risk assessments to identify potential equipment and process-related risks and implement effective mitigation strategies.
• Collaborate with cross-functional teams, including engineering, production, and quality assurance, to ensure seamless validation execution and compliance.
• Author and maintain detailed validation documentation, including protocols, reports, and deviations.
• Investigate and resolve validation-related deviations and out-of-specification results, implementing corrective and preventive actions (CAPAs) as needed.
• Stay up-to-date with industry regulations and standards (e.g., FDA, EMA, GMP, ISO) to ensure compliance.
• Provide technical expertise and support for autoclave/sterilizer-related inquiries and investigations.
• Participate in continuous improvement initiatives to enhance validation processes and efficiency.
• Maintaining (and ensuring the team maintains) clear, detailed records of qualification and validation, and change control activities for future compliance audits
• Independently understanding client’s quality standards, cGMP’s, and regulatory standards to support team in compliance of validation effort.

Requirements

• Must be willing to work onsite in Houston, TX
• Minimum of 5 years of experience in the pharmaceutical or medical device industry, with a proven track record in autoclave (sterilizer), Purified water System, Pure Steam validation (Must have)
• Bachelor’s Degree or equivalent required
• Proficiency using PC and Microsoft Office tools
• Outgoing personality with strong ability to communicate effectively with peers in clear, concise terms
• Ability to work as part of a team
• 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 (authoring/editing large technical documents with styles, tables, TOCs, track changes)
• Basic skills with EXCEL and PowerPoint
• Strong interpersonal skills and clear communication capabilities
• Experience with and tolerance for high levels of challenge and change.

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

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

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.

$70,491 - $99,533

*Verista is an equal opportunity employer.