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Mentor 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 GroupTrinity 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 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: uniQureQ1 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.Q1 Technologies Inc.
Boston, MA, United States
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 experience in quality validation planning and execution Thanks and regards Anil kumar E
Job Source: Q1 Technologies Inc.Beacon 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 HillPlanet Technology
Boston, MA, United States
Contract Duration: 3-6 month project Hours : 9-5pm EST Interview Process: 1 video interview Location: REMOTE, but may need to be onsite in Somerville office on occasion. Position: GXP Documentation Specialist Day to day: * Create GxP documentation * Create validation templates * Perform validation tasks and report the status * Support in updati
Job Source: Planet TechnologyBoston, 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. With offices in Caguas, PR, Boston, MA & San Francisco, CA and we serve life sciences clients in six global markets: United States, Puerto Rico, Dominican Republic, Mexico, Germany, Canada, and South America.
Job Description:
This role pertains to our Talent Bank.
Responsible for the development and execution of Computer System Validation (CSV) and Decommissioning deliverables for Laboratory Equipment/Systems.
Acts as the on-site project leader to plan, execute, and complete control systems projects with assigned client sponsor.
Performs or delegates tasks as required to execute and fully complete assigned projects.
Coordinates communication with the client sponsor during all phases of the project.
Provides work direction to team members, and administration, as necessary.
Ensures work performed is in compliance with company policy and procedures, and regulations.
Lab Equipment/systems may include GMP equipment’s such as: (KFT (Coulometric), FT-NIR, LIF, NIR, Homogenizer, Spectrophotometer, DQAS, Accelerated Surface Area and Porosimetry System, KFT (Volumetric), FTIR, Titrator (Potentiometric), TPW, Freezers, Refrigerators).
Requirements/Qualifications:
Bachelor’ s degree or higher in Chemistry/Biology/Microbiology/Computer Science/Information Systems/Engineering or related discipline.
Minimum of eight (8) years of experience validating laboratory computerized systems in a manufacturing environment is required.
Knowledge of SDLC regulations, including 21CFR part 11, computer systems validation requirements.
Must have experience in configuring computerized systems with complex vendor software systems, and windows operating systems.
Must have experience drafting and executing test plans intended to show system compliance with part 11, including items like, user access levels, audit trails, backup, restore, etc.
Knowledge of cGMP, GXP, GAMP, and good documentation practices.
Advanced knowledge of pharmaceutical, manufacturing and laboratory systems.
Understanding of investigations, deviations and CAPA management in a regulated pharmaceutical industry.
Strong written and verbal communication skills.
Excellent interpersonal skills with experience dealing with a diverse workforce.
Strong multi‐tasking ability in conjunction with proven organizational skills. Ability to organize assigned tasks in a high paced environment and concurrently monitor tasks / assignments with others that may impact timely completion. Ability to effectively manage multiple tasks and activities simultaneously.
Highly proficient computer skills in Microsoft Office Suite – Word, Excel, PowerPoint and Outlook with extensive background in database systems. Innate ability to learn new software, such as corporate intranet and enterprise business.
Experience authoring, owning and executing qualification documentation.
Mentor Technical Group es un empleador que ofrece igualdad de oportunidades y todos los solicitantes calificados recibirán consideración para el empleo sin importar raza, color, religión, sexo, orientación sexual, identidad de género, información genética, origen nacional, estado de veterano protegido, estado de discapacidad o cualquier otro grupo protegido por ley.
Mentor Technical Group is an equal opportunity employer, and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, genetic information, national origin, protected veteran status, disability status, or any other characteristic protected by law.
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Email Alert for CSV Specialist jobs in Boston, MA, United States
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