Job Information
Verista Senior CQV Engineer / Senior Validation Engineer- 5017 in Houston, Texas
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 (https://apply.workable.com/verista/)
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.