21 CFR Part 11 Jobs

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Sycamore SCE Administrator (Statistical Computing Environment)

Virtualan Software

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Boston, Massachusetts, USA

Third Party, Contract

Job Title: Sycamore SCE Administrator (Statistical Computing Environment) Location: Hybrid at Boston, MA Job Type: C2C / Full time Overview: We are seeking an experienced Sycamore SCE Administrator to manage and maintain our Statistical Computing Environment (SCE) used for clinical and statistical analysis. The ideal candidate will have deep hands-on experience with the Sycamore platform and a strong background in statistical computing within regulated environments such as pharmaceuticals or lif
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Posted 3 days ago

Validation Lead

Radiansys, Inc.

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Foster City, California, USA

Full-time

Validation Lead Foster City, CA 94404 (Onsite) FTE / CTH / Contract Job/ Role Description: Proven leadership in testing, validation for medium to large system implementations, ensuring GxP compliance and quality deliveryExtensive experience with Waterfall, Iterative, and Agile methodologies, guiding teams to successful project outcomesProficient in Microsoft Office Suite (Project, Visio, Excel, PowerPoint) for project management and reportingExpertise in HP ALM for managing testing cycles, with
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Posted 1 day ago | Updated 18 hours ago

Validation Lead

EA Team, Inc.

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Foster City, California, USA

Third Party, Contract

We are in Critical need of Validation Lead for Long Term Contract in Foster City, CA Role : Validation LeadLocation : Foster City, CADuration : Fulltime HireJob Description : Proven leadership in testing/validation for medium to large system implementations, ensuring GxP compliance and quality delivery.Extensive experience with Waterfall, Iterative, and Agile methodologies, guiding teams to successful project outcomes.Proficient in Microsoft Office Suite (Project, Visio, Excel, PowerPoint) for p
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Posted 7 days ago | Updated 2 days ago

MES Engineer

TSR Consulting Services, Inc.

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Summit, New Jersey, USA

Contract

Our client, a leading pharmaceutical company, is hiring a MES Engineer, on a contract basis. Job ID #: 82365 Work Location: New Brunswick, NJ - 50% on site Summary: Seeking a Senior MES Engineer/Validation Lead to take ownership of computer system validation activities for Manufacturing Execution Systems (MES) supporting cell therapy manufacturing. This role is ideal for someone with a strong IT/Computer Science foundation and 3 years of hands-on experience in the pharma/biotech industry. Youll
Posted 9 hours ago

MES Engineer

Sunrise Systems, Inc.

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Summit, New Jersey, USA

Contract

Job Title: MES Engineer Job ID: 25-07988 Location: Summit, NJ Duration: 06 Month s Contract on W2 Candidates must be onsite 50% of the time at either Summit West, Giralda Farms, Princeton Pike, Lawrenceville, or New Brunswick. Must Have List4+ years of Computer System Validation (CSV) experience in regulated pharmaceutical and biotech environments, with strong knowledge of GAMP 5, 21 CFR Part 11, and Computer Software Assurance (CSA) principles.3+ years of hands on MES experience with Emerson S
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Posted 15 hours ago

MES Engineer

Primary Talent Partners

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Summit, New Jersey, USA

Contract

Primary Talent Partners has a 6 month contract opening for a MES Engineer to join a major pharma client for a position.Pay: $55.00-60.00/hr based on experience and academia W2 Contract: 6 months, extensions likely, conversion possible Type: W-2, cannot support C2C or provide visa sponsorship Location: Onsite - Summit, NJOverview: We re seeking a Senior MES Engineer/Validation Lead to take ownership of computer system validation activities for Manufacturing Execution Systems (MES) supporting cel
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Posted 15 hours ago | Updated 7 hours ago

Computer System Validation (CSV) Engineer

Jobot

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Scottsdale, Arizona, USA

Full-time

Computer System Validation (CSV) Engineer with strong knowledge of FDA and cGMP regulations and documentation practices and 21 CFR Part 11. needed! (**Full relocation provided**) This Jobot Job is hosted by: Ryan Sullivan Are you a fit? Easy Apply now by clicking the "Apply Now" button and sending us your resume. Salary: $130,000 - $145,000 per year A bit about us: We are a fast-growing, Medical Device Manufacturer in Scottsdale, AZ, passionate about improving the lives of patients suffering
Posted 1 day ago | Updated 8 hours ago

Senior Veeva QMS Support Analyst

I.T. Solutions

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San Francisco, California, USA

Contract

Sr. Veeva QMS Support Analyst San Francisco, CA Type: Contract Length: 3 months, maybe extensions Job Summary: We are seeking a detail-oriented and technically skilled Veeva QMS Support Specialist to provide end-user support, configuration assistance, and continuous improvement for our Veeva Quality Management System (QMS). This role serves as a bridge between Quality, IT, and end users, ensuring smooth implementation and operation of Veeva QMS modules including Change COntrol, Deviations (QE)
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Posted 7 days ago

Computer System Validation Specialist

SGS Consulting

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Remote

Contract

Job Title: Computer System Validation (CSV) Specialist Duration: 08 Months + (Possible Extension) Location: Wilmington, DE 19803 (Remote) Schedule: M-F: 08 AM 05 PM Kindly Do not apply if you are not or Permanent Resident of USA. Qualifications: The official position title is Computer System Validation (CSV) specialist to support the Newark manufacturing facility with validation of new and existing computerized systems.This role will primarily support the Newark manufacturing facility but may r
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Posted 8 days ago

MES Engineer (Syncade)

Zachary Piper Solutions, LLC

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Holly Springs, North Carolina, USA

Full-time

Piper Companies is hiring a MES Engineer (Syncade) for a biomanufacturing hub locate din Holly Springs, NC. The MES Engineer (Syncade) will be supporting the integration and configuration of Emerson DeltaV MES for two manufacturing facilities, ensuring compliance with cGMP standards and paperless workflows. The MES Engineer (Syncade) is a long term contract opportunity and will require the candidate to work on site in Holly Springs, NC 4 days per week. Responsibilities of the MES Engineer (Sync
Posted 27 days ago | Updated 10 hours ago

LIMS and QC Applications Consultant

Expedite Technology Solutions

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Remote or Bridgewater, New Jersey, USA

Full-time, Contract

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
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Posted 23 days ago | Updated 7 hours ago

LabVantage LIMS Architect

Macrosoft

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Bridgewater, New Jersey, USA

Full-time

We are seeking a highly skilled LabVantage LIMS (Laboratory Information Management System) Architect to design, implement, and optimize LabVantage solutions that meet the complex needs of our organization. This role is critical for ensuring our laboratory operations run seamlessly, with robust systems that enable efficiency, compliance, and scalability. As the LabVantage LIMS Architect, you will collaborate with stakeholders, including laboratory personnel, IT teams, and vendors, to design custo
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Posted 19 days ago | Updated 7 days ago

Automation and Controls Engineer

1 Point System

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Decatur, Illinois, USA

Full-time

Position Title: Automation and Controls Engineer Department: Engineering Reports To: Head of Engineering Work Location: Decatur, Illinois Essential Duties & Responsibilities: Routinely maintains, troubleshoots, and develops application solutions for automated electromechanical systems and software. Experience in a senior level position with planning, scheduling, and organizing project activities. Performs corrective maintenance on facility and production equipment including, but is not limite
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Posted 3 days ago

Veeva CRM Architect

Astrobyte Solutions LLC

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Remote

Full-time

ob Title: Veeva CRM Technical ArchitectLocation: Remote Duration: Long term contract/ Full time Educational Qualification*Bachelor's or Master's degree in Computer Science, Information Technology, Engineering, or a related technical field. Additional certifications in Salesforce, Veeva CRM/Align are highly preferred.Job Description of Role* (RNR) (Mandatory - Minimum 500 words)Job Summary: We are seeking an experienced Veeva CRM Consultant with a strong background in Salesforce and Life Sciences
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Posted 17 days ago | Updated 10 days ago

Electrical/Automation SME

Zachary Piper Solutions, LLC

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Bloomington, Indiana, USA

Full-time

Piper Companies is seeking a BioPharma Electrical/Automation Subject Matter Expert (SME) to manage the construction and communication of a new facility build for a CDMO out in Bloomington, IN. The role has an onsite expectation and slated through 2026 and potentially beyond. The SME will provide technical leadership and subject matter expertise throughout the design, construction, commissioning, and qualification of a new pharmaceutical manufacturing facility. This role will be responsible for e
Posted 3 days ago | Updated 10 hours ago

Validation Engineer

Synkriom

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Summit, New Jersey, USA

Contract

Essential Functions: Maintains all qualified and validated equipment and systems in compliance with policies, guidelines and procedures. Develops protocols, and associated reports while adhering to a change management process. Supports the execution of equipment qualifications and validation protocols Supervises vendors for qualification functions. Supports equipment qualification and systems validation activities. Configures and documents the configuration of computerized systems Develops valid
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Posted 1 day ago

Sr. Reliability Engineer

Medtronic

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Remote or North Haven, Connecticut, USA

Full-time

We anticipate the application window for this opening will close on - 7 May 2025 Position Description: Sr. Reliability Engineer for Covidien, LP (a Medtronic company) located in North Haven, CT. Responsible for development of reliability testing methodologies for electrical and mechanical components and subsystems, test methods, and validation activities to meet requirements. Interface with cross-functional group members, various suppliers, and test laboratories. Perform data analysis using sta
Posted 57 days ago | Updated moments ago

Senior Engineer, Automation

Abbvie

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Worcester, Massachusetts, USA

Full-time

Company Description AbbVie's mission is to discover and deliver innovative medicines and solutions that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on people's lives across several key therapeutic areas - immunology, oncology, neuroscience, and eye care - and products and services in our Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at Follow @abbvie on X, Facebook, Instagram, YouTub
Posted 8 days ago | Updated 12 hours ago

Computer System Validation (CSV) Engineer (Onsite)

DP Professionals Inc

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Columbia, Maryland, USA

Contract

DPP is seeking a Computer System Validation (CSV) Engineer for our client in Columbia, Maryland. This is a direct hire opportunity. Work arrangement: Onsite W2 position; full time employee Position description: The Computer System Validation Engineer (CSV Engineer) ensures that all computer systems and software used in manufacturing and laboratory environments comply with regulatory requirements and industry standards. This role involves developing, executing and maintaining validation protocols
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Posted 3 days ago | Updated 7 hours ago

Controls Engineer (Mid-Level)

Mastech Digital

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Wilmington, Massachusetts, USA

Full-time

Mastech Digital provides digital and mainstream technology staff as well as Digital Transformation Services for all American Corporations. We are currently seeking a Controls Engineer (Mid-Level) for our client in the Engineering Solutions domain. We value our professionals, providing comprehensive benefits and the opportunity for growth. This is a Permanent position, and the client is looking for someone to start immediately. Duration: Full-time Location: Wilmington, MA (Onsite) Salary: $120,00
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Posted 16 days ago | Updated moments ago