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Verista · 1 month ago

6047 - Senior CQV Engineer / Senior Validation Engineer

Thousand Oaks, CA

Full-time

Onsite

Senior Level

$70K/yr - $118K/yr

5+ years exp

Verista is a company that teams up with recognized brands in the life science industry to address business needs and empower growth. The Senior CQV Engineer will be responsible for the planning, execution, and documentation of commissioning, qualification, and validation activities for a new early-phase clinical biomanufacturing facility, ensuring compliance with regulatory standards.

ComplianceHealth CareLife ScienceManufacturingPharmaceutical

H1B Sponsor Likely

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

Qualification

Validation principlesCGMP knowledgeFDA regulationsAnalytical skillsTechnical documentationProblem-solving skillsTeam collaborationIndependent work

Required

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

Benefits

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

Company

Verista

Verista offers transformative compliance, automation, packaging solutions for the life sciences, pharmaceutical and manufacturing.

Founded in 1983

Fishers, Indiana, USA

501-1000 employees

https://www.verista.com/

H1B Sponsorship

Verista has a track record of offering H1B sponsorships. Please note that this does not guarantee sponsorship for this specific role. Below presents additional info for your reference. (Data Powered by US Department of Labor)

Distribution of Different Job Fields Receiving Sponsorship

Represents job field similar to this job

Trends of Total Sponsorships

2025 (7)

2024 (4)

2023 (13)

2022 (6)

2021 (1)