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
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We think you need these skills to ace 6385- Senior CSV/CQV Engineer / Senior Validation Engineer 2 in Durham
Some tips for your application 🫡
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Emphasise Your Understanding of Regulations:The pharmaceutical industry is heavily regulated, so it's important to indicate your familiarity with industry standards and regulations. In your cover letter, mention any training or certifications you've received that are relevant, or discuss projects where you’ve navigated compliance. This will show Verista that you're not just a fit for the job but also a safety-conscious candidate!
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How to prepare for a job interview at Verista
✨Understand the Science
Make sure you brush up on key pharmaceutical concepts and recent developments in the industry. You might get asked some technical questions during the interview at Verista that show your grasp of drug development processes or regulatory requirements, so be ready to discuss them clearly.
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If you have any hands-on experience or internships in a laboratory setting, be sure to highlight these in your responses. Think about the projects you worked on, the methodologies you used, and the impact you made. It's all about telling a story that connects your background to the role you're applying for.
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In a full-time pharmaceutical role, understanding the regulatory landscape is crucial. Prepare for situational questions that may test your problem-solving skills concerning compliance and safety standards. You could be asked how you'd handle a hypothetical issue regarding a drug’s market release, so think through your approach.
