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Added 40 mins ago
Product Development Engineer II, Label Solutions
Avery Dennison
Miamisburg, OH
…materials, radio-frequency identification (RFID) inlays and tags, software applications that connect the physical and digital and offerings that enhance branded packaging and carry or…
Added 1 hour ago
Software Engineer Consultant - Salesforce (Remote - NC, AZ, TX)
First Citizens Bank
Raleigh, NC · Phoenix, AZ · Austin, TX
As a Software Developer Consultant, you will have the opportunity to influence solution design, improve engineering practices, modernize DevOps capabilities, and help shape the future…
Added 2 hours ago
Telecomm Engineer I / Telecomm Engineer II - Oahu, Maui, Hawai'i**EE REFERRAL ELIGIBLE**
Hawaiian Electric
Honolulu, HI
Telecomm Engineer I / Telecomm Engineer II - Oahu, Maui, Hawai'iEE REFERRAL ELIGIBLE
Added 3 hours ago
M
Software Engineer II
Microsoft
CA · Mountain View, CA · Mountain View
- $102,100 to $219,200 USD / year
We are looking for a Software Engineer II to join our team. Our Global Secure Access Datapath team builds cutting-edge network security solutions that enable enterprises to protect their…
Added 3 hours ago
M
Software Engineer II - CTJ - TS/SCI
Microsoft
VA · WA · Reston, VA · Redmond, WA · Reston · Redmond
- $102,100 to $219,200 USD / year
Microsoft has an exciting opportunity for a Software Engineer in the Cloud+AI Silver Team. This team will be responsible for deploying and operating a Secure Work Area, including the…
Added 3 hours ago
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Security Engineer II - Red Team
Microsoft
WA · Redmond, WA · Redmond
- $102,100 to $219,200 USD / year
We are looking for a Security Engineer II to execute operations and collaborate with other experienced red teamers to identify and exploit vulnerabilities across all layers of services,…
Added 4 hours ago
DevSecOps Security Engineer
Leidos
Gaithersburg, MD
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Application Engineer II (PAS-X) - SDF
Novo Nordisk
Durham, NC
…identified local manufacturing applications. Improve reliability of process control systems to meet current & projected customer, business & regulatory requirements through the following…
Added 5 hours ago
OneStream Lead Analytics and Insights Engineer II Manager
Deloitte
Houston, TX · Fort Worth, TX · Westlake, TX · Dallas, TX
2+ years leading implementations within an agile or hybrid-agile software development lifecycle and coordinating development, functional, and business process teams across multiple pods or…
Added 7 hours ago
Engineer II
Rosendin
Austin, TX
Review, comment, and process equipment and system submittals in coordination with the Engineer of Record.
Added 7 hours ago
Engineer II
Rosendin
Sterling, VA
Review, comment, and process equipment and system submittals in coordination with the Engineer of Record.
Added 7 hours ago
Engineer II
Rosendin
Coppell, TX
Review, comment, and process equipment and system submittals in coordination with the Engineer of Record.
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Engineer II
Rosendin
Coppell, TX
Review, comment, and process equipment and system submittals in coordination with the Engineer of Record.
Added 7 hours ago
Engineer II
Rosendin
Pflugerville, TX
Review, comment, and process equipment and system submittals in coordination with the Engineer of Record.
Added 8 hours ago
Software Design Engineer Intern
DataRobot, Inc.
Boston, MA · Seattle, WA · San Francisco, CA
Collaborative Software Engineering: Working in an async-first culture using Git, code reviews, Slack, and agile delivery practices.
Added 9 hours ago
Software Engineer II
RTX
United States
Collins Aerospace is seeking a qualified Senior Software Engineer to support the Identification Friend or Foe (IFF) programsAt RTX, the world's largest aerospace and defense company,…
Added 9 hours ago
Engineer II, Manufacturing
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…cargo vehicles through a custom-build, mixed-model assembly process. Each vehicle is produced in our purpose-built facility in Riverside, California supporting public agencies and private…
Added 9 hours ago
DevSecOps Security Engineer
Leidos
Egg Harbor Township, NJ
Leidos is seeking a DevSecOps Security Engineer to join the Air Traffic Business Area within the Homeland Sector, supporting the development of the Leidos Common Automation Platform…
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Information Security Solutions Engineer II
Auto Truck Group LLC
Trenton, NJ
- $105,050 to $149,700 USD / year
Holman is looking for a Security Engineer to work where cloud infrastructure and software development meet. You will review and design security architecture for our cloud environments,…
Added 9 hours ago
Engineer - II
Morongo Casino Resort & Spa
Cabazon, CA
The Engineer II performs intermediate-level maintenance, troubleshooting, and repair work throughout Morongo Casino Resort & Spa. This position supports the safe and efficient operation of…
Added 9 hours ago
Mgr, Distribution Control Center
Entergy
Beaumont, TX
…for network and regions. Reviews the call-out rosters and the process to notify networks about after-hours work. Is an SME for the Entergy Callout Software. Schedules additional personnel…
Added 9 hours ago
Sr. Security Engineer (Vulnerability Management)
SpaceX
Bastrop, TX · Cape Canaveral, FL
As a member of the SpaceX Vulnerability Management team, the Security Engineer will act as a trusted partner to application software development teams. This role focuses on identifying,…
Added 9 hours ago
Engineer II, Process
IPS-Integrated Project Services
Blue Bell, PA
…in the life sciences industry. We are looking for a talented Process Engineer II to join our dedicated team at our office located in Blue Bell,…
Added 10 hours ago
Engineer II (Private Credit Operations)
SMB Shared Services, Inc.
Newark, DE
Job Title: Engineer II (Private Credit Operations)
Added 10 hours ago
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Sr. Software Systems Validation Engineers
Rivian and Volkswagen Group Technologies
Palo Alto, CA
- $160,000 to $175,000 USD / year
…field and 2 years of experience in any occupation as systems engineer, embedded software developer, or related. Must have experience working with the following: Software or embedded systems…

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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