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.
Trinity Consultants
Boston, 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 qual
Job Source: Trinity ConsultantsDPS 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 GlobalMentor 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 HillHealthEdge Software Inc
Boston
**Overview** **JOB TITLE: Data Integrations Analyst II** **JOB LOCATION: Reports to office in Reston, VA 20191. REMOTE EMPLOYMENT IS AVAILABLE. TELECOMMUTING FROM ANY LOCATION IN THE UNITED STATES IS POSSIBLE FOR THIS POSITION.** **REPORTS TO: Lead, Data Integrations Analyst** **POSITION SUMMARY:** The Data Integrations Analyst II plays a key role
Job Source: HealthEdge Software IncHealthEdge
Boston, MA, United States
Overview JOB TITLE: Data Integrations Analyst II JOB LOCATION: Reports to office in Reston, VA 20191. REMOTE EMPLOYMENT IS AVAILABLE. TELECOMMUTING FROM ANY LOCATION IN THE UNITED STATES IS POSSIBLE FOR THIS POSITION. REPORTS TO: Lead, Data Integrations Analyst POSITION SUMMARY: The Data Integrations Analyst II plays a key role in the design,
Job Source: HealthEdgeBoston, 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 lives of patients. This responsibility is part of our day-to-day working life by living up to high quality standards and by recognizing the sense of urgency in areas of high unmet medical need.
The Role
The incumbent is responsible for assisting the Validation Manager in completion of all project milestones. This includes writing all validation deliverables within the Computer System Lifecycle, e.g. Validation Plans, Summary Reports, Configuration Specifications. Responsible for developing, revising test validation procedures/protocols, and preparation of all relevant documentation in accordance with appropriate regulatory agency validation requirements, uniQure quality management system and current industry practices.(includes standard operating procedures, technical reports and risk assessments).
Key Responsibilities:
The candidate's responsibilities will include, but are not limited to:
Develop moderately complex test protocols, provides on-site execution support, data analysis, and report generation for various installation, operational and performance qualification activities.
Ensure performance of all qualification activities is in accordance with internal procedures, cGMP industry and regulatory guidance.
Investigates / troubleshoots validation problems.
Support and/or initiate investigations into protocol non-conformances and site deviations.
Serve as initiator and owner of validation related change controls and corrective and preventative actions.
Provides input to standard operating procedures related to validation practices.
Support the implementation of validation programs (e.g., CSA/CSV, Data Integrity).
Represent the validation department at team meetings or projects.
Performs periodic reviews and ongoing support of validated systems post Go-Live.
Perform revalidation and change control validation related activities.
Ability to apply complex system validation principles to work assignments.
Responsible for executing and reviewing control systems validation activities including projects associated with PCS, BMS, CMS, and other automation upgrades.
Assess the impact of system changes thru change management and change control systems; participate in the planning and implementation of change.
Assist validation activities of cross functional teams that include technical functions in all GxP areas such as Quality Control, Information Systems, Manufacturing and QA Engineering.
Qualifications
Individuals proposed for this work must have the following attributes: A minimum of a Bachelor's degree in Engineering in related field with 3 to 5 years of computer system validation experience or Master's Degree in related field with 2 to 4 years of computer system validation experience.
Strong communication skills (written and verbal)
Strong working knowledge on Microsoft Office suite
Ability to work well with diverse groups in a matrix-style, growing, safety focused organization
Ability to manage multiple activities
Attend meetings where required and provide subject matter expertise as applicable on the specifics of the deliverables.
Core competencies The individual must possess strong written and oral communication skills: The ability to communicate with employees of all experience levels from uniQure and other contract firms.
The ability to report on project activity in a clear and concise manner.
The ability to negotiate when necessary and compromise with other project team representatives to achieve project goals.
The ability to listen and respect fellow project team member's ideas and opinions and work through conflict and disagreements.
GMP compliance knowledge including knowledge of 21 CFR Part 11, 210, 211, and 820 requirements, Annex 11, Data Integrity Guidance, ICH Q7A requirements, and GAMP 5.
Experience in thorough testing of applications, computerized systems, changes and implementations.
Excellent written and oral communication to include accurate and legible documentation skills.
Ability to work in a fast-paced environment.
Independent work skills and a strong work ethic.
Must be able to sit or stand for prolonged periods of time.
Must be able to travel between local uniQure facilities.
Good knowledge and skills in Automation systems and process (critical monitoring system)
#J-18808-Ljbffr
Email Alert for CSV Engineer I / II 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.