OQ jobs in Bernardsville, NJ

Raritan, New Jersey

•

Today

Summary: We are seeking a talented Validation Engineer to join our team. As a Validation Engineer, you will play a crucial role in ensuring the quality and compliance of our manufacturing processes and systems. You will be responsible for designing, implementing, and executing validation protocols to ensure that equipment, facilities, and processes meet regulatory requirements and industry standards. Roles & Responsibilities: Design and develop validation protocols for SCADA technology used in t

Full-time

Computer System Validation Engineer

Princeton, New Jersey

•

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

Validation Engineer

New Brunswick, New Jersey

•

Today

Job Description: Computerized Systems Validation (CSV) position involves ensuring that GxP-regulated computer systems and software comply with current Good Manufacturing Practices (cGMP) regulations, international guidelines (like 21 CFR Part 11 and Annex 11), and company standards by validating their functionality throughout their lifecycle. Key responsibilities include developing and reviewing validation documentation (protocols, reports), performing risk and impact assessments, coordinating

Full-time

Computer System Validation Engineer 1

Remote

•

Today

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

Easy Apply

Contract

SAP PPQM PTS Consultant Remote

Remote or Atlanta, Georgia

•

Yesterday

Job Id: #CGEMJP00321513 Title: SAP PPQM PTS Consultant Location: Remote Duration: 12+ Months Position Summary: Job Role and Responsibilities: We are looking for a highly skilled Senior SAP PPQM Consultant with over 6 years of experience in SAP Production Planning (PP) and Quality Management (QM) modules, specifically within the pharmaceutical industry. The ideal candidate will have a deep understanding of GxP compliance, regulatory requirements, and validation documentation. This role involv

Easy Apply

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

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

Senior Supplier Engineer

Remote or Danvers, Massachusetts

•

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 91,000.00 - 147,200.00 per year

Validation Engineer III

Remote or Durham, North Carolina

•

Today

Job Description Summary The Validation Engineer , is responsible for authoring, executing and reviewing/approval 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. Responsi

Full-time

USD 89,600.00 - 166,400.00 per year

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

Medical Affairs Business Implementation Lead

Bernardsville, New Jersey

•

Today

Job Description We are seeking a dynamic and experienced Medical Affairs Business Implementation Lead to drive the execution of strategic initiatives, with a focus on digital transformation projects and validated systems. This role serves as a critical liaison between Medical Affairs business units and IT, ensuring seamless integration of technology solutions, including GxP-compliant systems, to enhance operational efficiency and support healthcare professionals (HCPs). The ideal candidate will

Easy Apply

Full-time

Veeva Migration Consultant

Remote

•

27d ago

We have a below position for Veeva Migration expert for remote work, please find the JD below and let me know your interest. Title: Veeva Migration Consultant Exp: 7+ to 10 years of experience in Veeva migration and implementation activities Duration: 6-12 Months Responsibilities: Migration Work stream Lead-Veeva RIMS Implementation Key Responsibilities Migration Strategy & PlanningDefine migration scope, timelines, resources, and success metrics.Develop detailed migration plans and risk mitiga

Easy Apply

Contract, Third Party

Depends on Experience

LabVantage LIMS Configurator

Remote

•

Today

RAYVEN IT Solutions is a leading IT Consulting firm offers a comprehensive range of services that are domain specific with a strong focus on technology, business process & practices. Founded by top-notch profs with the vision of bridging the gap between people, process & technology. RAYVEN has the capability & resources to help clients realize their technology driven business transformation initiatives. We are specialized & provide solution-based services to our clients in the areas of SAP/ERP.

Easy Apply

Contract, Third Party

Depends on Experience

Business Implementation Lead - Medical Affairs

Bernards, New Jersey

•

Today

Amtex Systems Inc is an information technology and talent solutions company offering talent and BI consulting to the companies in US for over 25 years. Our solutions are designed to fill resource gaps, by providing the right candidates who deliver value to the organization. Our propensity to nurture and build strong relationships with our clients helps us better understand their business demands and gives us the ability to provide services that are on time and rise above the rest. Job Title:

Easy Apply

Third Party, Contract

Computer System Validation (CSV) Engineer

Remote or Massachusetts

•

Today

Responsibilities: Lead and execute CSV activities across GxP-regulated systems (LIMS, MES, ERP, etc. uthor 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 degree

Full-time

Sr Process Validation Engineer

Franklin Lakes, New Jersey

•

Today

Responsibilities: uthor and execute Master Validation Plans (MVPs), OQ (Operational Qualification), and PQ (Performance Qualification) protocols and reports in compliance with regulatory and internal standards. Lead validation activities for critical manufacturing processes including: Liquid phase mixing of formulation materials. Lyophilization (freeze-drying). Moulding and sizing of bioabsorbable components. Maintain and own Process FMEA (pFMEA) documentation and risk management files in accord

Full-time

LIMS and QC Applications Consultant

Remote or Hybrid in Bridgewater, New Jersey

•

Today

Solution Architecture and Design: Lead the design and development of LabVantage LIMS solutions tailored to business and laboratory needs. Develop system workflows, configurations, and integrations with other enterprise systems (e.g., S4 Hana ERP, MES, ELN, SDMS). Define data models, interface designs, and system configurations. Implementation and Deployment: Oversee installation, configuration, and validation of LabVantage LIMS applications. Develop and execute project plans, ensuring timely an

Easy Apply

Full-time, Contract

BASED ON EXPERIENCE

Filter Results

Job post features

Posted date

Work settings

Employment type

Distance

Employer type

Work authorization

OQ jobs in Bernardsville, NJ, USA