Über diese 6498 - Senior CQV Engineer / Senior Validation Engineer Stelle bei Verista, Inc.
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
Senior Validation Engineer Responsibilities:
- Lead and/or support the execution of CQV activities for facilities, utilities, manufacturing equipment, laboratory systems, and computerized systems within GxP-regulated environments.
- Author, review, and execute CQV documentation, including URS, risk assessments, qualification plans, protocols, test scripts, IQ/OQ/PQ documentation, commissioning documents, deviations, and validation/qualification summary reports.
- Develop and execute qualification and testing activities, including IQ/OQ/PQ, functional testing, system walkdowns, field verification, punch-list management, and acceptance testing.
- Coordinate and perform hands-on field execution, ensuring protocols are followed, test results are properly documented, and discrepancies are identified, investigated, and resolved.
- Work with Engineering, Quality, Operations, Automation, and vendors to coordinate commissioning and qualification schedules, test execution, system readiness, and project deliverables.
- Review engineering and vendor documentation, drawings, specifications, manuals, and test records to support CQV planning and execution.
- Ensure CQV deliverables and execution activities comply with cGMP, GAMP 5, ASTM E2500, data integrity principles, and applicable regulatory requirements.
- Manage and support deviations, discrepancies, change controls, and corrective actions associated with commissioning and qualification activities.
- Maintain accurate documentation and ensure all executed records meet Good Documentation Practices (GDP) and client quality requirements.
- Provide technical guidance and mentorship to junior CQV engineers and support the development of standardized CQV processes and templates.
- Communicate project status, risks, issues, and deliverable progress to project and functional leadership.
- Support multiple projects and priorities while maintaining quality, schedule, and execution commitments.
Job Requirements:
- Bachelor’s degree in Engineering, Life Sciences, or a related technical discipline.
- 5+ years of hands-on CQV experience within pharmaceutical, biotechnology, medical device, or other regulated life sciences environments.
- Demonstrated experience with both authoring and field execution of CQV/qualification documentation.
- Strong experience developing and executing IQ/OQ/PQ protocols, commissioning documentation, test scripts, and qualification reports.
- Experience with facilities, utilities, manufacturing equipment, laboratory systems, and/or computerized systems.
- Strong understanding of cGMP requirements and the equipment/system qualification lifecycle.
- Experience with deviation management, change control, punch-list management, and resolution of qualification issues.
- Strong technical writing, documentation, organizational, and problem-solving skills.
- Experience leading CQV activities or workstreams within large pharmaceutical or biotechnology capital projects.
- Experience with GAMP 5, ASTM E2500, risk-based qualification approaches, and data integrity/ALCOA+ principles.
- Experience working with engineering drawings, P&IDs, equipment specifications, and vendor documentation.
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.
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
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
