GAMP Jobs

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Automation Engineer

Jobot

•

Grand Rapids, Michigan, USA

Full-time

Automation Engineer Opportunity in Grand Rapids, MI! This Jobot Job is hosted by: David Chakmakjian Are you a fit? Easy Apply now by clicking the "Apply Now" button and sending us your resume. Salary: $80,000 - $105,000 per year A bit about us: Our client is a prominent contract development and manufacturing company, equipped with advanced technology and state-of-the-art equipment, providing tailored solutions to meet clients' fill and finish requirements for liquid vials, lyophilized vials,
Posted 1 day ago | Updated 1 hour ago

Infrastructure Qualification Validation Engineer (FACE-FACE Interview)

I.T. Solutions

•

Philadelphia, Pennsylvania, USA

Third Party, Contract

Qualification Engineer, Infrastructure Philadelphia, PA (FACE-FACE Interview) Type: Long term contract Length: 6 months to start, likely extensions Responsible for performing validation of computer systems, process automation, equipment, utility systems, and/or facilities by following approved standard operating procedures (SOPs), current Good Manufacturing Practices (GMPs) and all other regulatory requirements including GAMP5.Executes test plans according to approved procedures, collects sampl
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Posted 27 days ago | Updated 6 days ago

Computer System Validation Lead / CSV Lead

Radiansys, Inc.

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Remote

Full-time

Computer System Validation Lead / CSV Lead REMOTE / Work From Home Experience / Skills Responsibilities Improve the effectiveness and efficiency of the existing CSV delivery model through the creation of various templates, stools, training courses, and the periodic collection of KPI metricsProvide thought leadership for GMP Systems by working across different departments to deliver CSV-related programs, innovations, and communicationsContribute to the operational and process improvement initiati
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Posted 21 hours ago

eTMF / CQMS Business System Analyst

Blu Omega LLC

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Rockville, Maryland, USA

Full-time

Blu Omega is a Woman Owned Small Business IT services firm located in Washington DC and supporting clients nationally. We provide Technology solutions for enterprise and government customers. Our team has a past performance in a diverse range of programs including those for Data Management, Cloud/Infrastructure, Software Development and Enterprise Applications. We are seeking a Business Systems Analyst who specializes in eTMF systems to support a growing team within HHS. Overview: Are you lookin
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Posted 14 days ago | Updated 14 days ago

Senior Manager of Quality Management Systems (QMS) Operations

Johnson & Johnson

•

Raritan, New Jersey, USA

Full-time

Johnson & Johnson is recruiting for a Senior Manager of Quality Management Systems (QMS) Operations! This position can be performed at any J&J Site in North America, with a preference for Raritan, NJ. 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 Medici
Posted 1 day ago | Updated 1 hour ago

CSV Engineer

Cloud Bridge Solutions

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Massachusetts, USA

Contract

Responsibilities: Draft and implement Quality System documentation designed to establish good validation practices within the organization.Author URS, FRS, Risk Assessments, Configuration specification, design specification and CSV test protocols and execute them in compliance with GDP guidelines and internal quality standards.Author and develop SOP and VMP for computer system validation for manufacturing equipment.Design validation approaches, supported by appropriate statistical analyses, perf
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Posted 20 days ago | Updated 20 days ago

Automation Engineer

ABEC Inc

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Bethlehem, Pennsylvania, USA

Full-time

This is a full time onsite role at our Bethlehem facility. NOTE: A Bachelor's Degree in Electrical Engineering or related discipline or equivalent industrial platform automation related job experience is required for this position. Company Overview: ABEC is a leading supplier to the biopharmaceutical manufacturing industry. ABEC's unique value is based on combining long experience with the ability to engineer, design, manufacture, commission, qualify, and service the entire bioprocess to redu
Posted 18 hours ago

Computer System Validation Engineer

HAYS

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Washington, USA

Contract

Computer System Validation Engineer - Contract - Bothell, WA \ Hybrid - $66.00 - $76.00/hr. The final salary or hourly wage, as applicable, paid to each candidate/applicant for this position is ultimately dependent on a variety of factors, including, but not limited to, the candidate's/applicant's qualifications, skills, and level of experience as well as the geographical location of the position. Applicants must be legally authorized to work in the United States. Sponsorship not available. O
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Posted 31 days ago | Updated 1 hour ago

Quality - Sr. Manager, Data Integrity

Futran Solutions

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Bothell, Washington, USA

Full-time

Job Description: PURPOSE AND SCOPE OF POSITION: This position reports into the Quality Assurance department and is responsible for assisting with the implementation and management of BMS's GMP Data Governance and Data Integrity program at the Bothell, WA manufacturing facility. REQUIRED COMPETENCIES: Knowledge, Skills, and Abilities: Education: BS or higher degree in an IT, engineering, scientific discipline, or other related field. Experience: Eight (8) or more years of relevant work experie
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Posted 15 days ago | Updated 4 days ago

Computer Software Validation (CSV) Consultant

Beacon Hill Life Sciences - Boston

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Canton, Massachusetts, USA

Full-time

Job DescriptionJob DescriptionPosition Overview: We are seeking a highly experienced Computer Software Validation Contractor with 5 years of hands-on experience in lab and analytical software. The ideal candidate will possess a deep understanding of software validation principles and methodologies, with a specific focus on ensuring compliance within regulated environments. Key Responsibilities: Software Validation: Execute validation activities for laboratory and analytical software systems, ens
Posted 27 days ago | Updated 1 hour ago

Computer System Validation Associate

KVK Tech

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Newtown, Pennsylvania, USA

Full-time

Job DescriptionJob DescriptionDepartment Information Systems Job Title Computer System Validation Associate FLSA Status: Exempt Reports To Director of Information Systems and Procurement 1. Role Purpose: CSV Associate will work as help desk staff for other cross functional teams as appropriate to determine and resolve problems. The CSV Associate will respond to queries, isolated problems and determine and implement solutions. Perform daily system monitoring to ensure that all computer-based syst
Posted 2 hours ago

Sr Engineer II, Automation

Biogen

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North Carolina, USA

Full-time

Job DescriptionJob DescriptionJob Description The Sr. Automation Engineer II maintains and troubleshoots all process control system hardware and software (DeltaV DCS system) in support of the biopharmaceutical manufacturing process. Creates software design specifications, implements new control strategies and develops software test protocols in support of new products and processes. The ideal candidate is fluent with various other Automation systems including Data Historian (OSI PI), Data Acqu
Posted 2 hours ago

Validation Manager

Biosimilar Sciences PR LLC

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Aguadilla, Aguadilla, Puerto Rico

Full-time

Job DescriptionJob DescriptionJob Title: Validation Manager About Ocyonbio: Ocyonbio is a biotechnology company based in Aguadilla, Puerto Rico, dedicated to propelling the future of healthcare. We provide cGMP spaces that can be customized to meet unique requirements and services to help catalyze the development, manufacturing, and commercialization of biologics, genetic, and cellular therapies. We behave more like a cGMP incubator space with all regulatory, systems capabilities, and resources
Posted 10 days ago | Updated 1 hour ago

Quality Specialist II - MODA Administrator

Civica Rx

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Petersburg, Virginia, USA

Full-time

About Civica Civica is a 501(c)(4) social welfare organization established in 2018 by health systems and philanthropies to reduce chronic generic drug shortages and related high prices in the United States. Civica is led by an experienced team of healthcare and pharmaceutical industry leaders. Today, more than 55 health systems have joined Civica. They represent over 1,500 hospitals and one-third of all U.S. hospital beds. Civica has also begun to supply the U.S. Department of Veteran's Affairs
Posted 19 days ago | Updated 1 day ago

Quality Assurance Validation Manager

Ascend Advanced Therapies

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Alachua, Florida, USA

Full-time

Job DescriptionJob DescriptionTitle: Quality Assurance Validation Manager Location: Alachua, Florida Reporting to: Director of Quality Assurance Ascend is pioneering the future of healthcare through relentless innovation, our forward-thinking company is on a mission to manufacture safe, efficacious, and scalable gene therapies. Our vision is to set a new standard for gene therapy manufacturing through continuous scientific and process innovation. Our teams, rooted in biopharma, possess regulato
Posted 14 days ago | Updated 1 hour ago

GxP Validation Engineer/Analyst (Lab Equipment)

WHITE COLLAR TECHNOLOGIES INC

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Cambridge, Massachusetts, USA

Full-time

Job DescriptionJob DescriptionResponsibilities: Provide support to the QC Analytical department for activities required to maintain CGMP status of QC Instrumentation hardware and software and to perform comparability studies for the implementation of analytical assays on new instrumentation. This scope includes QC Instruments (both portable and computer-controlled). Authoring Corrective & Preventive Action plans (CAPAs) for systems with long-term remediation activities, and authoring final repor
Posted 27 days ago | Updated 1 hour ago

AUTOMATION & VALIDATION ENGINEER 1

JSAT AUTOMATION INC

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Glendale, California, USA

Full-time

Job DescriptionJob Description Job Responsibilities Design and develop manufacturing control systems in support of process operations. Interact with client personnel to identify and analyze continuous improvement through automation upgrades. Develop validation documents per FDA cGMP and GAMP standards, functional specifications, design specifications and requirements trace matrices. Design, program, test and validate process control automation systems. Prepare and execute validation protocols (A
Posted moments ago

AUTOMATION & VALIDATION ENGINEER

JSAT AUTOMATION INC

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San Diego, California, USA

Full-time

Job DescriptionJob Description Job Responsibilities Design and develop manufacturing control systems in support of process operations. Interact with client personnel to identify and analyze continuous improvement through automation upgrades. Develop validation documents per FDA cGMP and GAMP standards, functional specifications, design specifications and requirements trace matrices. Design, program, test and validate process control automation systems. Prepare and execute validation protocols (A
Posted moments ago

Senior Manager Customer Success

Maxis Clinical Sciences

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Edison, New Jersey, USA

Full-time

Job DescriptionJob DescriptionJob Requirements& Responsibilities: Experience working with Pharma / Clinical Development / eClinical software products and services is required.Experience in Clinical Data Repository/Warehouse (CDR/CDW) and Metadata Repository is an advantage.Must have knowledge and experience with emerging regulations for the Life Sciences industry E.g. 21 CFR 11, 21 CFR 211, 21 CFR 820, EU Annex 11Must have experience in qualification, testing, and validation approaches aligned w
Posted 27 days ago | Updated 2 hours ago

Sr. Automation Engineer

CPMNA

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College Station, Texas, USA

Full-time

Job DescriptionJob DescriptionSalary: The Senior Automation Engineer provides technical support and accountability for the execution of capital projects that are critical to the success of our business. The Senior Automation Engineer will participate in the development, installation, operation, maintenance, and repair of all automation systems to meet organizational goals and objectives. This position will also work closely with other operators, calibration technicians and engineers to maintain
Posted 10 days ago | Updated 1 hour ago