At a Glance
- Tasks: Support validation of process equipment and ensure data integrity in life sciences.
- Company: Join Verista, a leader in empowering growth within the scientific community.
- Benefits: Competitive pay, health insurance, 401(k) matching, and tuition reimbursement.
- Other info: Dynamic team culture with high growth potential and fun social activities.
- Why this job: Make a real impact on healthcare challenges while working with top brands.
- Qualifications: Bachelor's degree and 5 years of CSV experience in GMP environments.
The predicted salary is between 65000 - 90817 £ per year.
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
Position Summary
The CSV/CQV Engineer will support the commissioning, qualification, and validation of process equipment, utilities, facilities, and PAT systems. This role is responsible for all computerized system validation (CSV) and data integrity (DI) activities, working under the direction of the Validation Lead and alongside the CQV team.
General CSV Skills
- Familiarity with global standards for computerized systems and data integrity.
- Ability to classify systems as “simple” or “complex” using risk‑based criteria to right‑size validation effort.
- Experience authoring CSV deliverables: URS/FDS/DDS review, risk assessments, test protocols (IQ/OQ), and summary reports.
- Supplier assessment execution for OEM‑provided computerized systems.
- Data integrity assessment using ALCOA+ principles, including audit trail, user roles, time sync (NTP), backup/restore, and archival.
Project‑Specific CSV Responsibilities
- Author Data Integrity Assessments for each Direct Impact computerized system, defining roles/privileges, and confirming electronic records handling.
- Assess and document how PAT result data integrates with the paper‑based manufacturing batch record (MBR) interface, ensuring data integrity at the point of data transfer.
- Perform supplier assessments for major OEM systems and PAT instruments.
- Author configuration specifications for computerized systems where client templates are available or where vendor documentation is insufficient.
- Write CSV sections within IQ/OQ protocols – access control, audit trail verification, time sync (NTP), backup/restore, and data flow tests.
- Develop data flow diagrams for critical integrations.
- Execute IQ/OQ CSV test scripts, including; User role and access control, Audit trail review, Time synchronization, Backup and restore, and Data flow and accuracy.
- Document any deviations discovered during CSV testing, perform impact assessment, and track CAPAs to closure.
Required Qualifications
- Bachelor’s degree in engineering, computer science, or related field.
- Minimum 5 years of CSV experience in GMP pharmaceutical or biotech environments.
- Proven experience with equipment‑level PLC/HMI validation (OEM systems) and historian connectivity.
- Hands‑on experience with PAT instrument integration (e.g., NIR, moisture analyzers) is a strong plus.
- Must be local in or around RTP, must be able to work on site 100%.
Benefits
- 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
6385- Senior CSV/CQV Engineer / Senior Validation Engineer 2 in Durham employer: Verista
Verista is an exceptional employer that prioritises the growth and well-being of its employees, offering a dynamic work environment in the heart of the RTP area. With a strong commitment to professional development, competitive compensation, and a culture that fosters collaboration and inclusivity, Verista empowers its team to make a meaningful impact in the life sciences sector. Employees enjoy comprehensive benefits, including generous paid time off, tuition reimbursement, and various health insurance options, all while being part of a vibrant community dedicated to innovation and client success.
StudySmarter Expert Advice🤫
We think this is how you could land 6385- Senior CSV/CQV Engineer / Senior Validation Engineer 2 in Durham
✨Tip Number 1
Network like a pro! Reach out to your connections in the life sciences field and let them know you're on the hunt for a Senior CSV/CQV Engineer role. You never know who might have the inside scoop on job openings or can put in a good word for you.
✨Tip Number 2
Prepare for interviews by brushing up on your knowledge of global standards for computerized systems and data integrity. Be ready to discuss your experience with risk assessments and test protocols, as these are key topics that will likely come up during your chats with potential employers.
✨Tip Number 3
Showcase your hands-on experience! If you've worked with PAT instruments or have done supplier assessments, make sure to highlight these in your conversations. Real-world examples can set you apart from other candidates.
✨Tip Number 4
Don't forget to apply through our website! It’s the best way to ensure your application gets noticed. Plus, we love seeing candidates who are proactive about their job search and genuinely interested in joining our team at Verista.
We think you need these skills to ace 6385- Senior CSV/CQV Engineer / Senior Validation Engineer 2 in Durham
Some tips for your application 🫡
Tailor Your CV:Make sure your CV is tailored to the Senior CSV/CQV Engineer role. Highlight your relevant experience in computerized system validation and data integrity, and don’t forget to mention any specific projects that align with what we do at Verista.
Craft a Compelling Cover Letter:Your cover letter is your chance to shine! Use it to explain why you’re passionate about life sciences and how your skills can help us empower growth and innovation. Keep it engaging and personal – we want to see your personality!
Showcase Your Team Spirit:At Verista, we thrive in a team environment. In your application, share examples of how you’ve collaborated with others in past roles. This will show us that you’re not just a great engineer, but also a fantastic teammate!
Apply Through Our Website:We encourage you to apply directly through our website. It’s the best way to ensure your application gets into the right hands. Plus, you’ll find all the details about the role and our company culture there!
How to prepare for a job interview at Verista
✨Know Your CSV Inside Out
Make sure you brush up on your knowledge of computerized system validation (CSV) and data integrity principles. Be ready to discuss your experience with URS/FDS/DDS reviews, risk assessments, and test protocols. This will show that you’re not just familiar with the concepts but can apply them effectively.
✨Showcase Your Team Spirit
Verista values collaboration and teamwork, so be prepared to share examples of how you've worked successfully in a team environment. Highlight any experiences where you empowered colleagues or contributed to client success, as this aligns perfectly with their company culture.
✨Prepare for Technical Questions
Expect technical questions related to PAT systems and equipment-level PLC/HMI validation. Brush up on your hands-on experience with PAT instrument integration and be ready to discuss specific projects where you’ve executed IQ/OQ CSV test scripts. This will demonstrate your practical expertise.
✨Ask Insightful Questions
At the end of the interview, don’t forget to ask questions that show your interest in Verista’s mission and values. Inquire about their approach to continuous learning and skill acquisition, or how they support an inclusive environment. This will reflect your alignment with their culture and commitment to growth.
