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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 ConsultantsJobot
Boston, MA, United States
Expert Program Management level within Computer System Validation of GXP/CXR Lab settings. Long term consulting role looking for immediate impact! This Jobot Consulting Job is hosted by: Brett Walker Are you a fit? Easy Apply now by clicking the "Apply" buttonand sending us your resume. Salary: $100 - $125 per hour A bit about us: A leading Lab
Job Source: JobotKatalyst HealthCares & Life Sciences
Bridgewater, MA, United States
Responsibilities: 7+ years of experience in Computer System Validation Reviewing and approving validation deliverables of GxP regulated Computerized Systems to ensure full compliance with Health Authority regulatory requirements and adherence to company policies and procedures by supporting computer validation projects and base business support t
Job Source: Katalyst HealthCares & Life SciencesVeeva
Boston, MA, United States
Veeva Systems is a mission-driven organization and pioneer in industry cloud, helping life sciences companies bring therapies to patients faster. As one of the fastest-growing SaaS companies in history, we surpassed $2B in revenue in our last fiscal year with extensive growth potential ahead. At the heart of Veeva are our values: Do the Right Thing
Job Source: VeevaSaxon Global
Boston, MA, United States
Company: Apellis Pharmaceutical Title: IT Business Systems Analyst Location: 100 5 th Ave, Waltham, MA 02451 - 100% remote Duration: 6 Months w/possible extensions Visa: No H1 Rate:$65/hr. on C2C Senior Role - must have 10+ years of experience - Very strong with Veeva Vault Applications Candidates MUST Have: Recent strong Veeva Vault Experie
Job Source: Saxon 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 GroupDPS 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 GlobalProject Farma
Boston, MA, United States
This role can involve up to 100% Travel Why Precision for Medicine? Welcome to the forefront of innovation in cutting edge patient treatments. We are thrilled to present an incredible opportunity to join our high performing organization. As a leader within the life science industry, we are constantly pushing the boundaries of what is possible and
Job Source: Project FarmaCanton, 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 within regulated environments.
Key Responsibilities:
Software Validation: Execute validation activities for laboratory and analytical software systems, ensuring compliance with regulatory requirements such as FDA, EU GMP, and other relevant standards.
Documentation: Develop and maintain validation documentation including validation plans, protocols, test scripts, and summary reports in alignment with company SOPs and regulatory guidelines.
Risk Management: Conduct risk assessments to identify and mitigate potential software validation risks, ensuring the integrity of data generated by lab and analytical equipment.
Change Control: Manage change control processes related to software validation activities, ensuring that changes are implemented in a controlled and documented manner.
Cross-functional Collaboration: Collaborate closely with cross-functional teams including Quality Assurance, IT, Engineering, and Operations to ensure alignment of validation activities with overall business objectives.
Controlled Temperature Units: Specifically focus on the validation of software systems associated with controlled temperature units, ensuring accuracy and reliability of temperature monitoring and control.
Qualifications:
Minimum of 5+ years of experience in computer software validation within regulated industries, with a focus on lab and analytical equipment and software.
In-depth knowledge of regulatory requirements such as FDA 21 CFR Part 11, EU GMP Annex 11, and GAMP 5.
Experience with validation tools and methodologies, including IQ/OQ/PQ, CSV risk assessments, and traceability matrices.
Strong understanding of controlled temperature units and their integration with software systems.
Excellent communication and interpersonal skills, with the ability to collaborate effectively with cross-functional teams.
P1378684BOSJB_1717766746
To Apply for this Job Click Here
Email Alert for Computer Software Validation (CSV) Consultant jobs in Canton, MA, United States
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