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Validation Engineer CSV
1 week ago
BlueSky Innovations Tremont City, United StatesWe, the Dr. Franz Köhler Chemie GmbH, are a research-intensive and innovative pharmaceutical company in its third generation with two locations in Bensheim and Alsbach. With a highly specialized portfolio of niche products that require extensive expertise and a great deal of resp ...
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Validation Engineer
3 weeks ago
Katalyst Healthcares and Life Sciences Cambridge, United StatesResponsibilities: Collaborate with stakeholders to gather and define requirements for validation activities · Design and execute validation protocols, including Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ) · Perform risk as ...
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Validation Engineer
2 days ago
Katalyst Healthcares and Life Sciences Cambridge, United StatesResponsibilities: Provide validation subject matter expertise / support for equipment and systems in use at Client site which includes Analytical Instruments, Manufacturing Operation Units and CTUs (Controlled Temperature Units). · Ensure the validated status of site facilities, ...
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Engineer III, Validation
3 weeks ago
Thermo Fisher Scientific Cambridge, United States OTHERJob Description · DUTIES: · Plan and execute validation projects including working with the Thermo Fisher core teams to understand the scope of validation activities and develop schedule, budget, resource plans to meet overall project objectives; · Act as a subject matter expert ...
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Validation Engineer
2 weeks ago
Katalyst HealthCares & Life Sciences Cambridge, United StatesResponsibilities: Collaborate with stakeholders to gather and define requirements for validation activities · Design and execute validation protocols, including Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ) · Perform risk a ...
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Validation engineer
3 weeks ago
techscienceinfo llc Boston, United StatesRole : Validation engineer · Job Description: · KEY AREAS OF JOB ACCOUNTABILITY: (list of key objectives and quantifying standards): · The holder of this position is charged with supporting computer system/computerized equipment validation activities and ensuring compliance with ...
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Validation Engineer
2 weeks ago
GQR Waltham, United StatesTitle: Validation Engineer (CSV) · Location: Waltham, MA · Status: 6-month contract · Hourly rate: $60 · Please note that this role is not able to provide sponsorship or work on a C2C basis. · Position Overview: · The Computer System Validation Specialist will support the validat ...
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Validation Engineer
1 week ago
GQR Waltham, United StatesTitle: Validation Engineer (CSV) · Location: Waltham, MA · Status: 6-month contract · Hourly rate: $60 · Please note that this role is not able to provide sponsorship or work on a C2C basis. · Position Overview: · The Computer System Validation Specialist will support the valid ...
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Model Validation Analyst III
2 weeks ago
Extreme Event Solutions Boston, United StatesJob Description · Job DescriptionCompany Description · We help the world see new possibilities and inspire change for better tomorrows. Our analytic solutions bridge content, data, and analytics to help business, people, and society become stronger, more resilient, and sustainabl ...
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Validation Engineering
4 weeks ago
CyberCoders Boston, MA, United StatesPortland, OR · • Santa Clara, CA · • Austin, TX · • Boston, MA · • Phoenix, AZRemote Available Full-time $150,000.00Posted 04/04/2024Job Title: REMOTE Sr. Formal Verification Engineer - CPUJob Location: REMOTE - preference for Portland, OR or Vancouver (Canada)Compensation: $ ...
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Validation Engineer
3 weeks ago
VASTEK GROUP INC Boston, United States Full timeThis individual assures validation activities are performed in conformance with applicable Standard Operating Procedures (SOPs) client standards industry best practices and regulatory requirements. The individual performs validation program-related activities such as DQ COM IQ OQ ...
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Validation Engineer
1 week ago
GQR Watertown, United StatesTitle: Validation Engineer (CSV) · Location: Waltham, MA · Status: 6-month contract · Hourly rate: $60 · Please note that this role is not able to provide sponsorship or work on a C2C basis. · Position Overview: · The Computer System Validation Specialist will support the v ...
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Validation Engineer
6 days ago
Shire Human Genetic Therapies, Inc San Francisco, United States PermanentShire Human Genetic Therapies, Inc. is seeking a Validation Engineer - · Process Validation in Lexington, MA to provide validation support for Shire biologics manufacturing operations located in Lexington and Cambridge. Up to 40% remote work allowed. · Full time. $130, - $152, ...
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Engineer III, Validation
3 weeks ago
Thermo Fisher Scientific Cambridge, United StatesDUTIES:Plan and execute validation projects including working with the Thermo Fisher core teams to understand the scope of validation activities and develop schedule, budget, resource plans to meet overall project objectives;Act as a subject matter e Validation, Mechanical Engine ...
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Engineer III, Validation
3 weeks ago
Thermo Fisher Scientific Cambridge, United StatesJob Description · DUTIES: · Plan and execute validation projects including working with the Thermo Fisher core teams to understand the scope of validation activities and develop schedule, budget, resource plans to meet overall project objectives; · Act as a subject matter expert ...
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Engineer III, Validation
4 weeks ago
Thermo Fisher Scientific Cambridge, United StatesJob Description · DUTIES: · Plan and execute validation projects including working with the Thermo Fisher core teams to understand the scope of validation activities and develop schedule, budget, resource plans to meet overall project objectives; · Act as a subject matter expe ...
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Senior Model Validation Analyst II
2 weeks ago
Extreme Event Solutions Boston, United StatesJob Description · Job DescriptionCompany Description · We help the world see new possibilities and inspire change for better tomorrows. Our analytic solutions bridge content, data, and analytics to help business, people, and society become stronger, more resilient, and sustainabl ...
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Financial Model Validation Analyst III
2 weeks ago
Extreme Event Solutions Boston, United StatesJob Description · Job DescriptionCompany Description · We help the world see new possibilities and inspire change for better tomorrows. Our analytic solutions bridge content, data, and analytics to help business, people, and society become stronger, more resilient, and sustainabl ...
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Payment Validation Analyst
6 days ago
Element Care Lynn, United StatesThe Payment Validation Analyst evaluates claim issues due to billing errors, coding edits, rejections, denials, and payment variances. This position is responsible for updating payment system with rate changes and performing data validation. · ESSENTIAL RESPONSIBILITIES: · Updat ...
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Payment Validation Analyst
3 weeks ago
Element Care Lynn, United StatesThe Payment Validation Analyst evaluates claim issues due to billing errors, coding edits, rejections, denials, and payment variances. This position is responsible for updating payment system with rate changes and performing data validation. · ESSENTIAL RESPONSIBILITIES: · Updat ...
GxP Validation Engineer/Analyst - Cambridge, United States - WHITE COLLAR TECHNOLOGIES INC
Description
Job Description
Job 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 reports for systems with short-term/completed remediation
· Performing supporting remediation work in the form of SOP revisions
· Executing change controls and validation test plans/protocols when required per remediation plans
· Responsible for the development and execution of general deliverables, such as Risk Assessments, Validation Plans, Change Impact Assessments, Design Specifications, User Requirements, Functional Requirements, Configuration Specification, Requirement Trace Matrices, IQ/OQ/UAT/PQ Protocols, and Summary Reports.
Desired Skills and Experience:
· Author, maintain, revise, and/or approve of the Validation Plan.
· Lead the resolution of deviations noted during protocol execution.
· Manage and approve vendor's documentation as appropriate.
· Ability to impact and influence people/areas in matters related to Validation and GxP compliance.
· Ability to work in a fast-moving dynamic small company environment.
· Ability to mentor junior team members.
· Experiences in other validation areas which may include CSV qualification and Facility Equipment and Utility is a plus.
Required Qualifications:
· Validation experience in a biotech/pharmaceutical environment, specializing in Instrument or Computer System Validation
· Bachelor's Degree in Engineering, Life Science or Computer Science is required.
· Excellent working knowledge of process automation and computer system validation concepts, GAMP methodologies, CFR Part 11 Electronic Records and Signatures requirements and latest industry expectations for data integrity.
Company DescriptionWhite Collar Technologies is a boutique human capital consultancy firm specializing in information technology and engineering consulting for life science sector. Our consultants serve multitude of clients within Pharmaceutical, Biotech, Medical Device, Clinical Research and Healthcare verticals.We offer our workers Medical Dental and Vision healthcare benefits.
Company Description
White Collar Technologies is a boutique human capital consultancy firm specializing in information technology and engineering consulting for life science sector. Our consultants serve multitude of clients within Pharmaceutical, Biotech, Medical Device, Clinical Research and Healthcare verticals.\rWe offer our workers Medical Dental and Vision healthcare benefits.