- Writes and executes commissioning qualification & validation protocols for facilities utilities equipment and computerized systems
- Writes final reports
- Resolves protocol discrepancies and deviations
- Reviews vendor-generated validation protocol packages
- Supports change control deliverables
- Responsible for the generation of complex protocols using a risk-based approach that meets current regulatory requirements and industry practicesRequirements
- Minimum of 0-1 year of experience.
- BS/MS in Mechanical/Industrial/Manufacturing/Biology/Chemical/Biochemistry/Biomedical Engineering.
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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
4 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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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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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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GxP Validation Engineer/Analyst
3 weeks ago
WHITE COLLAR TECHNOLOGIES INC Cambridge, United StatesJob 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 ...
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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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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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Validation Engineer
6 days ago
Catalyx North America Andover, United StatesCatalyx is planning demolition and decommissioning at a client site of the existing Suite E UF Skid and TK3017 Wash Tank, which will include the equipment, process & utility piping, control wiring, and electrical power wiring. As part of this project, the UF skid will be upsized ...
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Validation Engineer
1 week 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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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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Design Validation Engineer
4 days ago
GCR Professional Services Cambridge, MA, United StatesSr. Digital Design Verification Engineer · Direct Hire · FTE, Full Benefits... Hybrid, Onsite Cambridge, MA · Security Requirement: · The ability to obtain a US secret clearance is required which requires proof of US citizenship Active secret clearance is preferred · Digital Des ...
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Validation Engineer
1 week ago
Kelly Science, Engineering, Technology & Telecom Marlborough, United StatesJob Title: Validation Engineer · Pay rate: $71.42 per hour · Duration: 06 months · W2 contract only (No C2C) · Location- Marlborough, MA, 01752 · Description · The Validation Engineer (Mid Level) will be responsible for leading the verification and validation efforts on various ...
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Validation Engineer
2 days ago
Katalyst HealthCares & Life Sciences Hopkinton, United StatesRoles & Responsibilities: · Perform equipment and system validations. · Develop, review, and approve accurate documentation, as required in cGMP operations. · Provide responsive customer support with emphasis on customer satisfaction. · Work in a collaborative team environment an ...
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QMS Software Validation Engineer
4 days ago
Philips Cambridge, United StatesLooking at the challenges the world is facing today Philips purpose has never been more relevant. So, whatever your role, if you share our passion for helping others, youll be working towards creating a better and fairer future for all. · In this role you have the opportunity to ...
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validation Engineer
1 week ago
Advantage Technical Waltham, United StatesValidation Engineer · Terrific hybrid opportunity to join a growing local pharmaceutical company. We are seeking a Program Manager to join our dynamic team in Waltham, MA. Come and build a satisfying career with our world class staff. We offer a competitive salary, annual bonuse ...
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QMS Software Validation Engineer
3 days ago
Philips Cambridge, United States Full timeJob Title · QMS Software Validation EngineerJob Description · Looking at the challenges the world is facing today Philips' purpose has never been more relevant. So, whatever your role, if you share our passion for helping others, you'll be working towards creating a better and fa ...
Validation Engineer - Boston, United States - VASTEK GROUP INC
Description
This 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 PQ CQ RQ etc.Essential Duties and Responsibilities