GAMP Jobs

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MES Consulting Engineer

Zachary Piper Solutions, LLC

•

Cary, North Carolina, USA

Full-time

Do you have a passion for optimizing manufacturing processes in the pharmaceutical industry? Are you an expert in PAS-X systems? If so, we want to hear from you! We are seeking a highly motivated MES Engineer to join our team and play a key role in the design and implementation of a PAS-X system for our state-of-the-art drug product and finished goods facility. Responsibilities: Collaborate with internal stakeholders to define MES requirements and develop User Requirement Specifications (URS)
Posted 13 days ago | Updated 4 hours ago

CSV/Validation Lead

Amaze Systems Inc

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King of Prussia, Pennsylvania, USA

Full-time, Contract, Third Party

Job title CVS Lead Location KOP, PA(Hybrid) Contract 12+ months JD- Keywords CSV, Computer System Validation, Product Serialization, DSCSA Roles and Responsibilities 10 years' Experience in Validating SAP/N systems in Manufacturing Experienced in CSV activities in Manufacturing related applications like SAP/Non Systems, Product Serialization systems, MES systems Perform review for GxP systems to ensure compliance with regulatory requirements Working knowledge on end-to-end validation of GxP ap
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Posted 2 days ago | Updated 7 hours ago

CSV Project Manager

Cognizant Technology Solutions

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Muskegon, Michigan, USA

Full-time

CSV Project Manager Cognizant Technology Solutions in LSMG is seeking for CSV Project Manager who could join our team of Engineering professionals in a permanent role. Our strength is built on our ability to work together. Our diverse set of backgrounds offer different perspectives and new ways of thinking. It encourages lively discussions, inspires thought leadership, and helps us build better solutions for our people and clients. We are looking for someone who thrives in this setting and is in
Posted 1 hour ago

Engineer - Degreed IV

Experis

•

Buffalo Grove, Illinois, USA

Full-time

Our client is seeking a Machine Vision Engineer to join their team. Job Title: Machine Vision Engineer Location: Buffalo Grove, IL Job Type: 1 year Contract Job Id: ABOJP00035012 Job Description: Purpose of Role Provide Machine Vision expertise and support to manufacturing processes. Support the implementation of Machine Vision related projects (mainly Cognex Insight Spreadsheet environment). Code Review/debug of a wide spectrum of bespoke vision jobs/algorithms. Investigate issues and dev
Posted 11 hours ago

Manager of Instrumentation and Calibration

AstraZeneca

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Rockville, Maryland, USA

Full-time

Join us as a Manager of Instrumentation and Calibration, where you will oversee departmental activities regarding the planning and scheduling of all routine and non-routine events and any related areas of responsibility to maintain a GMP facility. This is your chance to break new ground and leave a collective legacy in our Operations team! What you will do:Business Process Owner for Instrumentation and Calibration activities.Drive continuous improvement across processes and procedures.Develop a
Posted 1 day ago | Updated 3 hours ago

Manager- Maintenance Planning

AstraZeneca

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Rockville, Maryland, USA

Full-time

As Manager of Maintenance Planning and Master Data, you'll play a pivotal role in channeling our scientific capabilities to make a positive impact on changing patients' lives. It offers one of the most exciting, fast-paced, challenging, and rewarding work environments in the world of operations, supply chain, and manufacturing. What you will do: As a Business Process Owner for Maintenance Planning and Master Data activities - proactively apply Lean to drive continuous improvement across proces
Posted 1 day ago | Updated 3 hours ago

Automation Engineer - Experience in DeltaV

Cognizant Technology Solutions

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Muskegon, Michigan, USA

Full-time

Cognizant Technology Solutions in LSMG is seeking for an Automation Engineer who could join our team of Engineering professionals in a permanent role. Our strength is built on our ability to work together. Our diverse set of backgrounds offer different perspectives and new ways of thinking. It encourages lively discussions, inspires thought leadership, and helps us build better solutions for our people and clients. We are looking for someone who thrives in this setting and is inspired to craft m
Posted 44 days ago | Updated 1 hour ago

Senior Engineer, Automation- CAR-T

Johnson & Johnson

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Raritan, New Jersey, USA

Full-time

Description Janssen Pharmaceuticals, Inc., a member of Johnson & Johnson's Family of Companies, is recruiting for a Senior Engineer, Automation - CAR-T! At the Janssen Pharmaceutical Companies of Johnson & Johnson, we are working to create a world without disease. Transforming lives by finding new and better ways to prevent, intercept, treat and cure disease inspires us. We bring together the best minds and pursue the most promising science. We are Janssen. We collaborate with the world for the
Posted 6 days ago | Updated 5 hours ago

Security Centric DevSecOps Lead - Evinova

AstraZeneca

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Gaithersburg, Maryland, USA

Full-time

At Evinova, while we innovate to transform patient care through technology, we prioritize the security of our digital solutions to meet and exceed the exacting requirements of the healthcare industry. Transform billions of patients' lives through technology, data and pioneering ways of working. We're building a new type of health-tech business - Evinova, a fully-owned subsidiary of AstraZeneca Group. Evinova delivers market-leading digital health solutions that are science-based, evidence-led an
Posted 30 days ago | Updated 3 hours ago

SQE Validation Lead (LabX)

CGI

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Plymouth Meeting, Pennsylvania, USA

Full-time

SQE Validation Lead (LabX) Position Description CGI is seeking a seasoned validation software quality lead join our growing team supporting life science clients through end-to-end solution offerings and professional services. This must be able to work in a cross-functional environment and interact with representatives from CGI, and our end-clients. This validation engineer will work at various CGI/ clients consulting and executing various life science business and IT initiatives from validation
Posted 51 days ago | Updated 7 hours ago

Senior Director of Platform Data & Integrations - Evinova

AstraZeneca

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Gaithersburg, Maryland, USA

Full-time

Are you ready to be part of the future of healthcare? Are you able to think big, be bold, and harness the power of digital and AI to tackle longstanding life sciences challenges? Then Evinova, a new health-tech business part of the AstraZeneca Group might be for you! At Evinova, while we innovate to transform patient care through technology, we prioritize the security of our digital solutions to meet and exceed the stringent requirements of the healthcare industry. Transform billions of patient
Posted 9 days ago | Updated 3 hours ago

Senior Solution Engineer - Research and PDCS IT

AstraZeneca

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New Haven, Connecticut, USA

Full-time

This is what you will do: This position will partner on business strategy and driving process and technology across Data Sciences/Bioinformatics/Genomics, Internal Research, External Research, Bioanalytical Development, Translational Medicine, Pre-Clinical Research, and Discovery Sciences. The role will require the ability to match IT strategy to Research priorities and then translate this strategy into execution with a "hands-on" approach to delivering IT solutions. You will work with IT and bu
Posted 10 days ago | Updated 3 hours ago

Business Systems Analyst

Aegistech Inc.

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Boca Raton, Florida, USA

Full-time

A Business Systems Analyst job is available with our client, a company in the healthcare industry located in Boca Raton, FL. This is a 100% on-site position and a direct hire full-time role. TheBusiness Systems Analystis responsible for performing a variety of business system support activities at the Boca Raton facility. ESSENTIALS OF THE JOB: Function as a technical resource to facilitate the various stages of the data solutions life cycle including: Investigation, Analysis, Design, Testing, I
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Posted 60+ days ago | Updated 2 days ago

Automation Engineer (Delta V)

Vbeyond Corporation

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Indiana, USA

Full-time

Automation Engineer: Job Location: Remote + Travel / Indianapolis, IN (expecting ideal candidate to be onsite 2-3 days every 2 weeks) Fulltime Job Description: Roles & Responsibilities: Review and analysis of User Requirements Specification Documents Support development of the Detail Design specifications Development of Point Database Development of Control and Equipment Modules Development of Graphic User Interface Support software development, testing, commissioning and qualification Ability
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Posted 59 days ago | Updated 6 hours ago

Computer System Validation Specialist || No OPT and CPT

Shiro Technologies

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Remote

Contract

Role and Responsibilities: Possess hands-on experience with the Veeva Vault Quality Docs System. Develop Computer System Validation (CSV) deliverables including Validation Plan, Validation Protocols (IQ, OQ, PQ), Validation Summary Report, Data Migration Plan and Trace Matrice. Conduct GxP Risk Assessments on computer applications utilized in regulated environments. Perform system assessments in compliance with 21 CFR Part 11 and Annex 11 regulations. Collaborate with Business Users, System Owne
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Posted 7 hours ago

Senior CSV | Remote (EST) | Contract

SecureKloud Technologies Inc

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Remote

Contract, Third Party

Hi , Greetings from Securekloud, We do have opening for our client, Role : Computer System Validation Specialist Location : Remote (EST Timings) Duration : Long-Term Contract Job Description : Role and Responsibilities: Possess hands-on experience with the Veeva Vault Quality Docs System.Develop Computer System Validation (CSV) deliverables including Validation Plan, Validation Protocols (IQ, OQ, PQ), Validation Summary Report, Data Migration Plan and Trace Matrice.Conduct GxP Risk Assessment
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Posted 2 days ago

Senior Project Manager

Doublestar Inc.

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Woodbury, Minnesota, USA

Full-time

As a vital member of our Information Technology (IT) team, you will be responsible for overseeing various software related projects; many part of strategic company initiatives. The ideal candidate will possess a strong focus on team leadership, project methodology and best practice, with proven track record of successful projects in the enterprise software space. The work environment can be in St. Louis, MO or Woodbury, MN with preference for the St. Louis location. The role reports to the IT Di
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Posted 10 days ago

Manufacturing Systems Validation Specialist

Pyramid Consulting, Inc.

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Summit, New Jersey, USA

Contract

Immediate need for a talented Manufacturing Systems Validation Specialist . This is a 06+ Months Contract opportunity with long-term potential and is located in Summit, NJ (Onsite). Please review the job description below and contact me ASAP if you are interested. Job ID:24-17823 Pay Range: $47 - $57/hour. Employee benefits include, but are not limited to, health insurance (medical, dental, vision), 401(k) plan, and paid sick leave (depending on work location). Key Requirements and Technology
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Posted 13 days ago

Validation Engineer, Labware LIMS

I.T. Solutions

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Foster City, California, USA

Contract, Third Party

Validation Engineer, Labware LIMS Foster City, VA Length: year to start, likely extensions Responsibilities Develop Validation Plans and Change Controls for Labware LIMS (Laboratory Information Management System)Develop Validation testing strategy in accordance with Gilead's policy and proceduresWorking closely with System Manager, Quality Assurance and Business Process Owners to effectively and efficiently implement LIMS projectsAssist with understanding the business requirements, analyze and h
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Posted 7 days ago

Validation - Specialist, MSEO Manufacturing Systems Validation

Sunrise Systems, Inc.

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Summit, New Jersey, USA

Contract

Job Description: Minimum 50% onsite required every week (Candidate is supposed to align the onsite days with manager and be available onsite when manager requests) The Specialist works cross-functionally to execute validation activities and prepare validation deliverables for S12 Enterprise Manufacturing Execution System (EMES) used in cell therapy manufacturing. This role is primarily an individual contributor but will routinely support project and production works. The Specialist will partner
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Posted 13 days ago | Updated 10 days ago