- Leading start-up, commissioning, qualification, validation and revalidation projects for facility, equipment, critical utility, automation/computer system, cleaning, sterilization, medical device, and drug product manufacturing processes.
- Leading the delivery of validation within complex, capital projects overseeing engineering, quality, and compliance aspects of validation.
- Authoring, executing, and summarizing qualification and validation protocols.
- Conducting Risk / Impact assessments and establishing system boundaries.
- Ensuring protocols, records, and procedures are in compliance with current Good Manufacturing Practices (cGMP), industry standards and approved SOPs.
- Coordinating the investigation and impact assessment for all deviated equipment or processes discovered upon calibration or validation.
- Initiating and/or providing validation input on quality systems such as CAPAs and change controls.
- Responsible for other duties and projects as assigned.
- Minimum 8+ years of cleaning validation experience in pharmaceutical, medical device or FDA regulated environments.
- Strong understanding of cGMP and regulations related to facility, utility, equipment, and process validations.
- Ability to initiate, manage and close quality systems such as change control, CAPA and deviation management.
- Detailed experience performing root cause analysis investigations for deviations and non-conformances having technical scope.
- Excellent written and verbal communications skills.
- Solid understanding of quality risk management principles and statistical concepts as applicable to area of responsibility.
- Subject matter expert on regulations and best practices pertaining to validation.
- Practical application and knowledge of ISO 13485, GHTF Process Validation Guidance and other applicable standards used in the medical device manufacturing.
- B.S. degree in Engineering or related discipline
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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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Senior Validation Engineer
3 weeks ago
a Medical Devices company in MA Bedford, United StatesRESPONSIBILITIES · Continuously improving the design of automated systems, execution, and automation processes. · Collaborating effectively with Process Engineering, Operations, Quality, and Validation departments on an ongoing basis. · Communicating automation-related issues and ...
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Validation Engineer – Process Validation
2 weeks ago
Shire Human Genetic Therapies, Inc Lexington, United StatesShire 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, $152,200. ...
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Validation Engineer III
4 weeks ago
Anika Corporation Bedford, United StatesSummary of Primary Responsibilities: · Leads start-up, commissioning, qualification, validation and revalidation projects for facility, equipment, critical utility, automation/computer system, cleaning, sterilization, medical device, and drug product manufacturing processes. · ...
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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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Validation Engineer III
3 weeks ago
Anika Corporation Bedford, United StatesSummary of Primary Responsibilities: · Leads start-up, commissioning, qualification, validation and revalidation projects for facility, equipment, critical utility, automation/computer system, cleaning, sterilization, medical device, and drug product manufacturing processes. · ...
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Senior Validation Engineer
3 weeks ago
DPS Group Global Bedford, United StatesSummary · The CQV Engineer is responsible for executing and managing equipment, facility, utility, process, primary packaging validation activities and change management activities to meet cGMP requirements. They will need experience with cleaning validation of syringe filling m ...
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Validation Engineer
2 weeks ago
Entegee Billerica, United StatesJob Description · Job DescriptionSummary: Seeking a Process Development Engineer II to develop and validate new manufacturing processes and equipment, manage development builds, and drive continuous yield improvements in a production setting. · Must Haves: · BS in Mechanical Engi ...
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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 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
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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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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Staff NPI and Validation Engineer
2 weeks ago
Insulet Corporation Acton, United States Full timeInsulet started in 2000 with an idea and a mission to enable our customers to enjoy simplicity, freedom and healthier lives through the use of our Omnipod product platform. In the last two decades we have improved the lives of hundreds of thousands of patients by using innovative ...
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Validation Engineer I
3 weeks ago
Top Tool Company Lowell, United StatesCirtec Medical · - is more than just another design shop or contract manufacturer, we offer a uniquely comprehensive range of vertically integrated capabilities. Cirtec Medical specializes in complex, difficult to produce components and devices in today's most advanced product t ...
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Validation Engineer I
2 weeks ago
Cirtec Medical Corporation Lowell, United StatesJob Description · Job DescriptionCAREERS WITH AN IMPACT · Cirtec Medical - is more than just another design shop or contract manufacturer, we offer a uniquely comprehensive range of vertically integrated capabilities. Cirtec Medical specializes in complex, difficult to produce co ...
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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 ...
Sr. Cleaning Validation Engineer - Bedford, United States - a Medical Devices company in MA
3 weeks ago
Description
Senior Validation Engineer
RESPONSIBILITIES
RESPONSIBILITIES
EDUCATION