GxP jobs

SAP Solution Architect [ OTC & Logistics & MM ]

Remote

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20d ago

Job Title: SAP Solution Architect OTC & Logistics & MM (Life Sciences) Location: Remote Experience Level: 15+ years in SAP Consulting Role Overview We are seeking an experienced SAP Solution Architect with deep expertise in Order-to-Cash (OTC) and Logistics Execution (LE) processes and secondary skills in Material Management (MM). The ideal candidate will have a strong understanding of end-to-end business processes, preferably within the Life Sciences industry, and a proven track record of deliv

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Contract

Depends on Experience

Sr Director / AVP - Digital Engineering

Franklin Township, New Jersey

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Today

Location: East Rocky Hill, NJ Salary: $185,000.00 USD Annually - $200,000.00 USD Annually Description: Our client is currently seeking a Sr Director / AVP - Digital Engineering About the Role We're looking for a strategic and experienced technology leader to drive our digital engineering initiatives within the pharmaceutical and life sciences domain. As Senior Director / AVP, you'll define and execute the digital technology roadmap, lead high-performing engineering teams, and deliver scal

Contract

USD 185,000.00 - 200,000.00 per year

Computer System Validation Engineer 1

Remote

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6d ago

Title: CSV Engineer 1 Location: Remote About: The CSV Engineer 1 will support Computer System Validation (CSV) activities for GxP-regulated systems. This role involves executing validation deliverables, ensuring compliance with FDA 21 CFR Part 11, EU Annex 11, and company quality standards. The candidate will work closely with IT, Quality, and Business teams to maintain a validated state of systems. Key Responsibilities Assist in the development and execution of validation documentation, inclu

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Contract

AWS Infrastructure Qualification & Validation Specialist

Redwood City, California

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Today

Summary: We are seeking a skilled professional to lead and execute Infrastructure Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ) documentation for AWS-hosted environments. This role is critical in ensuring our cloud infrastructure meets regulatory compliance standards (e.g., GxP, HIPAA, ISO 27001) through robust validation and documentation practices. Roles & Responsibilities: Develop and maintain IQ/OQ/PQ documentation for AWS infrastructure components. C

Full-time

Computer System Validation Engineer

Princeton, New Jersey

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Today

Job Description Summary: The CSV Specialist is responsible for planning, coordinating, and executing validation activities for computer systems to ensure compliance with regulatory requirements. This role involves working closely with IT, Quality Assurance, and business stakeholders to validate new and existing systems, document validation evidence, and support audits and inspections. Roles & responsibility: Knowledge on FDA Guidance's and industry Standards Develop and execute validation plan

Full-time

AWS Infrastructure Qualification & Validation Specialist

California

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Today

Job Description (JD): For a role focused on Infrastructure Qualification and Validation Documentation for AWS-tailored for regulated environments like pharma, biotech, or any GxP-compliant organization. We are seeking a skilled professional to lead and execute Infrastructure Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ) documentation for AWS-hosted environments. This role is critical in ensuring our cloud infrastructure meets regulatory compliance standar

Full-time

Clinical SAS Programmer

Santa Clara, California

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Today

Responsibilities: The Sr. Statistical Programmer supports the Biostatistics team in the generation and validation of analysis datasets and statistical outputs for clinical trials This role is key to implementing programming standards and supporting the standardization of CDISC-compliant datasets (e.g., SDTM, ADaM) across clinical programs Develop and validate SAS programs to generate analysis datasets, tables, listings, and figures (TLFs) that support clinical trial reporting, regulatory submiss

Full-time

Controls Manager/Sr Automation Controls Engineer

Austin, Texas

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Today

Job Posting Start Date 12-11-2025 Job Posting End Date Flex is the diversified manufacturing partner of choice that helps market-leading brands design, build and deliver innovative products that improve the world. A career at Flex offers the opportunity to make a difference and invest in your growth in a respectful, inclusive, and collaborative environment. If you are excited about a role but don't meet every bullet point, we encourage you to apply and join us to create the extraordinary. Job

Full-time

Computer System Validation Engineer

Bothell, Washington

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3d ago

Job Title: Computer System Validation Engineer Location: Bothell, WA (50% Onsite) Duration: 6 Months Work Type: Hybrid (3 days a week onsite) and required to be onsite throughout UAT execution PURPOSE AND SCOPE OF POSITION: The Computer Systems Validation (CSV) Contractor works cross-functionally to lead and execute validation activities for GxP electronic systems and applications.This role is an individual contributor. The CSV Contractor will partner with Business Owners, Technical Owners, a

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Contract

$73 - $75

Principal Engineer TSMS Validation

Concord, North Carolina

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Today

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

Full-time

USD 66,000.00 per year

Senior CSV Engineer

Cambridge, Massachusetts

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Today

Roles & Responsibilities: - Build and maintain ETL pipelines, metadata, mappings, and automated data quality/validation rules. Configure elluminate study modules (Mapper, Data Central, CTOA, Sample Management, Protocol Deviations) and translate requirements into specifications. Contribute in testing/validation (IQ/OQ/PQ, UAT) efforts, manage audit trails, and resolve issues with vendors and study teams. Develop dashboards/analytics across elluminate modules and monitor system performance, inte

Full-time

Sr. IT Program Manager

Remote or Massachusetts

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Today

Work Schedule Standard (Mon-Fri) Environmental Conditions Office Job Description Uncover a remarkable opportunity at Thermo Fisher Scientific Inc. to push global advancements in health, cleanliness, and safety as a Sr. IT Program Manager in Waltham. Become a part of our elite team, guiding ambitious IT projects that enhance quality, compliance, and supply chain operations within our Contract Development and Manufacturing Organization (CDMO). Argument Development & Case Creation Collaborate

Full-time

USD 143,000.00 - 214,475.00 per year

Statistical Software Configuration Specialist (Statistica TIBCO)

Remote or Hybrid in Vacaville, California

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Today

Statistical Software Configuration Specialist (Statistica TIBCO) Vacaville, CA / A hybrid model (once or twice in the office) / Remote Duration: - 6-12 Months+ For a "Statistica Software configuration specialist" role, which likely involves both data analytics and potentially on-site manufacturing support or collaboration, a hybrid model (once or twice in the office) is a probable arrangement. Statistical Software Configuration Specialist (Statistica TIBCO) Position Overview The Statistical Soft

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Contract, Third Party

Depends on Experience

Verification Support Engineer

Louisville, Kentucky

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Today

Roles & Responsibilities: Pharmacy Verification Support engineer for a minimum of 4 years. Working knowledge of software or system validation in regulated industry like Medical Device or Pharma. Strong knowledge and experience of computerized system development life cycle (SDLC) approaches and validations strategies is required. Experience with COTS/Custom made Analytical Instrument and experience working in QC Laboratories, R&D, manufacturing/operations is required. Software Quality Engineer (S

Full-time

Scrum Master

Princeton, New Jersey

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3d ago

Job title: Scrum Master Job ID: 25-11422 Location: Princeton Pike, NJ (Lawrenceville) - 50% onsite Hours: Monday- Friday 8 am-5 pm Position Summary: The Scrum Master for Digital Projects with Commercial BI&T will be responsible for facilitating and guiding the Agile development process for our initiatives.This role involves working closely with cross-functional teams, including data scientists, machine learning engineers, software developers, and product owners, to ensure the successful deliver

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Contract

Up to $77

Manager, Data Product Owner

Remote or Hopewell Township, New Jersey

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Today

At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity. Learn m

Full-time

USD 117,000.00 - 201,250.00 per year

Sr. Principal Infrastructure Architect - Manufacturing & Quality Systems

Indianapolis, Indiana

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Today

Full-time

USD 126,000.00 - 224,400.00 per year

2026 Summer Internship Program: Data Digital and Technology (DD&T) Intern

Round Lake, Illinois

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Today

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 The Data Digital & Technology (DD&T) team is responsible for all the Digital Improvements, Operational Efficiencies, and Innovative S

Full-time

USD 21.00 - 46.00 per hour

AD, Engineering (Design & Construction)

Durham, North Carolina

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Today

Job Description Summary #LI-Onsite Location: Durham, NC Novartis is seeking an Associate Director of Engineering (Design & Construction) to oversee the execution of large-scale capital investment projects critical to the advancement of our technical operations and pharmaceutical manufacturing. This position will be responsible for managing projects throughout their entire lifecycle-from conceptualization to commissioning-ensuring that all deliverables meet established timelines, budgets, and q

Full-time

USD 132,300.00 - 245,700.00 per year

CDMO-CTO Management Strategy and Operations Director

Lexington, Massachusetts

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Today

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 CDMO-CTO Management Strategy and Operations Director OBJECTIVES/PURPOSE: The Strategy and Operations Director owns the alignment of

Full-time

USD 174,500.00 - 274,230.00 per year

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