Senior CQV Engineer​/Senior Validation Engineer

Job Overview

Senior CQV Engineer will play a critical role in the successful startup and qualification of a new early‑phase clinical biomanufacturing facility, encompassing clean rooms 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.

• 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.

• 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

National (US) Range: $70,491 – $118,062 USD

• 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
• Supplemental Life, Hospital, Critical Illness and Legal Insurance
• Health Savings Account
• 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.