validation/system engineer Jobs in raleigh, nc

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Computer System Validation Engineer

Katalyst Healthcares and Lifesciences

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Remote or New Jersey, USA

Full-time

Roles & Responsibilities: Full lifecycle validation for all applicable computerized systems, ensuring they are designed, validated, operated and retired in compliance with GxP regulation and computer system validation (CSV) guidance. Compiling and maintaining accurate CSV documentation, ensuring full traceability throughout system lifecycles. Compliance Analysis, Validation Planning, Risk Assessments Test planning and strategy creation and execution of test protocols, scripts and reports. V
Posted 51 days ago | Updated 1 hour ago

Cleaning Validation Engineer

Zachary Piper Solutions, LLC

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Raleigh, North Carolina, USA

Full-time

Piper Companies is actively seeking a Cleaning Validation Engineer to join our team at a new manufacturing facility. The successful candidate will play a critical role in the development, implementation, and maintenance of cleaning validation processes, ensuring compliance with GMP standards and regulatory requirements. This is a Monday - Friday, traditional hours role located in the greater Raleigh, NC area. Responsibilities of the Cleaning Validation Engineer: Develop and execute cleaning val
Posted 19 days ago | Updated 17 days ago

CQV Validation Engineer

Katalyst Healthcares and Lifesciences

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Holly Springs, North Carolina, USA

Full-time

Job Description: We are seeking experienced CQV (Commissioning, Qualification, and Validation) Validation Engineers to join our team for immediate contract assignments. These roles are focused on the close-out phase of CQV activities for major capital projects within a fast-paced, regulated manufacturing environment. Responsibilities: Close Out CQV Protocols: Finalize and close out Commissioning, Qualification, and Validation protocols, including Installation Qualification (IQ), Operational Qua
Posted 13 hours ago | Updated 1 hour ago

Process Engineer I - API Cleaning Validation

Novo Nordisk Inc

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Clayton, North Carolina, USA

Full-time

About the Department At Novo Nordisk, we are helping to improve the quality of life for millions of people worldwide. For more than 100 years, we have led the way in diabetes care. Being part of Novo Nordisk allows our employees to embark on life-changing careers, and the opportunity to help improve the quality of life for millions of people around the world. In NC, we operate three pharmaceutical manufacturing facilities that are responsible for fulfilling different steps in our injectable an
Posted 3 days ago | Updated 1 hour ago

Cleaning Validation Engineer

Zachary Piper Solutions, LLC

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Holly Springs, North Carolina, USA

Full-time

Piper Companies is looking for a Cleaning Validation Engineer that will play a critical role in the development, implementation, and maintenance of cleaning validation processes for a brand new manufacturing facility. This position requires a thorough understanding of cleaning validation principles, regulatory requirements, and industry best practices. The successful candidate will ensure that all cleaning procedures are validated and compliant with GMP standards. Responsibilities of the Cleani
Posted 19 days ago | Updated 17 days ago

Cleaning Validation Engineer

Zachary Piper Solutions, LLC

•

Holly Springs, North Carolina, USA

Full-time

Piper Companies is seeking a Cleaning Validation Engineer to join a growing leader in the pharmaceutical/biotechnology space for an onsite position in Holly Springs, North Carolina (NC) . The Cleaning Validation Engineer will play a critical role in the development, implementation, and maintenance of cleaning validation processes for our new manufacturing facility. This position requires a thorough understanding of cleaning validation principles, regulatory requirements, and industry best prac
Posted 20 days ago | Updated 17 days ago

Cleaning Validation Engineer (Pharma)

Zachary Piper Solutions, LLC

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Holly Springs, North Carolina, USA

Full-time

Piper Companies is looking for a Cleaning Validation Engineer that will play a critical role in the development, implementation, and maintenance of cleaning validation processes for a brand new manufacturing facility. This position requires a thorough understanding of cleaning validation principles, regulatory requirements, and industry best practices. The successful candidate will ensure that all cleaning procedures are validated and compliant with GMP standards. This is an on-site position in
Posted 20 days ago | Updated 17 days ago

Cleaning Validation Engineer

Zachary Piper Solutions, LLC

•

Holly Springs, North Carolina, USA

Full-time

Piper Companies is seeking a Cleaning Validation Engineer located on-site in Holly Springs, NC. The Cleaning Validation Engineer will be responsible for developing and implementing cleaning validation protocols and conducting reports. Responsibilities of the Cleaning Validation Engineer include: Develop a cleaning validation program and execute protocols and reports for new facilities and equipment. Identify potential contamination sources through risk assessments and establish necessary clea
Posted 22 days ago | Updated 17 days ago

Computer System Validation Analyst - R Studio & Clinical Systems

Katalyst Healthcares and Lifesciences

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Remote or New Jersey, USA

Full-time

Responsibilities: Lead validation planning, risk assessment, and execution for R Studio, GitLab, and Medidata Rave EDC. Develop and execute validation documentation including: Validation Plans (VP.). User Requirements Specifications (URS.). Risk Assessments (RA.). Functional and Design Specifications. Traceability Matrix (RTM.). Test Protocols (IQ/OQ/PQ or CSA-based scripts.). Validation Summary Reports (VSR.). Collaborate with cross-functional stakeholders including Clinical Data Mana
Posted 51 days ago | Updated 1 hour ago

Engineer III, Validation

Thermo Fisher Scientific

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Remote or Fair Lawn, New Jersey, USA

Full-time

Work Schedule Standard (Mon-Fri) Environmental Conditions Office Job Description When you're part of Thermo Fisher Scientific, you'll do meaningful work, and join a team that values performance, quality and innovation. As part of a successful, growing global organization you will be encouraged to perform at your best. With revenues of more than $40 billion and the largest investment in R&D in the industry, we give our people the resources and chances to create significant contributions to the
Posted 38 days ago | Updated 1 hour ago

Engineer III, Validation

Thermo Fisher Scientific

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Remote or Waltham, Massachusetts, USA

Full-time

Work Schedule Standard (Mon-Fri) Environmental Conditions Office Job Description COMPANY: Thermo Fisher Scientific Inc. LOCATION: 168 Third Avenue, Waltham, MA 02451 TITLE: Engineer , Validation HOURS: Monday to Friday, 8:00 am to 5:00 pm DUTIES: Perform technical diagnosis of operational problems, repairs, and calibrations on a wide range of laboratory equipment to ensure that the equipment is operating to the customer's complete satisfaction and manufacture specifications; Perform techn
Posted 4 days ago | Updated 1 hour ago

Engineer II, Validation

Thermo Fisher Scientific

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Remote or St. Louis, Missouri, USA

Full-time

Work Schedule Standard (Mon-Fri) Environmental Conditions Adherence to all Good Manufacturing Practices (GMP) Safety Standards, Cleanroom: no hair products, jewelry, makeup, nail polish, perfume, exposed piercings, facial hair etc allowed, Cold Room/Freezers -22degreesF/-6degrees C, Laboratory Setting, Office, Some degree of PPE (Personal Protective Equipment) required (safety glasses, gowning, gloves, lab coat, ear plugs etc.) Job Description As part of the Thermo Fisher Scientific team, you
Posted 10 days ago | Updated 1 hour ago

Data Validation Quality Analyst (Only w2 - Need Healthcare exp)

Analytics Solutions

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Remote

Contract

Role Type: Data Validation Quality Analyst Duration : 6 months Telecommute : Yes Description: Data Validation Quality Analyst Position Overview: We are seeking a highly skilled Data Validation Quality Analyst to join our Cloud Data Modernization project team. This role involves migrating an on-premises Enterprise Data Warehouse (SQLServer) to a target cloud tech stack utilizing Azure Cloud data tools (ADF, SHIR, Logic Apps, ADLS Gen2, Blob Storage, etc.), Databricks and Snowflake. The primary
Easy Apply
Posted 2 days ago | Updated 2 days ago

Validation Lead, SAP S4 HANA

Katalyst Healthcares and Lifesciences

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Remote or New Jersey, USA

Full-time

Responsibilities: Lead the validation team in a strategic, risk-based approach that optimizes legacy Computer System documentation, CSA strategies and strong SAP ECC->S/4 HANAconversion knowledge to successfully deliver a validated system meeting all project requirements. Review, approval, and processing of Computer System Lifecycle deliverables including: User Requirements, Specifications, Test Plans, IQ, OQ, PQ Test Scripts, User Guides. Fostering of effective relationships with implementati
Posted 51 days ago | Updated 1 hour ago

Sr. Analyst, IT Validation Services

Russell, Tobin & Associates

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Remote or Stamford, Connecticut, USA

Contract

Job Title: Sr. Analyst, IT Validation Services Location: Remote Duration: 12 Months Pay Range: $30/hr-$35/hr on W2 (DOE) Primary Responsibilities Creation, review, approval, and DMS processing of Computer System Lifecycle deliverables for Projects and Change Controls: Validation Plans/Summary Reports Risk Assessments User Requirements Specifications Test Plans Test Scripts: IQ, OQ or PQ Assess and implement the most effective validation strategy for each activity. Oversee test execution for c
Easy Apply
Posted 30 days ago | Updated moments ago

Validation Specialist

Zachary Piper Solutions, LLC

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Clayton, North Carolina, USA

Full-time

The Validation Specialist join a leading global pharmaceutical company that is rapidly expanding its international presence, with plans to double in both size and production in the coming years. The Validation Specialist will be responsible for executing and reviewing revalidations, ensuring compliance with regulatory standards, and collaborating with cross-functional teams to support validation protocols and investigations. This role is essential in maintaining the accuracy of validation proces
Posted 19 days ago | Updated 17 days ago

Technical Lead - Validation, Tools, and Acceleration (VTA)

General Motors

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Remote

Full-time

Job Description Remote: This role is based remotely but if you live within a 50-mile radius of [Atlanta, Austin, Detroit, Warren, Milford or Mountain View ], you are expected to report to that location three times a week, at minimum. Role Overview: As a Technical Lead within the Validation, Tools, Acceleration (VTA) team under the Simulation, Evaluation, and Data organization, you will be a senior individual contributor building and optimizing the infrastructure and required technology for all