GAMP jobs

Hybrid in Spring House, Pennsylvania

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14d ago

Job Title: Sr. PAS-X MES Engineer Location: Remote for 6 months, then on-site at Springhouse, PA Pay Rate: $65/hr-$95/hr (depending on experience) Length of Assignment: 6-12 Months Job Description: Project Summary: Client is implementing a highly automated Manufacturing Execution System (MES) leveraging Krber PAS-X 3.4. This program will integrate MES with multiple external systems, including DeltaV, eLIMS, AVEVA PI, and SAP. The MES Engineer will play a critical role in configuring PAS-X, defin

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Contract

$65 - $95

Technical Support Specialist II

Tewksbury, Massachusetts

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Today

Work Schedule Standard (Mon-Fri) Environmental Conditions Office Job Description Job Title: Technical Support Specialist II Location: United States Position Summary: Join our ambitious team at Thermo Fisher Scientific Inc. as a Technical Support Specialist II! In this customer service role, you will provide outstanding support to our customers, ensuring a flawless experience through timely troubleshooting and resolution of complex technical issues. You will collaborate with Field Service

Full-time

USD 32.00 - 43.00 per hour

Staff Validation Engineer

Santa Clara, California

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Today

Work Schedule Standard (Mon-Fri) Environmental Conditions Able to lift 40 lbs. without assistance, Adherence to all Good Manufacturing Practices (GMP) Safety Standards, Laboratory Setting, Office, Some degree of PPE (Personal Protective Equipment) required (safety glasses, gowning, gloves, lab coat, ear plugs etc.), Working at heights Job Description As a Staff Validation Engineer, you will play a key role in ensuring our bioprocessing equipment and TruBio software systems meet the highest st

Full-time

USD 112,500.00 - 187,500.00 per year

CSV System Assurance Lead

King of Prussia, Pennsylvania

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Yesterday

Job Title: CSV/GxP System Assurance Lead Location: King of Prussia, PA (Day-1 Onsite) Visa: No H1-B, OPT, CPT. Skills: CSV, CSA, GxP, FDA Compliance, GAMP, IQ/OQ/PQ, Risk Assessments, Change Management, Veeva, Argus, SAP Systems, MES, Serialization Systems, ALM, DMS, JIRA, Agile, Waterfall, Test Management, Validation Documentation, RTM, US-DSCSA Requirements 10+ years of experience in CSV and GxP validation for Life Sciences applications.Hands-on experience validating SAP Systems, MES, Serializ

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Contract

Depends on Experience

Controls Engineer

Billerica, Massachusetts

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Yesterday

Location: Billerica, MA Salary: $100,000.00 USD Annually - $120,000.00 USD Annually Description: Judge Direct Placement is seeking an Instrumentation & Controls Engineer for a national Engineering solutions client in the Boston suburbs! Responsibilities: Assist in design and troubleshooting of Instrumentation Controls systems for all mechanical and electrical issues including but not limited to PLCs, various motion controls, multi-axis servos, SCADA systems, AC/DC drives, electronics, PLC t

Contract

USD 100,000.00 - 120,000.00 per year

Senior Aveva OSI PI Engineer

Raritan, New Jersey

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4d ago

Senior Aveva OSI PI Engineer Raritan - NJ Contract Skill Matrix OSIsoft PI/ASPEN IP21 Software Development Must Have's: Pl Sr, Eng with Life Science domain experience - preferable at least 8 yrs About the role: We are looking for an Senior Aveva OSI PI Engineer to join our OSI team for a site-based project in New Jersey area. The Senior OSIsoft PI Software Engineer needs to have an in-depth experience of Aveva PI Data Historian Systems, Control Systems and Process Analysis. The successful candid

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Contract, Third Party

Depends on Experience

CSV Engineer

Seattle, Washington

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Today

CSV EngineerJPC - 6850Costa Mesa, CA or Seattle, WA(On-site) Key Responsibilities:Develop and maintain Design Specifications (DS) for computerized and automated systems.Author and execute Installation Qualification (IQ) and Operational Qualification (OQ) protocols.Generate and review validation reports and Validation Summary Reports (VSRs).Author and maintain Standard Operating Procedures (SOPs) for validated systems and equipment.Support implementation of CSV activities for IT and manufacturin

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Contract

Depends on Experience

Controls Engineer

Wilmington, Massachusetts

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4d ago

Full Time Role Please share Profiles at Hi, Urgent need, Controls Engineer Wilmington, MA JOB DESCRIPTION: We have a Controls Engineering position available in our Wilmington, MA office.This person will support controls engineering project requirements involving PLC programming, DCS programming, HMI/SCADA programming, database management, control panel design, instrumentation specification, engineering documentation support, check-out support and commissioning assistance.*Job Descriptions are n

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Full-time

$100,000 - $120,000

Computer System Validation Engineer

Bothell, Washington

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Yesterday

Job Title: Computer System Validation Engineer Location: Bothell, WA (50% Onsite) Duration: 6 Months Work Type: Hybrid (3 days a week onsite) and required to be onsite throughout UAT execution PURPOSE AND SCOPE OF POSITION: The Computer Systems Validation (CSV) Contractor works cross-functionally to lead and execute validation activities for GxP electronic systems and applications.This role is an individual contributor. The CSV Contractor will partner with Business Owners, Technical Owners, a

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Contract

$73 - $75

System Engineer

Rockville, Maryland

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Today

No C2C or subcontracting On-site in Rockville 2x per week Top Skills' Details 1. Azure, InTune, VMware, Hyper-V 2. Azure Backup implementation and optimization 3. Windows Server patching and ensure systems are up-to-date and secure 4. Sixth Sense (SYXSENSE) for cloud-based patching and endpoint management 5.Need someone strong in SAN or has led storage implementations 6. Microsoft Azure, Azure AD, Exchange Online, Teams, Office 365, SharePoint Online, PowerApps, Power BI. Description The System

Full-time

USD 40.00 - 55.00 per hour

System Assurance Lead

King of Prussia, Pennsylvania

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3d ago

We are looking for System Assurance Lead for our client in KOP, PA Job Title: System Assurance Lead Job Location: KOP, PA Job Type: Contract Job Description: Pay Range: $60hr - $65hrRequirement/Must Have: 10+ years of experience in validating systems and performing CSV activities in GxP-related applications such as LIMS, custom applications, AI, and innovative tools.Strong experience with Computer System Validation and Computer System Assurance.Proficiency in GAMP, GxP risk assessments, change

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Contract

Depends on Experience

Sr Level CSV Engineer

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

Validation Lead

Raritan, New Jersey

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25d ago

Job Title: Validation Lead Location: Raritan, NJ(Hybrid) Mandatory - Computer System Validation, IT Compliance Management Validating Clinical systems and/or clinical supplies and/or Safety and/or Manufacturing systems, CAPA Management, Periodic Review Job Description / Key Responsibilities: Oversee the testing phase of projects, ensuring that software and systems meet quality standards and business requirements. Has working experience in any one or two of the following domains - Clinical Devel

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Contract

$50 - $55

Operational Data Hub Engineer

Needham, Massachusetts

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23d ago

Title: Operational Data Hub (ODH) Engineer Regulatory Relevance: GxP The Role: Moderna is seeking a Principal Engineer, Data Systems to drive the evaluation, design, and delivery of the digital manufacturing data management technologies globally. The individual will lead strategic projects, evaluations, and customizations of the digital manufacturing systems. Activities will also include cross training of other digital manufacturing engineers. Key Responsibilities of the Position: List the Key R

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Contract, Third Party

$60 - $70

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

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+

CSV Engineer

Costa Mesa, California

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Yesterday

Job Code :- 6850-2-11/21 Hi Team, Please align the best possible resources ASAP. CSV Engineer Costa Mesa, CA or Seattle, WA(On-site) Visa: USC, GC & H4 EAD Key Responsibilities: Develop and maintain Design Specifications (DS) for computerized and automated systems. Author and execute Installation Qualification (IQ) and Operational Qualification (OQ) protocols. Generate and review validation reports and Validation Summary Reports (VSRs). Author and maintain Standard Operating Procedures (

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Contract

$55 - $60

Business Analyst

Clayton, North Carolina

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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

CSV Engineer

No location provided

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17d ago

Role :CSV Engineer Duration : Long Term Location :Bothell, WA(Day 1 onsite) Rate : $65/hr MaxMandatory Skill (MES - Manufacturing Execution System experience must) Job Description Responsible for preparing and executing test documentation for GMP computerized systems as well as providing support in the troubleshooting of issues during test execution.You should have excellent understanding of 21 CFR Part 11, ICH standards, EMA and FDA (GxP) regulations, and GAMP methodologies.Coordinate with mult

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Third Party, Contract

60 - 65

Controls Engineer (DeltaV)

Remote

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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

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