Verista, Inc.
6245 - Solution Prep Principal CQV Engineer / Lead Validation Engineer
Apex, NC · Principal
Sponsorship not specified$108k-$168kDetected 62 days ago
Customer SupportGMPCell CultureCommunication
About the role
- 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 talented and dedicated professionals are committed to making an impact every day.
- Experience working within digital validation platforms such as Kneat is highly desirable.
Responsibilities
- Support commissioning, qualification, and validation (CQV) activities for solution preparation systems used in biopharmaceutical manufacturing.
- Solution Preparation Process Support
- Support equipment startup and operational readiness for solution preparation processes.
- Support Factory Acceptance Testing (FAT) and Site Acceptance Testing (SAT) for new equipment.
- Coordinate with equipment vendors and system integrators to ensure systems are installed and functioning according to design specifications.
- Collaborate with engineering, automation, quality assurance, and manufacturing teams to align project deliverables.
- Utilize electronic validation platforms (e.g., Kneat) to develop, manage, and execute validation documentation.
- Maintain data integrity, traceability, and compliance within digital validation systems.
Requirements
- Bachelor's degree in Engineering, Biotechnology, Life Sciences, or related technical field
- 10+ years of role specific experience
- Experience supporting CQV activities within GMP-regulated pharmaceutical or biotechnology environments
- Hands-on experience with solution preparation, buffer prep, or media prep systems
- Strong understanding of CQV lifecycle documentation (IQ/OQ/PQ protocols and reports)
- Ability to work independently while coordinating with cross-functional teams
- Experience using digital validation platforms such as Kneat
- Experience supporting FAT/SAT, commissioning, and equipment startup
- Familiarity with single-use systems and biologics manufacturing processes
- Experience working within biologics or cell culture manufacturing facilities
Nice to have
- Competitive pay plus performance-based incentive programs
Compensation
- For US geography, the salary range for this position is shown below.
Benefits
- Company-paid Life, Short-Term, and Long-Term Disability Insurance.
- Medical, Dental & Vision insurances
- FSA, DCARE, Commuter Benefits
- Health Savings Account
- 401(k) Retirement Plan (Employer Matching benefit)
- Paid Time Off (Rollover Option) and Holidays
- Tuition Reimbursement
- Paid Parental Leave and Bereavement
Company info
- 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
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