Email Alert for
ⓘ There was an unexpected error processing your request.
Please refresh the page and try again.
If the problem persists, please contact us with your issue.
You can always manage your preferences and update your interests to ensure you receive the most relevant opportunities.
Get ready to discover your next great opportunity.
DPS Group Global
Norwood, MA, United States
Summary DPS Group is seeking an enthusiastic and experienced computer system validation engineer to join our team. The Computer System Validation Engineer will be responsible for the Computer System Validation of IT solutions being implemented for a continuous manufacturing facility. The Computer System Validation Engineer will provide IT systems v
Job Source: DPS Group GlobaluniQure
Boston, MA, United States
CSV 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 to patients. Each position at uniQure is directly or indirectly responsible to improving the li
Job Source: uniQureMentor Technical Group
Boston, MA, United States
Mentor 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, biotechnology, and medical device safety and efficacy guidelines. Wit
Job Source: Mentor Technical GroupMentor Technical Group
Boston
Job Description Job Description Mentor 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, biotechnology, and medical device
Job Source: Mentor Technical GroupMASSACHUSETTS MARITIME ACADEMY
Boston, MA, United States
Sequoia is seeking an Associate Validation Engineer to assist with the development and execution of validation protocols for various types processes. The Validation Engineer will be responsible for driving overall quality performance and compliance throughout the organization by defining, implementing and maintaining the validation program. Respons
Job Source: MASSACHUSETTS MARITIME ACADEMYBeacon Hill
Canton, MA, United States
To Apply for this Job Click Here Position 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
Job Source: Beacon HillQ1 Technologies Inc.
Boston
GXP Documentation Specialist Must Have Lab CSV GxP validation plan and execution experience. * Experience in Life Sciences domain * Specialist in creating GxP documentation * Hands on experience in procedure and process documentation creation * Hands on experienc...
Job Source: Q1 Technologies Inc.Digital Prospectors
Lexington, MA, United States
Digital Prospectors Senior Lab IT Consultant Lexington , Massachusetts Apply Now Phone: 603.609.7082 Position: Senior Lab Information Technology Consultant Location: Lexington, MA (Hybrid – 3 days onsite) Length: 12+ months Job Description: Our client is looking for a Senior Lab Information Technology Consultant to support ongoin
Job Source: Digital ProspectorsBoston, MA, United States
CSV Engineer
Boston/Rhode Island
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, perform and/or coordinate all validation activities, analyze and assemble results, and draft validation reports.
Provide input on user and/or functional requirements of current and future processing equipment, and draft appropriate documentation. Additionally, interface with Contract Manufacturers to ensure all relevant user and functional requirements are met.
Provide support to non-engineering Staff, including those from R&D and Manufacturing, to ensure successful technology transfer and continuous improvement.
Execute assigned duties on time and pro-actively telegraph delays and other issues to validation manager and other relevant stakeholders.
Comply with all regulatory, corporate, and Quality System policies
Qualifications:
B.S. / M.S. in engineering or another relevant discipline.
Minimum of 5+ years of experience working within a medical device environment or other FDA regulated environments. Experience with device-biologic combination products is highly desirable.
Experience in the areas of Design Documentation (URS, FRS, CS, DS, and other engineering specifications) and Validation (OQ, CSV, etc.),
Understanding of c.G.x.P principles and familiarization with ISO 13485, ISO 14971, and 21C.F.R.820
Experience with 21 CFR Part 11 and Data Integrity.
Working knowledge GAMP 4 and GAMP 5 categorization and their respective deliverables for Computer Systems Validation lifecycle.
Proficient in Microsoft Word, Excel, PowerPoint.
Must be able to work independently with adequate supervision, multi-task, and support several projects simultaneously.
Must demonstrate strong communication, interpersonal and teamwork skills.
A strong understanding of technical writing and presentation skills is required.
#J-18808-Ljbffr
Email Alert for CSV Engineer jobs in Boston, MA, United States
ⓘ There was an unexpected error processing your request.
Please refresh the page and try again.
If the problem persists, please contact us with your issue.
You can always manage your preferences and update your interests to ensure you receive the most relevant opportunities.
Get ready to discover your next great opportunity.