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Verista · 4 days ago

6068 - Cell & Gene Therapy SME / Lead Process Engineer

Berkeley, CA

Full-time

Onsite

Senior Level, Lead/Staff

$85K/yr - $150K/yr

5+ years exp

Verista is a company that empowers growth and innovation within the scientific community to address healthcare challenges. The Cell & Gene Therapy SME / Lead Process Engineer will serve as the subject matter expert for process validation and regulatory compliance in cell and gene therapy manufacturing, ensuring all processes meet global regulatory standards.

ComplianceHealth CareLife ScienceManufacturingPharmaceutical

H1B Sponsor Likely

Responsibilities

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 requirements on 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

Qualification

Process validationCGMP/cGTP complianceRegulatory submissionsBiologics manufacturingValidation protocolsLeadership skillsCommunication skills

Required

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

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

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)