---
title: 'Senior Manufacturing Engineer at GeneFab'
canonical: 'https://feeny.ai/job/senior-manufacturing-engineer-genefab-alameda-6zbjev6nm675'
type: 'job'
last_seen: '2026-09-11'
---

# Senior Manufacturing Engineer at GeneFab

- **Company:** GeneFab
- **Location:** Alameda, CA
- **Compensation:** $72–$86/hr
- **Employment:** full-time
- **Work type:** onsite
- **Posted:** 2026-04-28
- **Last confirmed live:** 2026-09-11
- **Apply:** https://jobs.lever.co/genefab/6865e1a3-6a39-475d-8f88-0e0d3b6e47eb

## Job description

GeneFab is seeking a Senior Manufacturing Engineer to lead the identification, implementation, and management of production technology and digital infrastructure across our GMP manufacturing operations. This role will serve as the primary driver of GeneFab’s deployment of innovative technologies (internally developed and integration of external) and it’s transition to digital systems (including electronic batch records, process data historians),equipment data integration, and lifecycle management. The Senior Manufacturing Engineer will act as system owner for critical and specialized manufacturing equipment and computerized systems, owning the lifecycle of critical equipment and systems, from acquisition to offboarding. This role will also support commercial readiness activities, contributing to continued process verification infrastructure and regulatory inspection preparedness as GeneFab advances through later-stage clinical and commercial readiness. This is a high-visibility, high-impact individual contributor role. The ideal candidate combines deep GMP manufacturing knowledge with hands-on experience implementing equipment and digital systems in a regulated environment, and thrives in a fast-paced, entrepreneurial setting where they will build and integrate capabilities from the ground up. This position is offered as a contract engagement with eligibility for conversion to full-time employment based on performance, business needs, and mutual alignment. GeneFab is committed to investing in high-performing contributors and views this role as a long-term addition to the organization.

Responsibilities:

- Lead and support design, evaluation, selection and implementation of production technologies and equipment that support highly efficient production of Cell and Gene Therapies.  This includes novel unit operations and process interface equipment, robotics, physical and digital AI, and other related technologies.
- Lead the evaluation, selection, and implementation of an electronic systems such as batch record (EBR) platform to replace paper batch records across all manufacturing processes.
- Establish a process data historian (e.g., AVEVA PI, InfluxDB) to capture and store time-series process and environmental data from manufacturing equipment and cleanroom monitoring systems.
- Develop and execute the equipment data integration strategy, establishing connectivity between GMP instruments (e.g., Miltenyi Prodigy, Cytiva Xuri/XDR/AKTA, Fresenius Kabi Lovo, Sepax, Vi-CELL BLU, NucleoCounter, CryoMed controlled-rate freezers, etc…) and centralized data systems.
- Responsible for equipment and systems end to end; from URS, basis of design/risk assessment, detailed design, implementation, commissioning and qualification.
- Evaluate and deploy integration solutions including OPC-UA connections, data bridge PCs, network file shares, and middleware platforms (e.g., Scitara, Tetra Science) based on instrument connectivity capabilities.
- Ensure all implemented systems comply with 21 CFR Part 11, ALCOA+ data integrity principles, and applicable GAMP 5 guidelines.
- Act as system owner for critical and specialized manufacturing equipment from a data and systems perspective, ensuring equipment data outputs are captured, backed up, and accessible for process monitoring and regulatory purposes.
- Own periodic review cadence, audit trail reviews, user access management, and health monitoring system.
- Manage equipment lifecycle from a systems perspective: lead new equipment implementation and commissioning of data connectivity, oversee system retirement and data archival. Physical maintenance, calibration, and qualification remain with Facilities, Validation, and/or Metrology.
- Own the relationship with digital system and integration middleware vendors, managing contracts, upgrades, issue resolution, and roadmap alignment.
- Develop and maintain system-level documentation including user requirements specifications, system configuration documents, and periodic review reports.
- Build the data infrastructure that enables continued process verification (CPV), ensuring process parameters, quality attributes, and environmental data are consolidated and accessible for statistical trending.
- Partner with MSAT to define data extraction and aggregation workflows from EBR, LIMS, and historian systems to support CPV analysis and reporting.
- Design and implement dashboards and automated reporting tools for real-time manufacturing performance visibility.
- Ensure comprehensive data backup coverage across all instruments, (including those not natively connected to network backup systems such as UniTrends)
- Support commercial readiness activities by ensuring digital systems and data infrastructure are in place to support process validation lifecycle stages, including Stage 3 (continued process verification).
- Contribute to regulatory inspection readiness by maintaining inspection-ready system documentation, audit trails, and access control records.

## Qualifications

- Bachelor’s degree in Engineering (Biomedical, Chemical, Electrical, Mechanical)  , or related field required; advanced degree (M.S. or Ph.D.) preferred.
- Minimum 8+ years of progressive experience in pharmaceutical, biopharmaceutical, or cell/gene therapy manufacturing environments.
- 3+ years of direct experience implementing or managing production technology and digital manufacturing systems such as EBR, LIMS, MES, data historians, or SCADA in a GMP-regulated setting.
- Strong understanding of 21 CFR Part 11, ALCOA+ data integrity principles, GAMP 5 computer system validation, and GMP regulatory expectations for electronic records.
- Hands-on experience with equipment data integration, including familiarity with OPC-UA, APIs, database connectivity, network architecture, and/or middleware platforms.
- Experience serving as a system owner or system administrator for validated computerized systems in a GMP environment.
- Demonstrated ability to work cross-functionally with Manufacturing, Quality, Validation, IT, and Facilities teams.
- Experience in cell therapy, gene therapy, or advanced therapy manufacturing environments preferred.
- Experience with CGT-specific manufacturing equipment required.
- Experience with specific platforms such as (but not limited to) Apprentice.io, MasterControl, PAS-X (EBR), LabVantage, LabWare, or Benchling (LIMS), and/or AVEVA PI or InfluxDB (historian) preferred.
- Experience supporting process validation lifecycle activities, BLA preparation, or regulatory inspection readiness preferred.
- Strong technical writing capability and excellent cross-functional communication and collaboration skills.
- Demonstrated ability to operate with a high degree of independence, define scope, manage competing priorities, and deliver results in a fast-paced, dynamic environment.

## About GeneFab

GeneFab is a contract manufacturing and synthetic biology biofoundry focused on cell and gene therapies. GeneFab was formed in 2023 with a vision to combine industry leading expertise in synthetic biology with advanced cGMP capabilities in order to accelerate the development and commercialization of genetic medicines. GeneFab offers its customers an extensive technology platform and know-how that spans early stage product design, technical development, and cGMP compliant production. GeneFab's technology platform includes bioinformatic-guided discovery of cell type promoters, directed evolution of small molecule-regulated gene switches, and the engineering of highly sensitive kill switches for enhanced safety and control of cellular therapies.

We are committed to an inclusive and diverse GeneFab. We believe that different perspectives lead to better ideas, and better ideas allow us to better understand the needs and interests of our diverse GeneFab team. We welcome people of different backgrounds, experiences, abilities, and perspectives and are an equal opportunity employer.

## About GeneFab

## Company Overview
- **One-liner**: GeneFab is a contract development and manufacturing organization (CDMO) that provides integrated synthetic biology, viral vector production, and cell therapy manufacturing services to innovators in the cell and gene therapy space.
- **Entity Type**: Private (funding stage not publicly available)
- **Headquarters**: Alameda, California, USA (cGMP manufacturing); additionally a SynBio Center of Excellence in South San Francisco, California, USA
- **Founded**: 2023
- **Founders**: Not publicly disclosed; key leadership includes Philip Lee (CEO) and Drew Johnston (President & COO)

## Core Business
- **Primary industry/industries**: Cell and gene therapy CDMO, synthetic biology, viral vector manufacturing, cell therapy contract manufacturing
- **Target customers**: Biotech and pharmaceutical companies developing cell and gene therapies (ex-vivo and in-vivo modalities) – primarily B2B serving innovators from research through commercial supply
- **Mission or purpose statement**: "To make innovative genetic medicines available for all."

## Products & Services
- **Ex Vivo Cell Therapy**: End-to-end autologous and allogeneic workflows covering CAR-T, TCR-T, CAR-NK, Treg, iPSC among others, with multiple expansion platforms tuned to the modality.
- **In Vivo Cell Therapy**: Optimization of genetic elements (e.g., cell-specific promoters) and manufacturing of the lentiviral vector that delivers the therapy directly to patients without an ex-vivo step.
- **Viral Vectors**: Production of lentivirus (LVV) and gamma-retrovirus (GRV) from adherent (2-20 L) to suspension GMP (50-200 L) scale, using stable producer lines.
- **Synthetic Biology**: Proprietary building blocks including cell-specific promoters, kill switches, custom producer cell lines, and ML-driven sequence design.
- **cGMP Manufacturing**: 42,000 sq ft purpose-built cGMP facility in Alameda with seven ISO 7 / Grade B suites, expandable to 92,000 sq ft, meeting FDA & EU GMP standards.
- **QC & Release**: In-house qualified methods running on a regular cadence for phase-appropriate quality release in days.
- **Process Development & Analytics**: Method development, qualification, and transfer; includes genetic circuit design, payload optimization, and analytical assay support.
- **Commercial Readiness & Supply**: Process performance qualification, BLA-readiness, and capacity to scale from clinical lots to commercial demand without changing partners.

## Market Standing
- **Valuation/Market Cap**: Not publicly disclosed
- **Key Metric**: 42,000 sq ft cGMP facility (opened 2023, expandable to 92,000 sq ft) with seven suites; implementing fully electronic quality and document control systems across 2026–2027 for BLA-readiness
- **Notable Investors/Partners**: Not publicly available
- **Growth Signals**: Active hiring via Lever portal (roles include bioprocess specialist, senior manufacturing engineer, program manager, regulatory programs specialist, quality control analyst); leadership team has experience scaling programs from research to commercial supply across multiple modalities

## Competitive Advantages
- **Modality-agnostic design**: Built to handle the full breadth of cell and gene therapy fields – ex-vivo, in-vivo, viral vectors, and synthetic biology – all under one roof.
- **Integrated platform**: Offers one continuous handoff from genetic design and R&D through IND-enabling, clinical, and commercial supply, minimizing vendor handoffs.
- **Co-development approach**: Positions itself as a co-development team with deep innovator-side experience rather than a transactional vendor.
- **New purpose-built facility**: Brand-new 2023 cGMP facility designed specifically for cell and gene therapy, with validated equipment and modern aseptic processing.
- **Leadership track record**: Senior leadership has commercial-scale experience and a clear roadmap to take partner programs through clinical trials and BLA.

## Strategic Focus
- Expanding cGMP manufacturing capacity (future 92K sq ft) to support commercial supply.
- Implementing digital quality systems (2026–2027) to achieve FDA pre-approval inspection readiness.
- Continuing to build a team of scientists, engineers, and operators to support partner programs from early-stage through commercial launch.

## Why Work Here
- **Culture**: Mission-driven environment focused on bringing breakthrough cell and gene therapies to patients. Described as "a team of scientists, engineers, and operators building the CDMO we always wished existed."
- **Work policy**: All listed current openings are on-site in Alameda, CA; some roles operate on 4x10 shift schedules.
- **Growth opportunity**: Join a young CDMO (founded 2023) with ambitions to scale from clinical to commercial supply, offering potential for career advancement as the company expands.
- **State-of-the-art facility**: Work in a new, purpose-built cGMP facility with modern equipment and cleanrooms.
- **Impact**: Directly contribute to the development and manufacturing of life-changing genetic medicines.

## Sources
1. [genefab.com](https://www.genefab.com/)
2. [genefab.com/about](https://www.genefab.com/about.html)
3. [genefab.com/careers](https://www.genefab.com/careers.html)
4. [genefab.com/team](https://www.genefab.com/team.html)
5. [jobs.lever.co/genefab](https://jobs.lever.co/genefab)

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