GAMP jobs in North Carolina

North Carolina

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Today

Title: Sr. Level CSV Engineer Location: NC Exp: At least 8-12yrs THIS IS A BACKFILL Client is seeking an experienced CSV Engineer to support key validation activities at a leading pharmaceutical manufacturing site. The contractor will play a critical role in ensuring compliance with regulatory and company standards by providing validation and technical support throughout the lifecycle of various systems and processes. Qualifications: Degree: Bachelor's degree in Engineering, Computer Science

Contract, Third Party

MES Engineer

Remote or Needham, Massachusetts

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12d ago

Title: MES Technical Consultant Regulatory Relevance: GxP The Role: The MES Technical Consultant will serve a key role owning the development and validation of core MES recipe objects and accompanying integrations. Additionally, this individual will also be well versed in Infobatch report development, web development, SQL, ISA S-95 standards will be act as an escalation point contact for the MES, Infobatch and ODH teams for complex initiatives. Key Responsibilities: Lead the design, development,

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Full-time, Third Party

$60 - $70

Business Analyst

Clayton, North Carolina

•

Today

Job#: 2085249 Job Description: Apex Systems is currently hiring for an IT Systems Manager with a reputable pharma client. IT Systems Manager is needed to support the an expansion project onsite in Clayton, NC. The ideal candidate will manage multiple systems simultaneously, provide project oversite & drive deliverables, and partner with key stakeholders. This resource will ensure adherence to the clients' & regulatory requirements for assigned IT Systems. The role will report to the IT/Automatio

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Full-time

USD 50.00 - 55.00 per hour

Controls Engineer (DeltaV)

Remote

•

Today

Title: Controls Engineer (DeltaV) Location : Remote - but must be in the Kalamazoo, MI area Target Start Date : ASAP Type: Direct Hire Salary : $120-160K (DOE) plus uncapped bonus Our client, a Top 5 systems integrator for automation & controls systems with over 40 years of experience, is seeking an experienced Controls Engineer to design, configure, and implement Emerson DeltaV automation solutions, primarily for life sciences and other process manufacturing industries. This role involves deliv

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Full-time

USD 120,000.00 - 160,000.00 per year

CSA Auditor, TraceLink

Remote

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11d ago

We are seeking a Computerized System Assurance (CSA) Auditor with deep experience in TraceLink and GxP-regulated environments to ensure the compliance, validation, and lifecycle integrity of computerized systems supporting serialization, traceability, and supply chain management. This role is critical in evaluating vendors, systems, and processes to meet FDA, EMA, and global regulatory expectations for data integrity and system validation. Key Responsibilities: Plan, conduct, and report CSA aud

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Contract

85 - 90

Sr. IT Program Manager

Remote or Massachusetts

•

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

Staff Engineer - Software Quality - Indianola, Pa (Hybrid)

Remote or Indianola, Pennsylvania

•

Today

At Bayer we're visionaries, driven to solve the world's toughest challenges and striving for a world where 'Health for all Hunger for none' is no longer a dream, but a real possibility. We're doing it with energy, curiosity and sheer dedication, always learning from unique perspectives of those around us, expanding our thinking, growing our capabilities and redefining 'impossible'. There are so many reasons to join us. If you're hungry to build a varied and meaningful career in a community of br

Full-time

USD 97,264.00 - 145,897.00 per year

CSV Engineer

Wilson, North Carolina

•

Today

Job Description: The CSV Engineer will support the generation, execution, and documentation of qualification activities for Emerson DeltaV (Client), Siemens PLC, and other GMP automation systems. This role ensures all validation and qualification deliverables comply with the client's global team and site-specific quality and compliance standards. Responsibilities: Develop and execute AIOQ protocols (approximately 60) for automation systems including DeltaV, PLC, Client, and L2SS. uthor and revie

Full-time

Senior CSV Engineer

Remote or Massachusetts

•

Today

Job Description: We are looking for a Senior Computer System Validation (CSV) Engineer to perform validation of computerized systems associated with Client's facilities, utilities, and equipment for the qc lab validation project. This role will focus on EMS, Client, and laboratory informatics/software platforms (e.g., HPLC/qPCR control software, Sicknotes, Blue Mountain), ensuring compliance with 21 CFR Part 11, Annex 11, and data integrity requirements. The CSV Engineer will obtain documentatio

Full-time

Validation Engineer II

Remote or Durham, North Carolina

•

Today

Job Description Summary The Validation Engineer II, assists with the authoring, executing and reviewing of SOP's, commissioning documentation, documents required for validation/qualification. Job Description Location: Durham, NC Please note this role is on-site 5 days a week and does not have the ability to work remotely. This role is based in Durham, NC. Novartis is unable to offer relocation support for this role: please only apply if this location is accessible for you. Responsibilities:

Full-time

USD 70,000.00 - 130,000.00 per year

CSV and Validation Engineer

Remote or New Jersey

•

Today

Job Description: We are seeking a hands-on CSV and Validation Engineer to validate software used with laboratory instruments and lab informatics platforms. The role owns risk-based validation planning and execution aligned to EMA Annex 11 and 21 CFR Part 11, authors audit-ready documentation, and partners with QA/IT/Lab to transition systems to standardized SOPs. Responsibilities: Plan and execute computer system validation using a risk-based CSA approach aligned to GAMP 5. Validate instrument

Full-time

Computer System Validation - CSV Engineer

Remote or New Jersey

•

Today

Roles & Responsibilities: Minimum 8+ years of relevant experience; can work independently and guide/mentor Junior resources. Experience in the Pharmaceutical, biotechnology, or medical device industry with System Development Lifecyle in Computer System Validation Experience in FDA and/or Global regulated environment with good understanding of GxP standards and Risk based validation. Knowledge of FDA guidance's and industry standards (i.e., GAMP) Experience in writing and executing documen

Full-time

Computer System Assurance

Remote

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26d ago

Location Remote (USA) Must Have Skills: Proven experience in CSA and GAMP 5 implementation.RTM configuration in any ALM tool, exposure to the Veeva CMS tools, need to have CSM admin experience.Strong knowledge of Veeva validation management and a basic understanding of Veeva configurations.Excellent analytical and problem-solving skills.Strong verbal and written communication abilities.Demonstrated ability to work effectively with global, virtual teams.Experience working independently, guiding

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Contract

$45+

Director - Lab Informatics

Remote

•

Yesterday

Position Summary: The Director of Lab Informatics is responsible for developing and executing a comprehensive informatics strategy to support laboratory operations across multiple functional areas including analytical development, quality control (QC), and manufacturing science and technology (MSAT). The role will drive innovation and digital transformation by integrating advanced informatics platforms that enhance data integrity, increase operational efficiency, and ensure regulatory complianc

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Contract, Third Party

Director, Lab Informatics

Remote

•

Yesterday

Director, Lab Informatics Job Location- Remote Long Term Position Summary: The Director of Lab Informatics is responsible for developing and executing a comprehensive informatics strategy to support laboratory operations across multiple functional areas including analytical development, quality control (QC), and manufacturing science and technology (MSAT). The role will drive innovation and digital transformation by integrating advanced informatics platforms that enhance data integrity, incre

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

Laboratory Information Management System (LIMS) Director

Remote

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2d ago

Role: Lab Informatics Location- Remote Duration: 12+ Month Position Summary: The Director of Lab Informatics is responsible for developing and executing a comprehensive informatics strategy to support laboratory operations across multiple functional areas including analytical development, quality control (QC), and manufacturing science and technology (MSAT). The role will drive innovation and digital transformation by integrating advanced informatics platforms that enhance data integrity, increa

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Third Party, Contract

Depends on Experience

Senior Accounting Associate

Remote

•

Today

Core Accounting Skills Knowledge of GAAP accounting principles Invoice processing and reconciliations Journal entries and vendor setup 1099 processing and reporting Experience with AP/GL systems Familiarity with financial applications (Coupa, Oracle, Guidewire) Handles ACH, and Zelle payment processing.

Contract

Depends on Experience

Federal Cost Accounting Standards SME

Remote

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11d ago

Technical Skills: Cost Accounting 7 to 10 years Budgeting and forecasting 7 to 10 years SAP S/4HANA Finance 7 to 10 years Role Description: MUST HAVE COST ACCOUNTING PROCESS EXPERIENCE (whether or not they have SAP). Responsible for configuring and implementing the Controlling (CO) module within SAP for U.S. government agencies or their contractors. The role ensures that cost accounting practices comply with federal regulations, such as the Federal Acquisition Regulation (FAR) and Cost Acc

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Contract

65 - 70

Local- Onsite!!! MES Specialist (Syncade) //Holly Springs, NC

Holly Springs, North Carolina

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2d ago

Hi , My name is Tanya. I just received details on a great job that I believe you would be a great fit for. Please take a look below and share your interest. TITLE- MES Specialist (Syncade) LOCATION- Holly Springs North Carolina NEED LOCAL DURATION- 6 MONTHS INTERVIEW- VIDEO . Required Skills: Previous experience as an automation engineer supporting an Emerson DeltaV MES (Syncade) project Previous experience working in a cGMP environment or working with FDA regulations Prior experience with deb

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Contract

$60 - $65

Federal SAP Cost Accounting Standards SME (US Cit to pass security clearance)

Remote

•

15d ago

We are seeking to hire a Federal SAP Cost Accounting Standards SME (CO module expertise) to join our team working on a new multi-year award we have within a large Federal Gov t Agency in Washington, DC. This role is 100% remote. Being a US Cit is REQUIRED for passing the Security Clearance to work on this program (ability to pass Public Trust at minimum). This position pays a strong salary package with full benefits (including choice of healthcare plans, dental, vision, life insurance, 3 weeks P

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Full-time

Depends on Experience

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GAMP jobs in North Carolina, USA