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Senior Validation Engineer

Katalyst Healthcares and Lifesciences

•

Lexington, Massachusetts, USA

Full-time

Responsibilities: Shire Human Genetic Therapies Inc. is seeking a Senior Validation Engineer with the following duties: Write Validation documents per Food Drug Administration (FDA)/Company guidelines; draft Specification documents and Validation Plans (VPs) for pharmaceutical manufacturing and laboratory equipment; Write and execute qualification protocols for new equipment and decommissioning protocols for old equipment. Execute approved protocols per company Good Documentation Practices (cG
Posted 4 days ago | Updated 10 hours ago

Clinical SAS Programmer

Katalyst Healthcares and Lifesciences

•

Princeton, New Jersey, USA

Full-time

Responsibilities: Effectively designs and codes SAS programs using BASE/SAS, SAS/STAT, SAS/GRAPH and SAS MACROS for assigned clinical projects(s). Produces and delivers CDISC and regulatory compliant SDTM, and ADaM standard datasets. Creates and validates tables, figures and listings (TFLs) in a timely and high-quality fashion, consistently meeting objectives of the study, and regulatory requirements. Provides input in the design and development of case report forms and clinical databases.
Posted 10 days ago | Updated 10 hours ago

Principal Regulatory Consultant Dietary Supplements

Apptad Inc

•

New Jersey, USA

Third Party, Contract

Job Description: Job Title: Principal Regulatory Consultant Dietary Supplements (U.S.-Based) Position Type: Contract / Consulting Location: Jersey City, NJ Department: Regulatory Affairs / Corporate Development Position Summary: We are seeking a highly experienced and credentialed Regulatory Consultant to support strategic M&A due diligence initiatives within the dietary supplement industry. This role demands deep understanding of the U.S. regulatory landscape, including DSHEA, FDA cGMPs (21 CFR
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Posted 8 days ago

EMBEDDED SOFTWARE TEST ENGINEER

Tekaccel, Inc

•

Cambridge, Massachusetts, USA

Full-time

Title: EMBEDDED SOFTWARE TEST ENGINEER Location: CAMBRIDGE, MA (100% ONSITE) Experience: 6+ Years Job Type: 6+ MONTHS CONTRACT TO FTE Job Description: MUST HAVE: EMBEDDED TESTING, RF DEVICES, AND PERFORMING RELATED TESTING, SPECTRUM ANALYZERS AND OSCILLOSCOPE, S FDA REGULATIONS (IEC 62304, 21 CFR PART 820), MEDICAL DEVICE BACKGROUND Required skills: Embedded testing experience Knowledge of IEC 62304, IEC 60601, and QMS 13485 Familiarity with networking terminology such as servers, switches, and
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Posted 27 days ago

Document Management Specilist (W2 Only - 100% Remote)

Performix Business Services, LLC

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Remote or Rochester, Minnesota, USA

Contract

Learn Division of Engineering tools and expectations.Document controls system (SolidWorks PDM) structure, navigation, and use.Engineering change order process.Document templates.Assist with document revisions from annual review. For each document:Accept redlines from document owner (facilitate review?).Review documents and suggest further incremental improvements.Verify reference documents section.Documents referenced in text are included in reference section.Documents in reference section exist
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Posted 1 day ago | Updated 15 hours ago

Validation Engineer

Katalyst Healthcares and Lifesciences

•

Irvine, California, USA

Full-time

Job Description: The Senior Validation Engineer will serve as a subject matter expert in validation, leading critical projects in support of GMP-compliant manufacturing and product development. This role involves strategic planning, execution, and continuous improvement of validation processes across multiple sites, while supporting audits, risk assessments, and global quality initiatives. Responsibilities: Interpret and implement validation requirements based on FDA regulations, corporate stan
Posted 2 days ago | Updated 10 hours ago

Principal Engineer

Katalyst Healthcares and Lifesciences

•

Plymouth, Minnesota, USA

Full-time

Job Description: This section focuses on the main purpose of the job in one to four sentences. Technical lead for DHF structure within sustaining engineering for disposable medical devices. Responsibilities: This section contains a list of primary responsibilities of this role that account for 5% or more of the work. The incumbent will perform other duties assigned. Manage a new 3rd-party supplier documentation strategy for peritoneal dialysis disposable sets. Manage change controls from init
Posted 5 days ago | Updated 10 hours ago

Database Architect

Stellar IT Solutions

•

St. Louis, Missouri, USA

Full-time, Part-time, Contract, Third Party

Job Title: Database Architect Location: St. Louis, MO (Onsite) Job Type: Long-term Contract Industry: Pharmaceutical / Healthcare (FDA-regulated environment) Summary: We are seeking a seasoned Database Architect with expertise in Oracle and SQL Server to oversee and optimize our enterprise database environments hosted at a third-party data center. This position will manage the hosting partner to ensure SLA adherence, assist with architectural decisions, and support application teams in build
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Posted 11 days ago | Updated 3 hours ago

CSV Engineer

Katalyst Healthcares and Lifesciences

•

Raritan, New Jersey, USA

Full-time

Roles & Responsibilities: 7-10 years' experience in Computer System Validation of SAAS systems, and Cloud systems. Must have experience in Agile methodology and handled multiple releases in parallel. Has working experience in any one or two of the following domains Tool validation like Service NOW, Automation tools, JIRA. Guide the project team with the right set of applicable project deliverables based on project type and category while catering to the SDLC. Application of FDA guidance's a
Posted 7 days ago | Updated 10 hours ago

CSV Lead - Raritan, NJ

Shrive Technologies LLC

•

New Jersey, USA

Contract, Third Party

Job Details: 7-10 years' experience in Computer System Validation of EMS and BMS applications Must have experience in Agile methodology and handled multiple releases in parallel Extensive knowledge in CSV, CSV auditing, creation and revision of CSV documentation, experience with EMS/BMS, project management, test script review, test execution review, test defect management. Has working experience in any one or two of the following domains Tool validation like ServiceNOW, Automation tools, JIRA Gu
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Posted 11 hours ago | Updated 11 hours ago

CSV Automation Engineer(Onsite) Location: North Kansas City, KS (Onsite)

Stellent IT LLC

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Kansas City, Kansas, USA

Third Party, Contract

Title - CSV Automation Engineer (Onsite) Location: North Kansas City, KS (Onsite) Duration: 3-6 Months (most likely 6) Industry: Pharmaceutical Job Description: We are currently seeking a highly experienced Computer System Validation (CSV) Automation Engineer to join an active pharmaceutical project in North Kansas City, KS. The engineer will play a key role in ensuring validated automation systems meet both regulatory and technical standards in a dynamic and fast-paced environment. The ideal
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Posted 7 days ago | Updated 9 hours ago

Plastics Process Engineer

Jobot

•

Tampa, Florida, USA

Full-time

Drive Process Excellence in Class I- Medical Device Manufacturing This Jobot Job is hosted by: Ryan Weingardt Are you a fit? Easy Apply now by clicking the "Apply Now" button and sending us your resume. Salary: $85,000 - $95,000 per year A bit about us: We are a Florida-based injection molder specializing in high-precision, low-to-mid volume production for the medical device and life sciences industries. With ISO Class 7 and 8 cleanroom capabilities and a track record of producing Class I, II
Posted 3 days ago | Updated 7 hours ago

Quality Inspector

Stellar IT Solutions

•

Madison, Wisconsin, USA

Full-time, Part-time, Contract, Third Party

Job Title: Quality Inspector Medical Device Manufacturing Location: Madison, WI Job Type: Contract or Full-Time (as applicable) Job Description: We are seeking a Quality Inspector to support daily device manufacturing operations in a medical device environment. This role ensures all processes, materials, and documentation comply with current Good Manufacturing Practices (cGMP), internal quality systems, and regulatory standards, including FDA QSR and ISO 13485. Key Responsibilities: Perform in
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Posted 26 days ago | Updated 3 hours ago

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
Posted 53 days ago | Updated 10 hours ago

Development Quality Engineer (W2 Only)

Generis TEK Inc.

•

Pleasanton, California, USA

Contract

We have Contract role Development Quality Engineer (W2 Only) for our client at Pleasanton CA. Please let me know if you or any of your friends would be interested in this position. Position Details: Development Quality Engineer (W2 Only) - Pleasanton CA Location : Pleasanton CA 94588 Project Duration : This is a 12 months contract with potential to extend highly likely Pay Rate : $35.00/hr. on W2 Hours : 8:00am 5.00 PM Job Description We are seeking a motivated and detail-oriented professional t
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Posted 13 hours ago

Mid Level Full Stack Developer -W2-FULL TIME ONLY (NO H1B/OPT/CPT EAD)

Paladin Consulting, Inc.

•

Dallas, Texas, USA

Full-time

Job Title: Mid-Level Java Full Stack Engineer Work Location: Remote Education/Experience Required: Bachelors degree in Computer Science or related field; Three (3) years of experience working in a SaaS-based product development environment or FDA-regulated medical device environment; experience working with AWS is a plus Job Description & Responsibilities : Designs, develops, and maintains web applications across both front-end and back-end systems.Works with technologies such as Java, Angular,
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Posted 1 day ago | Updated 1 day ago

Computer System Validation (CSV) Engineer

Katalyst Healthcares and Lifesciences

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Remote or Massachusetts, USA

Full-time

Responsibilities: Lead and execute CSV activities across GxP-regulated systems (LIMS, MES, ERP, etc. Author and maintain validation deliverables: URS, FS, DS, IQ, OQ, PQ, and traceability matrices. Ensure systems comply with 21 CFR Part 11, EU Annex 11, and GAMP 5. Support system implementations, upgrades, and periodic reviews. Collaborate with QA, IT, and business users to drive validation strategy. Participate in audits and inspections to demonstrate compliance. Requirements: Bachelor's
Posted 12 days ago | Updated 10 hours ago

Mechanical Engineer

Jobot

•

Vista, California, USA

Full-time

Excellent Opportunity to Join a Fast Growing Manufacturing Company! Competitive Salary and Stellar Benefits! This Jobot Job is hosted by: Jaclyn D'Amore Are you a fit? Easy Apply now by clicking the "Apply Now" button and sending us your resume. Salary: $85,000 - $100,000 per year A bit about us: We are seeking an experienced Manufacturing Engineer with a strong background in project management and regulated manufacturing environments. This individual will drive continuous improvement, optimi
Posted 19 hours ago | Updated 7 hours ago

SharePoint Technical Lead / Architect

Beacon Systems, Inc

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Lansing, Michigan, USA

Contract, Third Party

About Beacon Systems, Inc Beacon Systems, Inc, delivers Program Management, Science, Engineering, and Technology Solutions to Federal, Commercial, State, and Local Agencies. We are a subsidiary of Radiant Digital Solutions. Our Technology support to many DoD Agencies, NASA, Voice of America, FDA, and State Agencies such as State of FL, RI, MS, ND, VA, and WV extends our delivery of solutions worldwide. Position: SharePoint Technical Lead / Architect Duration: Long Term Location: Onsite - Lansing
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Posted 5 days ago | Updated 10 hours ago

Senior Regulatory Affairs Specialist

ZennSoft

•

Union City, California, USA

Full-time

Job Title: Senior Regulatory Affairs (RA) Specialist Location: Union City, CA Industry: Medical Devices / Regulatory Affairs Employment Type: Full-Time Client: Lhasa OMS, Inc. About the Role Lhasa OMS, Inc. is seeking a highly motivated Senior Regulatory Affairs Specialist to join our team in Union City, CA. The ideal candidate will support the Regulatory Affairs department by preparing and submitting regulatory documentation for medical devices in both domestic and international markets. This p
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Posted 7 days ago