GAMP Jobs

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Computer System Validation Lead

Nityo Infotech Corporation

•

Remote

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 2 hours ago

Sr DeltaV Automation Engineer Onsite

Tektree Systems Inc.

•

Muskegon, Michigan, USA

Contract, Third Party

Muskegon, MI - onsite daily We need someone who has developed automation code within DeltaV (Control Modules through to Equipment Modules, Phases and Recipes) and familiar with troubleshooting code errors, not just associates with a background in using DeltaV from on operator perspective. This role entails making changes to software, identifying errors and then testing hence Validation profiles will be DISQUALIFIED. Job Summary: This is an onsite role to help with commissioning efforts of a D
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Posted 60+ days ago | Updated 7 days ago

SUD Validation Engineer

Thermo Fisher Scientific

•

Logan, Utah, USA

Full-time

Work Schedule Standard (Mon-Fri) Environmental Conditions Office Job Description As part of the Thermo Fisher Scientific team, you'll discover meaningful work that makes a positive impact on a global scale. Join our colleagues in bringing our Mission to life every single day to enable our customers to make the world healthier, cleaner and safer. We provide our global teams with the resources needed to achieve individual career goals while helping to take science a step beyond by developing so
Posted 24 days ago | Updated 7 hours ago

Manufacturing Technician (2nd shift)

Cube Hub, Inc.

•

Redwood City, California, USA

Contract

Job Title : Manufacturing Technician Location : Redwood City, CA, 94063 Duration : 12 months Contract-possible to extend Shift Details : 2nd shift-1:30 Pm to 10PM Pay Range : $23/hr. - $25/hr. Job Description: Typical Accountabilities o Conduct activities and interactions consistent with Company values and in compliance with the Code of Conduct and supporting Policies and Standards relevant to your role. Complete all required training on the Code of Conduct and supporting Policies and Stand
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Posted 6 days ago | Updated moments ago

Senior Staff, Software Quality Assurance Engineer

Stryker

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Portage, Michigan, USA

Full-time

Work Flexibility: Hybrid Senior Staff, Software Quality Assurance Engineer Stryker is seeking a Senior Staff Software Quality Assurance Engineer to support our Digital Robotics and Enabling Technologies business by driving quality processes. In this role, you will partner with R&D software development teams to guide them through internal quality system processes and ensure compliance with regulatory standards, including FDA, HIPAA, ISO, and SOC 2. Work Flexibility: Hybrid: Candidates must resi
Posted 6 days ago | Updated 7 hours ago

Computer System Validation

Smart Source Technologies

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Jacksonville, Florida, USA

Contract

Computer System Validation Jacksonville, FL Onsite 12 months contract Pay : $55/hr W2 or $60/hr C2C Job Description:- Working knowledge of FDA and European medical device regulations (QSR and ISO) is required. Working knowledge of software validation requirements for software used in the production of medical devices and software used to support the Quality System is required. Working knowledge of GAMP5 and SDLC is required. Working knowledge of regulations for electronic records, electronic
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Posted 4 days ago | Updated 3 days ago

Sr DeltaV Automation Engineer

TeamSuccess LLC DBA HiEd Success

•

Muskegon, Michigan, USA

Contract

Sr DeltaV Automation Engineer Muskegon, MI - onsite Please note: We need someone who has developed automation code within DeltaV (Control Modules through to Equipment Modules, Phases and Recipes) and familiar with troubleshooting code errors, not just associates with a background in using DeltaV from on operator perspective. Job Summary: This is an onsite role to help with commissioning efforts of a DeltaV system and mentor other Junior and Intermediate Engineers. The client and the project tea
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Posted 38 days ago | Updated 31 days ago

SAP Integration Lead

Judge Group, Inc.

•

Boston, Massachusetts, USA

Contract

Location: Boston, MA Salary: $75.00 USD Hourly - $80.00 USD Hourly Description: Job Title: SAP Integration Lead Location: Boston, MA (Hybrid) Duration: 6+ months Contract Need Locals Only Required Qualifications: Bachelor's degree in Computer Science, Engineering, Life Sciences, or a related field8+ years of SAP integration experience, with 3+ years in a regulated pharmaceutical environmentExpertise in SAP CPI, PI/PO, IDoc/ALE, RFC, BAPI, and API-based integrationStrong understanding of SAP
Posted 24 days ago | Updated 4 hours ago

Control Engineer with Strong Exp. Programming Rockwell/Allen-Bradley PLCs

Combined Computer Resources

•

Pensacola, Florida, USA

Contract

Job Summary: We are seeking a skilled Control Engineer with hands-on experience in programming Rockwell PLCs and designing robust safety circuits. The ideal candidate will work closely with Mechanical Engineers and Technicians to modify, enhance, and commission control systems in a regulated environment. Key Responsibilities: Design, program, and debug Rockwell/Allen-Bradley PLC systems.Evaluate and implement machine safety circuits (ISO 13849, IEC 62061 compliance).Collaborate with Mechanical E
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Posted 23 days ago

Validation Lead

TechDigital Corporation

•

King of Prussia, Pennsylvania, USA

Third Party, Contract

Computer System Validation, Computed system assurance, GAMP, GxP risk assessments, Change Management 10+ years' Experience in Validating systems and Experienced in CSV activities in GxP related applications like SAP Systems, Product Serialization systems, MES systems Perform review for GxP systems to ensure compliance with regulatory requirements Working knowledge on end-to-end validation of GxP applications and is able to perform document/process Compliance Analysis Adept with Agile and Waterf
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Posted 23 days ago

Sr DeltaV Automation Engineer

Intone Networks Inc.

•

Michigan, USA

Full-time, Third Party, Contract

Sr DeltaV Automation Engineer - Muskegon, MI - onsite Job Summary: This is an onsite role to help with commissioning efforts of a DeltaV system and mentor other Junior and Intermediate Engineers. The client and the project team have been working very well together with high collaboration, communication, adaptability, and a good sense of camaraderie making the work environment enjoyable and engaging. We're looking someone who is strong technically but also a great team player, collaborative, an
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Posted 29 days ago | Updated 2 hours ago

C&Q Engineer - (Commissioning & Qualification) || Harrisburg, PA (Onsite)

Stellent IT LLC

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Harrisburg, Pennsylvania, USA

Contract, Third Party

Position: C&Q Engineer Location: Harrisburg, PA (Onsite) Duration: 12+ month contract Multiple Openings - Standard C&Q profile ideally with 7+ years' experience. More experience the better Job Description :- We are looking for a highly skilled Senior Commissioning & Qualification (C&Q) Engineer to support our Life Sciences projects. The ideal candidate will have extensive experience in qualification and validation activities, ensuring compliance with industry regulations and best practices.
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Posted 60+ days ago | Updated 1 hour ago

Desktop Support Specialist

TEKsystems c/o Allegis Group

•

Rockville, Maryland, USA

Full-time

Description Responsibilities and Job Duties -Provides direct technical support and assistance to end-users over the phone, in person and or remotely -Manages and handles all escalated tickets from Level1, identifies best solutions based on information provided by customers -Provides in depth technical support; diagnose and resolve problems ranging from Tier1 -3 type issues. Troubleshoots applications, errors, and operating systems (Windows 10). Mitigates and handles system viruses, malware, spyw
Posted 10 days ago | Updated 4 hours ago

Senior Validation Engineer

Takeda pharmaceutical

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Lexington, Massachusetts, USA

Full-time

By clicking the "Apply" button, I understand that my employment application process with Takeda will commence and that the information I provide in my application will be processed in line with Takeda's Privacy Notice and Terms of Use. I further attest that all information I submit in my employment application is true to the best of my knowledge. Job Description Pursuant to Section 20 C.F.R. 656.10, you are hereby notified that an application for Alien Employment Certification will be filed by
Posted 11 days ago | Updated 7 hours ago

Engineer - Syncade or PharmaSuite MES System

Eli Lilly and Company

•

Indianapolis, Indiana, USA

Full-time

At Lilly, we unite caring with discovery to make life better for people around the world. We are a global healthcare leader headquartered in Indianapolis, Indiana. Our employees around the world work to discover and bring life-changing medicines to those who need them, improve the understanding and management of disease, and give back to our communities through philanthropy and volunteerism. We give our best effort to our work, and we put people first. We're looking for people who are determined
Posted 6 days ago | Updated 7 hours ago

CSV Engineer

Katalyst Healthcares and Lifesciences

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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 10 days ago | Updated 7 hours ago

Engineer - MES System

Eli Lilly and Company

•

Indianapolis, Indiana, USA

Full-time

At Lilly, we unite caring with discovery to make life better for people around the world. We are a global healthcare leader headquartered in Indianapolis, Indiana. Our employees around the world work to discover and bring life-changing medicines to those who need them, improve the understanding and management of disease, and give back to our communities through philanthropy and volunteerism. We give our best effort to our work, and we put people first. We're looking for people who are determined
Posted 36 days ago | Updated 7 hours ago

Reliability Engineer

Cushman & Wakefield

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Boston, Massachusetts, USA

Full-time

Job Title Reliability Engineer Job Description Summary As a key member of the Reliability Engineering team, the lead Reliability Engineering will provide strategic and hands-on support for GxP Facility Operations and Engineering across Vertex GxP sites. This role will drive the implementation of maintenance and reliability best practices, focusing on maximizing equipment and system performance while ensuring compliance with GxP and Good Engineering Practices (GEP). The ideal candidate will lead
Posted 12 days ago | Updated 7 hours ago

Medical Device Engineer

Katalyst Healthcares and Lifesciences

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North Chicago, Illinois, USA

Full-time

Responsibilities: Develop, implement, and maintain software quality assurance processes for non-product software used in medical device development. Ensure adherence to regulatory standards (FDA, ISO 13485, IEC 62304) and industry best practices for non-product software. Support audits and inspections by regulatory bodies, ensuring that non-product software systems comply with quality and documentation standards. Ensure computerized systems are appropriately validated Assessment of applicabi
Posted 8 days ago | Updated 7 hours 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 15 days ago | Updated 7 hours ago