Cell & Gene Therapy SME​/Lead Process Engineer

6068 - Cell & Gene Therapy SME / Lead Process Engineer

Join to apply for the 6068 - Cell & Gene Therapy SME / Lead Process Engineer role at Verista.

Verista’s 500 experts team up with the world’s most recognizable brands in the life science industry to solve their business needs. Our mission is to empower growth and innovation within the scientific community and help researchers, organizations, and companies solve some of the world’s most pressing healthcare challenges.

• 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

• Lead end‑to‑end process validation activities for cell and gene therapy manufacturing, including qualification of equipment, cleaning, and analytical methods.
• Develop and execute validation protocols (IQ/OQ/PQ) and maintain validation master plans for cell & gene therapy processes.
• Ensure compliance with FDA, EMA, and ICH guidelines, as well as cGMP/cGTP requirements.
• Review regulatory documentation for IND, BLA, and other submissions and provide recommendations for highly manual processes.
• Monitor changes in global regulatory requirements and implement updates in SOPs and cell therapy processes.
• Provide cell therapy technical expertise during risk assessments and CAPA implementation.
• Train cross‑functional teams on cell therapy validation and compliance best practices.
• Support technology transfer and scale‑up activities with a focus on regulatory alignment.

• Bachelor’s or Master’s degree in Biotechnology, Pharmaceutical Sciences, or related field.
• 5+ years of experience in process validation within cell/gene therapy or biologics manufacturing.
• In‑depth knowledge of cGMP/cGTP, FDA, EMA, and ICH regulatory frameworks.
• Strong experience with validation protocols, regulatory submissions, and audit readiness.
• Excellent communication and leadership skills to influence cross‑functional teams.

National (US) Range: $85,000 USD – $150,000 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.
• 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
• 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