- BS in a Computer Science or Engineering field or equivalent experience
- 5-15 years experience with Computer systems validation, including experience in authoring/reviewing/approving validation documentation (URS, Risk Assessment, IQ/OQ/PQ)
- Strong background and understanding of FDA regulations
- Deep 21CFR Part 11 experience is preferred
- Knowledge and experience with GAMP5 Risk Based Approach to GxP Computerized Systems and risk assessment method is preferred
- Provide inputs supporting creation of computer system related policies, procedures, templates, forms, etc.
- Review/assess computer system change controls, discrepancies, CAPAs
- Review and provide feedback to vendor validation documentations (validation plans, executed protocols, risk assessments, etc.)
- Works closely with the QA function to provide expertise in CSV compliance, manage identified issues, and support continuous improvement
- Support inspection readiness programs and/or directly support regulatory agency inspections. Assist in the coordination of response to any findings as applicable.
- Develop and evaluate quality processes and system standards to ensure compliance with applicable procedures, industry standards and global regulations.
- Experience with validation and operation of the following preferred: TrackWise, LabWare LIMS, Software as a Service (SaaS), DocuSign, PLC, automated manufacturing systems.
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CSV Engineer
2 weeks ago
Katalyst HealthCares & Life Sciences Boston, United StatesRoles & 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 co ...
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CSV Engineer
2 weeks ago
Trinity Consultants Boston, United StatesCSV Engineer · This is a hybrid role in the Boston area. Only candidates with Biopharmaceutical experience will be contacted. · ADVENT Engineering is an engineering and consulting firm providing expertise to the pharmaceutical and biotechnology industries. Headquartered near Sa ...
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CSV Engineer I
4 weeks ago
uniQure Boston, United StatesCSV Engineer I / II · Location: · Lexington, 113 Hartwell Ave · Education level: · Bachelor / Graduate · Job category: · Engineering · Target start date: · 6/10/2024 · Work Location: · On-Site · Shift: · 1st · uniQure is dedicated to bringing therapies for unmet medi ...
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CSV Engineer I
3 weeks ago
uniQure Boston, United StatesCSV Engineer I / II · Location: · Lexington, 113 Hartwell Ave · Education level: · Bachelor / Graduate · Job category: · Engineering · Target start date: · 6/10/2024 · Work Location: · On-Site · Shift: · 1st · uniQure is dedicated to bringing therapies for unmet medical needs ...
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Sr CSV Engineer
3 weeks ago
Maxis Clinical Sciences Boston, United StatesJob Description · Job Description · Senior Validation Consultant · Must have experience with EDC Validation. · Job Description: · Providing support in Quality Assurance process awareness and adherence and supporting in preparation/review process related documents like SOP's (S ...
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CQV Engineer
1 week ago
DPS Group Global Boston, United StatesSummary · Arcadis DPS Group Global is seeking a highly skilled CQV Engineer with specialized expertise in qualifying filling line isolators for biotech and pharmaceutical applications. The ideal candidate will play a key role in ensuring the reliability, efficiency, and complian ...
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IT Project Manager
3 weeks ago
Saxon Global Boston, United StatesTitle : IT Project Manager · Company: Parma · Basic Company Info: The Medical Research Institute is organization dedicated to the development and effective use of novel biomedical interventions addressing substantial global health concerns, for which investment incentives are l ...
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Senior Integration Engineer
3 weeks ago
Roberts Recruiting Boston, United StatesSenior Integration Engineer · Job Description · Our Global Cybersecurity Services is seeking a system and data integration expert to join our Engineering & Architecture group. You will be involved in building and managing integrations and components that strengthen our enterpri ...
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CSV Specialist
2 weeks ago
Mentor Technical Group Boston, United StatesMentor Technical Group (MTG) provides a comprehensive portfolio of technical support and solutions for the FDA-regulated industry. As a world leader in life science engineering and technical solutions, MTG has the knowledge and experience to ensure compliance with pharmaceutical, ...
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customer support engineer
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Coin Metrics Boston, United States**CUSTOMER SUPPORT ENGINEER** · at Coin Metrics Remote- US, Boston, Massachusetts, United States Coin Metrics is a leading provider of cryptoasset data for institutions. We deliver transparent and actionable data and analytics to various industry stakeholders including asset man ...
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CQV Engineer
3 weeks ago
DPS Group Global Boston, United StatesSummary · The successful candidate will primarily be responsible for validating existing manufacturing equipment and processes as the company prepares to begin clinical development. In addition, he/she will plan and implement continuous improvement initiatives, ensure design for ...
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CQV Engineer
3 weeks ago
Katalyst HealthCares & Life Sciences Boston, United StatesResponsibilities: · Draft and implement Quality System documentation designed to establish good validation practices within the organization. · Author URS, IQ, OQ and PQ protocols and execute them in compliance with GDP guidelines and internal quality standards. · Design valid ...
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Senior Process Engineer
3 weeks ago
Katalyst Healthcares and Life Sciences Boston, United StatesResponsibilities: Execute change management for manufacturing equipment and other support systems including commissioning and/or implementation of other related initiatives as assigned. Execute assigned duties on time and within budget; pro-actively communicate delays and other i ...
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CQV Engineer
3 weeks ago
PES International Boston, United StatesCQV Engineer · Pharmaceutical & Life Sciences · Company: PES International · Location: Boston, MA · Compensation: Commensurate with Experience · About this opportunity: · PES International is an international industry leader in providing automation, commissioning, qualifi ...
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GIS Technician
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CQV Engineer
3 weeks ago
DPS Group LLC Boston, United StatesSummary · Arcadis DPS Group Global is seeking a highly skilled CQV Engineer with specialized expertise in qualifying filling line isolators for biotech and pharmaceutical applications. The ideal candidate will play a key role in ensuring the reliability, efficiency, and complia ...
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Senior Integration Engineer
3 weeks ago
Roberts Recruiting Boston, United StatesSenior Integration Engineer · Job Description · Our Global Cybersecurity Services is seeking a system and data integration expert to join our Engineering & Architecture group. You will be involved in building and managing integrations and components that strengthen our enterpri ...
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Lead Quality Engineer
3 weeks ago
OPT Industries Boston, United StatesCompany Description : · OPT Industries ) is a rapidly growing, venture-backed MIT spinoff company that focuses on building the next generation of additive manufacturing technology. Working at the intersection of automation engineering, computational design, and polymer science, ...
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Lead Quality Engineer
3 weeks ago
OPT Industries Boston, United StatesCompany Description: · OPT Industries ) is a rapidly growing, venture-backed MIT spinoff company that focuses on building the next generation of additive manufacturing technology. Working at the intersection of automation engineering, computational design, and polymer science, w ...
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Senior Solutions Architect
4 weeks ago
LanceSoft Boston, United StatesResponsibilities · Analyze cloud technology footprint and provide "right-sizing" recommendations based on cost and performance · Architect cloud-hosted and cloud-native solutions to modernize an aging application portfolio · Identify SaaS solutions to meet business needs · Util ...
CSV Engineer - Boston, United States - Trinity Consultants
Description
CSV Engineer
This is a hybrid role in the Boston area. Only candidates with Biopharmaceutical experience will be contacted.
ADVENT Engineering is an engineering and consulting firm providing expertise to the pharmaceutical and biotechnology industries. Headquartered near San Francisco, California, and with operations in the Eastern and Western US, Canada and Singapore, our company is involved in almost every facet of global pharmaceutical and biotechnology facility design and process engineering and quality system projects.
ADVENT's services include process engineering, automation engineering, project engineering, HVAC/facility system design, process development, start up and commissioning, validation and compliance consulting for distinguished and successful biotechnology and pharmaceutical manufacturing companies.
This is an outstanding opportunity to join our growing team
Position Description
The Computer Systems Validation (CSV) Engineer will perform validation activities in support of GMP computerized systems. Examples include EDMS, Trackwise, LIMS, and automated manufacturing systems. The position requires development and/or execution of requirements specifications, configuration specifications, Installation Qualification (IQ) protocols, Operational Qualification (OQ) protocols, Performance Qualification (PQ) protocols including collaboration, oversight, test execution, discrepancy/deviation management, and generating final reports. The job also requires representing validation interests on project teams, interacting with vendors, contractors, overseeing preparation of validation change control request records, and conducting periodic reviews.
Position Requirements