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Added 3 mins ago
Process Engineer II/III - API (Recovery) Mon-Fri shift
Clayton
Experience with Process Control Systems preferred
Added 7 mins ago
Manager, Software Development Engineer
Equinix LLC
United States
Equinix is looking for a Manager, Software Engineer to lead the team that builds and supports our channel and partner systems. The platforms include Salesforce Partner Relationship…
Added 7 mins ago
T
Firmware Architect/Product Security Technical Lead
TEKsystems
Richardson, TX
- $70 to $87 USD / hour
…boot, authentication, cryptography, key management, access control, secure communications, logging, and secure update…
Added 8 mins ago
Fluids Engineer II - Glenn Stage 2 Mid/Fwd
Blue Origin Personnel, LLC
United States
Added 8 mins ago
Cable Fabrication Technician II
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Pasadena, CA
This unique opportunity is part of the Mechanical & Control Systems Division which engages in research, technology development, and the creation of advanced mechanical, thermal, propulsion,…
Added 10 mins ago
Software Dev Engineer II, Checkout Platform
Amazon.com Services LLC
Seattle, WA
The Amazon Checkout Platform team seeks a creative software development engineer who treats software development as a craft, cares deeply about our customers, and takes great pride in both…
Added 14 mins ago
Automation Engineer I/II - Discovery Oncology
Eli Lilly and Company
United States
We're looking for an Automation Engineer I/II to help build, operate, and maintain the automated systems that power our laboratory workflows. You'll work alongside a senior Lab Automation…
Added 16 mins ago
Quality Engineer/Principal Quality Engineer 2/3
CORP-Corporate Office
United States
Specialize as needed in design, incoming material, production control, product evaluation, reliability, inventory control, or R&D as they apply to product or process quality.
Added 17 mins ago
Manufacturing Engineer
Intuitive
Sunnyvale, CA
…order to refine electro-mechanical components, assemblies, process documentation, tooling and test methods to improve efficacy, reliability, manufacturability and cost for surgical robotic…
Added 18 mins ago
Process Engineer (Corpus Christi, TX)
The Planet Group
Corpus Christi, TX
A leading organization in the energy and industrial infrastructure sector is seeking a Process Engineer II to support operations at a large-scale terminal and storage facility along the…
Added 22 mins ago
Protection and Control Engineer II
Electric Power Engineers
Austin, TX
Process, generate and maintain data as required for other engineering-related work
Added 23 mins ago
Software Engineer - Connected Vehicle Data
Stellantis
Auburn Hills, MI
We're looking for an experienced engineer who knows connected vehicles well and has a track record of getting technical projects delivered. You'll lead work from the first requirements…
Added 24 mins ago
Senior FPGA Engineer II
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Long Beach, CA
We are currently seeking a Sr. FPGA Engineer II for a future opening to join our FPGA team based out of Long Beach, CA. This team supports our Space Systems division, and leads cutting-edge…
Added 24 mins ago
Field Welding Engineer / NDE Coordinator
Bechtel Corporation
Thacker Pass, NV
Planned with sustainability and the environment in mind, the facility will use its excess process heat to generate electricity and will recycle process water up to seven times. Once the…
Added 25 mins ago
New Graduate Engineer, Mechanical - Satellites (Starlink)
SpaceX
Redmond, WA
Experience with design of experiments, statistical process control, and process qualification.
Added 25 mins ago
New Graduate Engineer, Electrical - Satellites (Starlink)
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Redmond, WA
As an Electrical Design Engineer on Starlink, you’ll have ownership over the entire life-cycle of the hardware that enables this connectivity, and sits at the intersection of electrical,…
Added 26 mins ago
Systems Engineer II
Sierra Nevada Corporation
Lone Tree, CO
…and sustain our way of living. Join our team! As a Systems Engineer II, you will build upon foundational skills and perform intermediate tasks in requirements engineering, systems…
Added 1 hour ago
Manufacturing RF Product Engineer II
Aerospace
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In this role Manufacturing RF Product Engineer supports MMIC products across post-production and development phases, including wafer probe, packaging, and final RF test. This role focuses…
Added 1 hour ago
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Quality Engineer III
Kent, WA
- $77,968 to $130,228 USD / year
Hexcel is currently seeking a Quality Engineer III for our Kent, WA location.
Added 1 hour ago
Senior Software Engineer II, Cloud Security
Qualia
Austin, TX · Concord, NH · San Francisco, CA
…and selling experience into a simple, secure, and enjoyable process. Our SMB and Enterprise products bring together users from across the real estate ecosystem - homebuyers and sellers,…
Added 1 hour ago
Cyber Security Engineer
INSPYR Solutions
Vienna, VA
Seeking a Cybersecurity Engineer to support enterprise application control, endpoint security, and Microsoft Defender technologies. This role will focus on implementing and troubleshooting…
Added 2 hours ago
Software Development Engineer, ADC2S
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Denver, CO
Amazon Web Services (AWS) is looking for a Software Development Engineer II to design, build, and operate Amazon Elastic Compute Cloud (EC2) control-plane services in air-gapped regions.…
Added 2 hours ago
Wet Etch Equipment Engineer, Solar Cells (Starlink)
SpaceX
Bastrop, TX
As a Wet Etch Equipment Engineer you will own the chemical processing equipment (wet chemical texturing tools, wet chemical preclean tools) used to manufacture silicon heterojunction solar…
Added 2 hours ago
Equipment Engineer, Wet Process (Solar Cells)
SpaceX
Bastrop, TX
As an Equipment Engineer, Wet Process you will own the chemical processing equipment (wet chemical texturing tools, wet chemical preclean tools) used to manufacture silicon heterojunction…
Added 2 hours ago
Equipment Engineer, Solar Cell Metallization (Starlink)
SpaceX
Bastrop, TX
As a Equipment Engineer, Solar Cell Metallization, you will own the screen printing and related metallization equipment used to manufacture silicon heterojunction solar cells at massive…

Intuitive

Senior QC Engineer, CMC / GMP QA

Sunnyvale, CA, United States

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Job details

Experience: Minimum of 10 years of experience in pharmaceutical or biotechnology CMC, GMP, or Quality roles
Posting language: English
Posted: Nov 4, 2026

Original job description

Company Description It started with a simple idea: what if surgery could be less invasive and recovery less painful? Nearly 30 years later, that question still fuels everything we do at Intuitive. As a global leader in robotic-assisted surgery and minimally invasive care, our technologies like the da Vinci surgical system and Ion have transformed how care is delivered for millions of patients worldwide. Were a team of engineers, clinicians, and innovators united by one purpose: to make surgery smarter, safer, and more human. Every day, our work helps care teams perform with greater precision and patients recover faster, improving outcomes around the world. The problems we solve demand creativity, rigor, and collaboration. The work is challenging, but deeply meaningful because every improvement we make has the potential to change a life. The Future Forward organization is Intuitive’s advanced concepts group. We explore emerging technologies, prototype next-generation solutions, and build software experiences that shape the future of robotic-assisted surgery. If you're ready to contribute to something bigger than yourself and help transform the future of healthcare, you'll find your purpose here.

Job Description

The Senior Consultant, CMC / GMP Documentation & Quality Control provides long-term, hands-on expert support primarily focused on CMC and GMP documentation review, with additional support for Quality Control (QC) activities related to technology transfer, for an early- to late-stage pharmaceutical development organization.

This role serves as a senior subject matter expert embedded within CMC and Quality teams, supporting sustained development, regulatory readiness, and inspection preparedness through detailed review, quality assessment, and remediation of CMC and GMP documentation. QC support is primarily documentation- and review-focused, with limited hands-on involvement in technical transfer activities as needed. This is a long-term consulting role with no people-management responsibilities.

Key Responsibilities

Perform detailed quality review of CMC documentation including specifications, batch records, validation documentation, stability protocols and reports, and technical reports
Review GMP documentation for compliance with FDA, EMA, ICH, and other applicable global regulatory requirements
Identify documentation gaps, inconsistencies, and compliance risks and recommend corrective actions
Support QC documentation review activities related to analytical methods, test records, and data packages
Provide QC documentation and quality review support for technology transfer activities, as needed
Support investigations related to QC deviations, OOS/OOT results, and documentation discrepancies
Support inspection readiness by ensuring CMC and GMP documentation is inspection-ready, accurate, and complete
Assist with responses to regulatory questions, inspection observations, and information requests related to CMC and QC topics
Review CMC and GMP documentation generated by CDMOs, testing laboratories, and other external partners
Provide clear, practical documentation feedback to vendors to drive compliance and quality improvements
Collaborate closely with CMC, QA, Regulatory Affairs, and external partners

Qualifications

Required:

Bachelor’s degree in Chemistry, Engineering, Life Sciences, or related discipline (advanced degree preferred)
Minimum of 10 years of experience in pharmaceutical or biotechnology CMC, GMP, or Quality roles
Strong hands-on experience reviewing CMC and GMP documentation
Working knowledge of GMP requirements applicable to drug substance and drug product development
Experience supporting QC documentation, investigations, and data integrity requirements
Demonstrated ability to identify documentation gaps and drive corrective actions

Preferred:

Experience supporting early-stage through late-stage development programs
Experience working with CDMOs and external testing laboratories
Experience supporting technology transfer documentation or QC readiness activities
Experience supporting regulatory inspections or agency interactions
Familiarity with electronic document management systems and QMS platforms Additional Information Mandatory Notices We will consider for employment qualified applicants with arrest and conviction records in accordance with fair chance laws. Preference will be given to qualified candidates who do not reside, or plan to reside, in Alabama, Arkansas, Delaware, Florida, Indiana, Iowa, Louisiana, Maryland, Mississippi, Missouri, Oklahoma, Pennsylvania, South Carolina, or Tennessee. We provide market-competitive compensation packages, inclusive of base pay, incentives, benefits, and equity. It would not be typical for someone to be hired at the top end of range for the role, as actual pay will be determined based on several factors, including experience, skills, and qualifications. The target salary ranges are listed.

Due to the nature of our business and the role, please note that Intuitive and/or your customer(s) may require that you show current proof of vaccination against certain diseases including COVID-19. Details can vary by role. Intuitive is an Equal Opportunity Employer. We provide equal employment opportunities to all qualified applicants and employees, and prohibit discrimination and harassment of any type, without regard to race, sex, pregnancy, sexual orientation, gender identity, national origin, color, age, religion, protected veteran or disability status, genetic information or any other status protected under federal, state, or local applicable laws. Mandatory Notices U.S. Export Controls Disclaimer: In accordance with the U.S. Export Administration Regulations (15 CFR §743.13(b)), some roles at Intuitive Surgical may be subject to U.S. export controls for prospective employees who are nationals from countries currently on embargo or sanctions status. Certain information you provide as part of the application will be used for purposes of determining whether Intuitive Surgical will need to (i) obtain an export license from the U.S. Government on your behalf (note: the government’s licensing process can take 3 to 6+ months) or (ii) implement a Technology Control Plan (“TCP”) (note: typically adds 2 weeks to the hiring process). For any Intuitive role subject to export controls, final offers are contingent upon obtaining an approved export license and/or an executed TCP prior to the prospective employee’s start date, which may or may not be flexible, and within a timeframe that does not unreasonably impede the hiring need. If applicable, candidates will be notified and instructed on any requirements for these purposes. We will consider for employment qualified applicants with arrest and conviction records in accordance with fair chance laws. Preference will be given to qualified candidates who do not reside, or plan to reside, in Alabama, Arkansas, Delaware, Florida, Indiana, Iowa, Louisiana, Maryland, Mississippi, Missouri, Oklahoma, Pennsylvania, South Carolina, or Tennessee. This position may be filled at a different job level than listed here depending on

business need and/or on the selected candidate’s experience, knowledge and skills.

Compensation will be based primarily on the job level at which the role is filled and the

candidate’s qualifications, consistent with applicable law.

Accommodation & Accessibility Notice:

Intuitive is committed to providing reasonable accommodations to qualified individuals with disabilities. If you require assistance or an accommodation during any part of the application or interview process, please contact People Services at HRHelpNow@intusurg.com. We provide market-competitive compensation packages, inclusive of base pay, incentives, benefits, and equity. It would not be typical for someone to be hired at the top end of range for the role, as actual pay will be determined based on several factors, including experience, skills, and qualifications. The target compensation ranges are listed.

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