CAPL Jobs in Boston, MA

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Validation Support Engineer

Katalyst Healthcares and Lifesciences

Boston, Massachusetts, USA

Full-time

Job Description: We are seeking an experienced Validation Support Engineer to lead validation activities for Beckhoff Twin CAT PLC-controlled systems in a 24/7 GMP-regulated manufacturing environment. The role focuses on ensuring compliance with FDA regulations (21 CFR Part 11, 210, 211, 820), GAMP5 methodologies, and internal quality standards. Responsibilities: Develop/update Validation Plans (VP) and Master Validation Plans (MVP). Lead GxP risk assessments for system changes. Author and

Quality Assurance Engineer (Medical Device)

Judge Group, Inc.

Framingham, Massachusetts, USA

Full-time

Location: Framingham, MA Salary: $90,000.00 USD Annually - $105,000.00 USD Annually Description: Our client is currently seeking a Quality Assurance Engineer (Medical Device). This is a permanent, direct hire, on site role. Key Responsibilities: Investigate material nonconformance issues and resolve supplier concerns. Maintain calibration system and ensure compliance with 21 CFR 820 & ISO 13485. Support manufacturing engineering with documentation and process improvements. Assist in prod

Validation Engineer III

Katalyst Healthcares and Lifesciences

Waltham, Massachusetts, USA

Full-time

Responsibilities: Local Validation Program Maintenance. QAV Documentation Review and Approvals for local and CMO's. CS Periodic Reviews planning and approvals. QA GMP IT Support for DI and CS INF activities. Validation and Metrology QMS events ownership as QAV (Change Control, CAPA & Deviation). QRFR's Generation. Metrology Deliverables Review & Approval (forms or SOP's) + SAP Operation. SME support on the GMP Equipment Calibration/ PM/ Breakdown assessment from QAV Technical perspective. V

Specialist Quality Control

Aditi Consulting

Remote or Thousand Oaks, California, USA

Contract

Payrate: $36.60 - $38.90/hr. Summary: Under general supervision, this position will perform routine procedures (i.e., NC/CAPA/CC) and process improvements projects to support Corporate Quality Control. Specific responsibilities include performing investigations to support corrective actions, procedures revision, Training portfolio, monitoring and revising SAP Mater data Quality Inspection plans, and projects implementation plan. Will also be responsible for documenting, computing, compiling, int

Data Integrity Lead

Katalyst Healthcares and Lifesciences

Boston, Massachusetts, USA

Full-time

Responsibilities: Facilitate holistic data integrity reviews by partnering with QA and stakeholders to conduct end-to-end business processes assessments. Prioritize gaps and risks and provide oversight to needed remediation activities. Serving as a Strategic Quality Lead (providing project management, leadership, and participation) for DTE computerized system life cycle (SLC) activities for Vertex GxP systems. Managing and Facilitating Data Mapping initiatives for programs level processes. Provi

Sr CAPA Engineer

Fresenius Medical Care

Remote or Waltham, Massachusetts, USA

Full-time

If your location allows for pay/benefit transparency, please click the link below to request further information on this position. Pay Transparency Request Form ADDENDUM: GMS CAPA Office Focus Responsible for development of an appropriate strategy to implement all necessary requirements from FME Quality Management and formerly used NC/CAPA tools into one global electronic NC/CAPA tool. Assists global NC/CAPA process owner with process definition, documentation, implementation, and maintenance.

Sr. Design Quality Engineer

Judge Group, Inc.

Newton, Massachusetts, USA

Full-time

Location: Newton, MA Salary: $70.00 USD Hourly - $100.00 USD Hourly Description: Job Title: Principal Quality Engineer Location: MA Duration:- 12 + Months Responsibilities: Represent the Quality Department as a subject matter expert in Incoming Inspection/Supplier Quality within a cross-functional team for new product development of medical devices. Develop and implement methods and procedures for inspecting, testing, and evaluating the precision and accuracy of components/material/products

Clinical Laboratory Scientist

Software Guidance & Assistance

Boston, Massachusetts, USA

Contract

Software Guidance & Assistance, Inc., (SGA), is searching for a Clinical Laboratory Scientist for a contract assignment with one of our premier BioTech services clients in Boston, MA. Responsibilities : The Quality Assurance department is a key and critical role at the firm and works with various teams within the firm. As part of the Laboratory Operations Quality team, this position supports day-to-day quality management laboratory activities, evaluates and designs laboratory processes in colla

Senior Sterilization Engineer

Amgen Inc

Cambridge, Massachusetts, USA

Full-time

Career Category Engineering Job Description Join Amgen's Mission of Serving Patients At Amgen, if you feel like you're part of something bigger, it's because you are. Our shared mission-to serve patients living with serious illnesses-drives all that we do. Since 1980, we've helped pioneer the world of biotech in our fight against the world's toughest diseases. With our focus on four therapeutic areas -Oncology, Inflammation, General Medicine, and Rare Disease- we reach millions of patients eac

Software Developer 4

Oracle Corporation

Burlington, Massachusetts, USA

Full-time

Job Description Entity: Oracle America, Inc. Job Duties: Design, develop, troubleshoot and/or test/QA software. As a member of the software engineering division, apply knowledge of software architecture to perform tasks associated with developing, debugging, or designing software applications or operating systems according to provided design specifications. Build enhancements within an existing software architecture and/or suggest improvements to the architecture. May telecommute. (385.34787)

Automation Engineer III

Sanofi U.S.

Framingham, Massachusetts, USA

Full-time

Job Title: Automation Engineer Location: Framingham, MA About the Job We deliver 4.3 billion healthcare solutions to people every year, thanks to the flawless planning and meticulous eye for detail of our Manufacturing & Supply teams. With your talent and ambition, we can do even more to protect people from infectious diseases and bring hope to patients and their families. The MA Bio-Campus is home to Sanofi's digital facility which won ISPE's Facility of the Future and Facility of the Year

Principal Diagnostic Engineer

Oracle Corporation

Burlington, Massachusetts, USA

Full-time

Job Description As part of the Communication Global Business Unit Development Team, the applicant will be working as an integral part of a hardware team working in a diagnostic / hardware verification environment with emphasis on board and system-level testing. The successful candidate will be responsible for planning, designing, writing, debugging and optimizing functional tests for Oracle's Session Border Controller (SBC) and Cloud Connector hardware used in engineering, manufacturing and fie

PTC Arena Consultant

Teknikoz

Remote

Third Party, Contract

Key Responsibilities:Lead the technical delivery of PLM solutions using PTC Windchill and Arena PLM/QMS. Guide a team of engineers and consultants across India and the USA. Configure, customize, and maintain PLM modules such as BOM, Change Management, Document Control, and Lifecycle Management. Collaborate with business stakeholders to gather requirements and design scalable PLM workflows. Oversee PLM/ERP integrations and ensure data integrity across systems. Provide mentorship, code reviews, an

CyberSecurity Solutions Engineer - US Commercial

Cisco Systems, Inc.

Boston, Massachusetts, USA

Full-time

The application window is expected to close on June 6, 2025 Job posting may be removed earlier if the position is filled or if a sufficient number of applications are received. Ideal candidate will be located in Boston, Massachusetts or the New England Region Please Note: This role is Home Office based; However, travel is required in the New England Region Meet the Team You will be a part of an outstanding technical pre-sales team in our Global Security Sales Organization (GSSO), responsible f

Software Architect - Technical Leader

Cisco Systems, Inc.

Boston, Massachusetts, USA

Full-time

The application window is expected to close on June 13, 2025. However, the job posting may be removed earlier if the position is filled or if a sufficient of applications are received. Meet the Team The Cisco Security Business Group (SBG) focuses on empowering the world to reach its full potential, securely through our products. The SBG Security team supports this mission by building thoughtful partnerships with our internal partners to drive security strategy alignment across the SBG portfoli

Senior Manager Software Engineering

Boston Scientific Corporation

Marlborough, Massachusetts, USA

Full-time

Innovation - Diversity - Caring - Global Collaboration - Winning Spirit - High Performance At Boston Scientific, we'll give you the opportunity to harness all that's within you by working in teams of diverse and high-performing employees, tackling some of the most important health industry challenges. With access to the latest tools, information and training, we'll help you in advancing your skills and career. Here, you'll be supported in progressing - whatever your ambitions. Senior Software M

Data Strategy Program Manager - C15 - NY

Citi

Remote or New York, New York, USA

Full-time

Citi, the leading global bank, has approximately 200 million customer accounts and does business in more than 160 countries and jurisdictions. Our core activities are safeguarding assets, lending money, making payments and accessing the capital markets on behalf of our clients. Citi's Mission and Value Proposition explain what we do and Strategy explain how we do it. Our mission is to serve as a trusted partner to our clients by responsibly providing financial services that enable growth and ec

ASIC Verification Engineer

Cisco Systems, Inc.

Maynard, Massachusetts, USA

Full-time

The application window is expected to close on 6/30/2025 This is an onsite role with a strong preference working out of the Maynard, MA office location, but can also be based out of our San Jose, CA or RTP, NC offices. Meet the Team: Acacia, part of Cisco, provides innovative silicon-based high-speed optical interconnect products to accelerate network scalability through advancements in performance, capacity, and cost. Our DSP ASICs, silicon photonic PICs, and coherent modules empower cloud a

Software Engineer - Technical Lead - Acacia

Cisco Systems, Inc.

Maynard, Massachusetts, USA

Full-time

The application window is expected to close on 5/09/25. Job posting may be removed earlier if the position is filled or if a sufficient number of applications are received. Acacia designs intelligent transceivers using advanced signal processing and photonic integration for the 100G, 400G and 1T bit speed fiber optic transmission market deployed in data center, metro, long-haul and ultra-long haul telecommunication networks. Meet the Team Acacia's software team is responsible for embedded CPU

Agile Release Train Engineer

Lockheed Martin Corporation

Remote or Herndon, Virginia, USA

Full-time

Job Description Space is a critical domain, connecting our technologies, our security and our humanity. While others view space as a destination, we see it as a realm of possibilities, where we can do more - we can innovate, invest, inspire and integrate our capabilities to transform the future. At Lockheed Martin Space, we aim to harness the full potential of space to cultivate innovation, reduce c The GEOINT Visualization Services (GVS) system, managed by the Strata program, was first deploy