Verista
6047 - Senior CQV Engineer / Senior Validation Engineer
Verista, Thousand Oaks, California, United States, 91362
Company Overview
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 Senior CQV Engineer will play a critical role in the successful startup and qualification of a new early‑phase clinical biomanufacturing facility, encompassing cleanrooms, utilities, and a wide range of systems and equipment. This position is responsible for planning, executing, and documenting commissioning, qualification, and validation (CQV) activities to ensure all systems meet stringent regulatory and client‑specific requirements.
Senior CQV Engineer Responsibilities
Authoring, editing, and executing technical commissioning, qualification and validation documentation for facilities, utilities, and standard equipment/systems/software
Actively consulting clients on regulatory validation processes and standard industry acceptable practices
Collaborating with cross‑functional teams including Manufacturing, Facilities, Quality Control and Quality Assurance to ensure validation activities are properly scoped and executed
Taking independent leadership role on project(s)
Managing and working collaboratively with clients’ quality representative to complete deviation investigation and resolution for problems and issues encountered during execution activities—including ability to complete root cause analysis
Job Qualifications
Bachelor’s degree in engineering, Life Sciences, or a related field
5+ years of relevant experience in validation within a regulated industry (e.g., pharma, biotech)
Experience with facility, utility, equipment, and computer system validation, preferably in start‑up of early‑phase clinical biomanufacturing facilities
Strong knowledge of validation principles, cGMP, FDA regulations (21 CFR Part 11, Part 210/211), and industry guidelines (e.g., ISPE, GAMP)
Experience working with start‑up clients, without well established company procedures and standards
Excellent documentation, analytical, and problem‑solving skills
Ability to work independently and as part of a team
Salary National (US) Range: $70,491 USD - $130,000 USD
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 is an equal opportunity employer.
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
#J-18808-Ljbffr
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 Senior CQV Engineer will play a critical role in the successful startup and qualification of a new early‑phase clinical biomanufacturing facility, encompassing cleanrooms, utilities, and a wide range of systems and equipment. This position is responsible for planning, executing, and documenting commissioning, qualification, and validation (CQV) activities to ensure all systems meet stringent regulatory and client‑specific requirements.
Senior CQV Engineer Responsibilities
Authoring, editing, and executing technical commissioning, qualification and validation documentation for facilities, utilities, and standard equipment/systems/software
Actively consulting clients on regulatory validation processes and standard industry acceptable practices
Collaborating with cross‑functional teams including Manufacturing, Facilities, Quality Control and Quality Assurance to ensure validation activities are properly scoped and executed
Taking independent leadership role on project(s)
Managing and working collaboratively with clients’ quality representative to complete deviation investigation and resolution for problems and issues encountered during execution activities—including ability to complete root cause analysis
Job Qualifications
Bachelor’s degree in engineering, Life Sciences, or a related field
5+ years of relevant experience in validation within a regulated industry (e.g., pharma, biotech)
Experience with facility, utility, equipment, and computer system validation, preferably in start‑up of early‑phase clinical biomanufacturing facilities
Strong knowledge of validation principles, cGMP, FDA regulations (21 CFR Part 11, Part 210/211), and industry guidelines (e.g., ISPE, GAMP)
Experience working with start‑up clients, without well established company procedures and standards
Excellent documentation, analytical, and problem‑solving skills
Ability to work independently and as part of a team
Salary National (US) Range: $70,491 USD - $130,000 USD
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 is an equal opportunity employer.
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
#J-18808-Ljbffr