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Senior Process Development Engineer Jobs in Pleasanton, CA

GeneFab

Senior Process Engineer, MSAT

Alameda, CA · On-site

$117K - $152K/yr

The Senior Process Engineer will translate scientific insight into robust manufacturing processes ... Collaborate closely with Process Development to evaluate platform candidates, align on scalable ...

GeneFab

Senior Process Engineer, MSAT

Alameda, CA

$117K - $152K/yr

The Senior Process Engineer will translate scientific insight into robust manufacturing processes ... Collaborate closely with Process Development to evaluate platform candidates, align on scalable ...

Micross

Senior Process Engineer

Milpitas, CA · On-site

$100K - $135K/yr

The Senior Process Engineer will perform IC Assembly process development and improvement directly resulting in increased efficiency and quality on the production floor . This will be achieved through ...

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All JobsProcess Development Engineer JobsSenior Process Development Engineer JobsSenior Process Development Engineer Jobs in Pleasanton, CA

Senior Process Development Engineer information

See Pleasanton, CA salary details

$83.5K

$134.8K

$189.8K

How much do senior process development engineer jobs pay per year?

As of Aug 17, 2026, the average yearly pay for senior process development engineer in Pleasanton, CA is $134,790.00, according to ZipRecruiter salary data. Most workers in this role earn between $115,700.00 and $149,700.00 per year, depending on experience, location, and employer.

What does a senior process development engineer do?

A Senior Process Development Engineer is responsible for designing, developing, and optimizing manufacturing processes to improve efficiency, quality, and cost-effectiveness. They often lead teams in scaling up processes from the laboratory to full production, troubleshoot technical issues, and implement new technologies or methods. Additionally, they collaborate with cross-functional teams, including R&D, quality assurance, and production, to ensure processes meet regulatory and safety standards. Their expertise helps companies maintain competitive advantages and meet production goals.

What are the key skills and qualifications needed to thrive as a senior process development engineer?

To thrive as a Senior Process Development Engineer, you need a strong background in chemical or mechanical engineering, process optimization, and project management, typically supported by a relevant engineering degree. Familiarity with CAD software, process simulation tools (such as Aspen Plus or MATLAB), and Six Sigma or Lean Manufacturing certifications is often required. Excellent problem-solving, leadership, and communication skills help you coordinate cross-functional teams and drive continuous improvement. These skills are crucial for developing efficient, scalable processes that meet quality standards and business goals.

What are some common challenges a senior process development engineer may face when scaling up a new process from the lab to full production?

Senior Process Development Engineers often encounter challenges such as maintaining product quality and consistency when transitioning from small-scale laboratory experiments to large-scale manufacturing. This process typically involves troubleshooting equipment limitations, optimizing process parameters, and ensuring compliance with safety and regulatory standards. Effective collaboration with cross-functional teams, such as R&D, manufacturing, and quality assurance, is crucial to address these challenges and achieve a smooth scale-up. Adaptability and problem-solving skills are essential to navigate unexpected issues that may arise during this transition.

What is the difference between Senior Process Development Engineer vs Process Engineer?

AspectSenior Process Development EngineerProcess Engineer
CredentialsBachelor's or Master's in Chemical, Mechanical, or Industrial Engineering; experience in process developmentBachelor's degree in Engineering or related field; entry to mid-level experience
Work EnvironmentResearch and development labs, manufacturing facilities, cross-functional teamsManufacturing plants, production lines, process optimization teams
Industry UsagePharmaceuticals, chemicals, biotech, manufacturingManufacturing, chemical processing, consumer goods

The main difference is that Senior Process Development Engineers focus on developing and optimizing new processes, often in R&D settings, while Process Engineers typically oversee existing manufacturing processes to improve efficiency and quality. Senior roles involve more strategic planning and innovation, whereas Process Engineers focus on day-to-day process operations.

What are popular job titles related to Senior Process Development Engineer jobs in Pleasanton, CA?

For Senior Process Development Engineer jobs in Pleasanton, CA, the most frequently searched job titles are:

What job categories do people searching Senior Process Development Engineer jobs in Pleasanton, CA look for?

The top searched job categories for Senior Process Development Engineer jobs in Pleasanton, CA are:

What cities near Pleasanton, CA are hiring for Senior Process Development Engineer jobs?

Cities near Pleasanton, CA with the most Senior Process Development Engineer job openings:

Senior Process Development Engineer jobs near you
Infographic showing various Senior Process Development Engineer job openings in Pleasanton, CA as of August 2026, with employment types broken down into 1% As Needed, 78% Full Time, 19% Part Time, and 2% Contract. Highlights an 89% Physical, 3% Hybrid, and 8% Remote job distribution, with an average salary of $134,790 per year, or $64.8 per hour.

Senior Process Engineer, MSAT

GeneFab

Alameda, CA • On-site

$117K - $152K/yr

Full-time

Re-posted 22 days ago

Job description

GeneFab is seeking a highly motivated and technically accomplished Senior Process Engineer, MSAT to serve as a critical technical authority within our Cell and Gene Therapy CDMO. This individual will drive the establishment and maturation of GMP-ready platform processes that form the foundation of our internal manufacturing capabilities, operating with a high degree of autonomy across complex, cross-functional initiatives spanning process development, technology transfer, CMC strategy, and capability buildout.
This role is pivotal in shaping GeneFab's ability to deliver scalable, regulatory-compliant manufacturing platforms that clients can leverage directly in their IND filings and beyond. The Senior Process Engineer will translate scientific insight into robust manufacturing processes while building the infrastructure, capability, and frameworks necessary to support GMP operations at scale. The ideal candidate thrives in a fast-paced, entrepreneurial environment, is energized by building capabilities from the ground up, and brings the independent judgment to drive programs forward.
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.
Requirements
  • Lead the GMP implementation of internal platform processes for cell and gene therapy modalities, including upstream and downstream unit operations.
  • Collaborate closely with Process Development to evaluate platform candidates, align on scalable manufacturing approaches, and ensure all platforms are structured to support CMC regulatory expectations for regulatory filings.
  • Serve as a technical lead for technology transfer, validation, and lifecycle management initiatives.
  • Contribute to CMC regulatory submissions by authoring and reviewing CMC module 3 sections, development summaries, and supporting data packages for applicable regulatory filings.
  • Apply deep CMC knowledge to ensure internal platform processes align with current regulatory guidance (FDA, EMA, ICH Q8/Q9/Q10/Q11/Q12) and support the development of CMC content strategies.
  • Serve as an MSAT lead for advanced technology transfer activities, including transfers from external clients and inbound transfers from internal process development groups.
  • Develop and execute comprehensive tech transfer plans including process descriptions, batch records, comparability strategies, and acceptance criteria.
  • Lead the identification, evaluation, procurement, and implementation of GMP manufacturing equipment required to enable platform capabilities and enhance existing capabilities.
  • Author, review, and approve SOPs, work instructions, master batch records, and other GMP-controlled documents for processes and associated equipment.
  • Provide technical oversight during engineering and GMP manufacturing runs to evaluate process reproducibility, identify performance gaps, and drive data-driven continuous improvement initiatives.
  • Function as the MSAT subject matter expert (SME) across cross-functional teams spanning Process Development, Quality, Regulatory and Manufacturing.
  • Provide technical mentorship and guidance to junior MSAT engineers and manufacturing specialists; develop and deliver training materials for platform processes, equipment, necessary systems.
  • Own, drive, and support quality management records, including but not limited to deviations, CAPAs, change controls, SCARs and effectiveness checks.

Qualifications
  • Bachelor's degree in Chemical Engineering, Biochemical Engineering, Bioprocess Engineering, or a closely related life sciences field required; advanced degree (M.S. or Ph.D.) strongly preferred.
  • Minimum 6-8+ years of progressive experience in bioprocess development, MSAT, or GMP manufacturing within the biopharmaceutical or cell and gene therapy industry, commensurate with degree level.
  • Demonstrated expertise in advanced technology transfer, including hands-on leadership of complex tech transfer programs from process development through GMP manufacturing; CDMO or CMO experience highly preferred.
  • Experience in cell therapy (CAR-T, TIL, NK, or similar), gene therapy (AAV, lentiviral, or other viral vectors), or adjacent CGT modalities is highly preferred.
  • Experience supporting IND, IMPD, or BLA filings with the ability to author and critically review CMC sections of regulatory submissions, working knowledge of ICH Q8, Q9, Q10, Q11, and Q12 guidelines.
  • Deep understanding of GMP regulations (21 CFR Parts 210/211/600/610, EU GMP Annex 1/15) as applied to advanced therapy manufacturing; strong command of GMP documentation practices including SOP authorship, batch record design, deviation management, and CAPA.
  • Working knowledge of process characterization, design of experiments (DoE), and data-driven process optimization methodologies; familiarity with analytical methods used to characterize cell and gene therapy products (i.e. identity, potency, purity, safety testing).
  • Demonstrated ability to operate with a high degree of independence, define scope, manage competing priorities, and deliver results in a fast-paced, dynamic environment.
  • Strong technical writing capability with experience authoring SOPs, batch records, validation protocols, deviation reports, and regulatory submission content; excellent cross-functional communication and collaboration skills.

$72 - $89 an hour
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.
We may use artificial intelligence (AI) tools to support parts of the hiring process, such as reviewing applications, analyzing resumes, or assessing responses and identifying potential inconsistencies or verification signals in application materials based on available information. These tools assist our recruitment team but do not replace human judgment. Final hiring decisions are ultimately made by humans. If you would like more information about how your data is processed, please contact us.

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