6111 - CQV Engineer / Validation Engineer
About The Position
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 Job Overview: The Validation Engineer will play a critical role in the successful startup and qualification of a new early-phase clinical manufacturing facility, encompassing cleanrooms, utilities, and a wide range of systems and equipment. This position is responsible for generating and executing commissioning and qualification protocols and producing summary reports.
Requirements
- Bachelor’s degree in engineering, Life Sciences, or a related field
- 2+ years of relevant experience in validation within a regulated industry (e.g., pharma, biotech)
- Experience working in a cGMP environment and following Good Documentation Practices
- Knowledge of cGMP, FDA, and other regulatory guidelines
- Experience with facility, utility, equipment, and computer system validation (preferably in early-phase clinical manufacturing facilities)
- Excellent documentation, analytical, and problem-solving skills
- Ability to work well independently as well as part of a team
Responsibilities
- Develop and execute commissioning and qualification protocols for facilities, utilities and equipment in compliance with project timelines and regulatory requirements with support of senior engineers
- Perform field execution of commissioning and qualification protocols, ensuring accurate data collection and adhering to procedures
- Collaborate with cross-functional teams (QA, Facilities, Manufacturing) to support validation activities
- Maintain accurate documentation and prepare summary reports
- Identify and resolve deviations and non-conformances during qualification activities, implementing corrective actions as needed
- Ensure proper documentation and traceability for all qualification activities to support audits and inspections
Benefits
- 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
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What This Job Offers
Job Type
Full-time
Career Level
Mid Level
Number of Employees
501-1,000 employees
