Current jobs related to Senior Computerized Systems Validation Engineer - College Station, Texas - FUJIFILM Corporation
-
College Station, Texas, United States CPMNA Full timeJob OverviewSalary: The Senior Engineer for Computer System Validation (CSV) will operate under general supervision, taking charge of all GxP-Regulated Computerized Systems throughout the entire lifecycle of these systems. This role is crucial in ensuring adherence to regulatory standards, CSV protocols, and Data Integrity requirements.Key Responsibilities:...
-
Senior Computer System Validation Engineer
4 weeks ago
College Station, Texas, United States BioPharma Consulting JAD Group Full timeJob OverviewSummary: BioPharma Consulting JAD Group is in search of a skilled and knowledgeable Senior Engineer specializing in Computer System Validation (CSV). This role is pivotal in ensuring adherence to regulatory standards and industry benchmarks for computerized systems utilized in pharmaceutical production.Key Responsibilities:Develop, secure...
-
Senior Engineer
4 weeks ago
College Station, Texas, United States CPMNA Full timeJob OverviewAs a Senior Engineer in Computer System Validation at CPMNA, you will play a pivotal role in overseeing GxP-Regulated Computerized Systems throughout their lifecycle. Your primary focus will be ensuring adherence to regulatory standards, CSV protocols, and Data Integrity requirements.Key Responsibilities:Develop, obtain approvals for, and execute...
-
Computer System Validation Specialist
4 weeks ago
College Station, Texas, United States Ellab - Validation & Monitoring Solutions Full timeExciting Career Opportunity at Ellab - Validation & Monitoring SolutionsWe are looking for a Computer System Validation/Data Integrity Specialist to become a vital part of our dynamic organization and engage in a rewarding professional journey.As a leader in our industry, Ellab is dedicated to offering exceptional benefits that distinguish us from the...
-
Senior Validation Engineer
3 weeks ago
College Station, Texas, United States Valspec Full timeJob OverviewValspec, a prominent provider of system validation and lifecycle services, specializes in the commissioning and qualification of computerized systems within the Life Sciences sector. Since its inception in 1999, Valspec has dedicated itself to delivering a comprehensive range of services that assist clients in achieving their capital project and...
-
Senior Validation Engineer
4 weeks ago
College Station, Texas, United States Valspec Full timeJob OverviewValspec, a renowned provider of system validation and lifecycle services, specializes in the commissioning and qualification of computerized systems for clients within the Life Sciences sector. Since its inception in 1999, Valspec has dedicated itself to delivering a comprehensive range of services that assist clients in achieving their capital...
-
Senior Validation Engineer
3 weeks ago
College Station, Texas, United States Valspec Full timeJob OverviewValspec, a prominent global provider of system validation and lifecycle services, specializes in the commissioning and qualification of computerized systems for clients within the Life Sciences sector. Since its inception in 1999, Valspec has been dedicated to delivering a comprehensive range of services that assist clients in achieving their...
-
Senior Validation Engineer
2 weeks ago
College Station, Texas, United States Valspec Full timeJob SummaryWe are seeking a highly skilled Senior Validation Engineer to join our team at Valspec. As a key member of our validation team, you will be responsible for ensuring the quality and integrity of our clients' facilities, utilities, systems, and equipment.Key ResponsibilitiesValidation Project Planning: Develop and execute validation project plans,...
-
Validation Specialist
3 weeks ago
College Station, Texas, United States Metric Bio Full timeAbout the RoleMetric Bio is seeking a highly skilled Validation Specialist to join our team. As a key member of our organization, you will play a critical role in ensuring the quality and integrity of our computerized systems and processes.Key ResponsibilitiesValidation Management: Lead the development, approval, and execution of validation deliverables for...
-
Lead Computer Systems Validation Specialist
4 weeks ago
College Station, Texas, United States FUJIFILM Corporation Full timePosition OverviewAt FUJIFILM Corporation, we recognize the significance of our work in the biopharmaceutical sector, and we are eager to welcome skilled professionals to our team. We are expanding our operations and capabilities, seeking dedicated individuals who are passionate about making a meaningful impact in healthcare. Join us in our mission to develop...
-
Validation Specialist
10 hours ago
College Station, Texas, United States Ellab - Validation & Monitoring Solutions Full time{"title": "Validation Engineer", "description": "Exciting Opportunity at EllabWe're seeking a skilled Validation Engineer to join our team and contribute to our mission of providing cutting-edge solutions.Key Responsibilities:Generate, obtain approvals, and execute validation deliverables for facilities, utilities, systems, and equipment.Validate various...
-
CSV Senior Engineer
3 weeks ago
College Station, Texas, United States CPMNA Full timeJob OverviewAs a Senior Engineer in Computer System Validation at CPMNA, you will play a crucial role in ensuring that all GxP-Regulated Computerized Systems are compliant throughout their lifecycle. Your expertise will guide the validation processes, aligning with regulatory standards and Data Integrity requirements.Key Responsibilities:Oversee the...
-
Validation Manager
5 days ago
College Station, Texas, United States FUJIFILM Corporation Full timeJob Title: Manager, CSVOverview:The Manager, CSV will be responsible for ensuring the compliance of all GxP-Regulated Computerized Systems at our manufacturing facilities. This includes management, scheduling, and oversight of all validation activities, ensuring adherence to regulatory requirements, Computer Systems Validation (CSV) and Lifecycle procedures...
-
Validation and Qualification Engineer
4 weeks ago
College Station, Texas, United States CPMNA Full timeJob OverviewThe Validation Engineer at CPMNA will play a crucial role in the development and execution of validation protocols for Facilities, Utilities, Systems, and Equipment (FUSE). This position involves preparing comprehensive validation reports and ensuring compliance with regulatory standards.Key Responsibilities:Develop, obtain necessary approvals,...
-
Quality Assurance Validation Engineer
4 weeks ago
College Station, Texas, United States Valspec Full timeJob OverviewValspec, a prominent global provider of system validation and lifecycle services, is dedicated to delivering commissioning and qualification of computerized systems for clients within the Life Sciences sector. Our mission, established in 1999, is to offer a comprehensive range of services that assist our clients in achieving their capital project...
-
Validation Manager
6 days ago
College Station, Texas, United States FUJIFILM Corporation Full timeJob Title: Manager, CSVOverview:The work we do at FUJIFILM Corporation has never been more important, and we are looking for talented candidates to join our team. We are growing our locations, our capabilities, and our teams, and looking for passionate, mission-driven individuals who want to make a real difference in people's lives. Our company is advancing...
-
Senior Systems Research and Development Engineer
2 weeks ago
College Station, Texas, United States Applied Research Laboratory at the Penn State University Full time{"h2": "Senior Systems Research and Development Engineer Position", "p": "The Applied Research Laboratory at Penn State University is seeking a highly skilled and experienced Senior Systems Research and Development Engineer to join our team. As a key member of our Communications and Signal Processing Division, you will be responsible for leading research and...
-
Validation Engineer
4 weeks ago
College Station, Texas, United States Salent Solutions Full timeJob OverviewPosition: Validation EngineerCompany: Salent SolutionsCompensation: Commensurate with ExperienceAbout the Role:Salent Solutions specializes in providing commissioning, qualification, and validation services tailored for the biotech and pharmaceutical sectors. Our commitment lies in delivering exceptional service to organizations that manufacture...
-
Automation Validation Engineer
4 weeks ago
College Station, Texas, United States Salent Solutions Full timeJob OverviewPosition: Automation Validation EngineerCompany: Salent SolutionsCompensation: Competitive based on experienceAbout the Role:Salent Solutions is dedicated to delivering exceptional commissioning, qualification, and validation services tailored for the biotech and pharmaceutical sectors. Our commitment to quality service supports organizations...
-
Automation Validation Engineer
4 weeks ago
College Station, Texas, United States Salent Solutions Full timeCSV Engineer - Automation Company: Salent Solutions Compensation: Commensurate with Experience About this opportunity: Salent Solutions is dedicated to providing commissioning, qualification, and validation services tailored for the biotech and pharmaceutical sectors. Our commitment lies in delivering exceptional service to organizations that develop...
Senior Computerized Systems Validation Engineer
3 months ago
Overview:
The work we do at FDB has never been more importantand we are looking for talented candidates to join us. We are growing our locations, our capabilities, and our teams, and looking for passionate, mission-driven people like you who want to make a real difference in peoples lives. Join FDB and help create the next vaccine, cure, or gene therapy in partnership with some of the most innovative biopharma companies across the globe. We are proud to cultivate a culture that will fuel your passion, energy and drive - what FDB call Genki.
External US:College Station, Texas may be a small, university town, but the lively cultural scene and local amenities make it a great place for families as well as those who want the ease of small-town life and the convenience of living close to the vibrant pulse of big cities. Eighty-seven percent of Texas' population lives within a 180-mile radius, so we are in the center of it all in Texas. And our site is nestled in the hub of innovation, representing a source of pride for the area.
The Senior Computerized Systems Validation Engineer, under general direction, will be responsible for oversight of all GxP-Regulated Computerized Systems at all applicable points of the computerized system lifecycle, ensuring compliance with regulatory requirements, Computer Systems Validation (CSV) and Lifecycle procedures with Data Integrity requirements. This individual will provide oversight of validation activities, lead the development and approval of validation documentation, risk assessments, work with project teams to determine which elements should be validated, and conduct impact assessments of proposed changes to computerized systems.
Reports to Associate Director, Validation
Work Location College Station, TX
Primary Responsibilities:
- Generate, obtain approvals, and execute validation deliverables for computerized systems and relevant infrastructure, including Validation Plans, Requirements Specification, Risk Assessments, Installation/Operational Qualifications, Traceability Matrices, and Validation Final Reports, ensuring documents meet regulatory and procedural requirements of 21 CFR Part-11, Annex-11 Data Integrity and GAMP5 among others.
- Plan and organize validation activities amongst cross functional groups; capable of providing and maintaining status updates for validation activities related to day-to-day operations or project work
- Must be able to review all System Delivery Life Cycle (SDLC) deliverables, provide constructive feedback, and ensure that the deliverables adhere to associated Standard Operating Procedures (SOPs).
- Must be able to create, review, and update SOPs, forms, templates, documentation, and files.
- Supports regulatory and client audits as CSV subject matter expert.
- Perform other duties as assigned.
Qualifications:
- Master of Science Degree in Computer Science, Life Sciences, Engineering, or similar discipline with 3+ years of experience in computer system validation activities in pharmaceutical, biotechnology, or related industry, preferably in FDA-regulated environments, OR;
- Bachelor of Science Degree in Computer Science, Life Sciences, Engineering, or similar discipline with 5+ years of experience in computer system validation activities in pharmaceutical, biotechnology, or related industry, preferably in FDA-regulated environments, OR;
- Associate of Science Degree in Computer Science, Life Sciences, Engineering, or similar discipline with 7+ years of experience in computer system validation activities in pharmaceutical, biotechnology, or related industry, preferably in FDA-regulated environments.
- Knowledge of DeltaV automation platform preferred.
- Working knowledge of engineering principles.
- Working knowledge and expertise in computerized systems validation.
- Computer System Validation experience with DCS, SCADA and BMS systems such as DeltaV, Factory Talk View, Desigo, Unicorn, Wonderware is preferred.
- Thorough knowledge of 21 CFR Part 11, Annex 11, Data Integrity, GAMP5 requirements and FDA industry regulations.
- Excellent written and oral communication skills.
- Working knowledge and experience in Microsoft Office products (Outlook, Word, Excel, Power Point).
- Ability to work with minimal supervision.
- Desire to work in fast-paced, state of the art, alternately research and customized manufacturing facility.
- Role model for company core values of trust, delighting our customers, Gemba, and Genki.
Physical Requirements:
The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. While performing the duties of this job, the employee is regularly required to:
- Experience prolonged standing, some bending, stooping, and stretching.
- Use hand-eye coordination and manual dexterity sufficient to operate a keyboard, photocopier, telephone, calculator, and other office equipment is required.
- The ability to regularly lift and/or move up to 10 pounds and occasionally lift and/or move up to 50 pounds.
- Working on ladders.
- Attendance is mandatory.
Join us FDB is advancing tomorrows medicine, impassioning employees to chase the impossible and continually expand their potential. We are a company of emboldened goal seekers driven by an innate desire to better ourselves, our families, our workplace, our company, our community and the world at large.
We are an equal opportunity and affirmative action employer.? All qualified applicants will receive consideration without regard to race, color, national origin, sex, gender identity, sexual orientation, religion, disability, protected veteran status or any other characteristic protected by applicable federal, state or local law. If an accommodation to the application process is needed, please email or call
To all agencies: Please, no phone calls or emails to any employee of FUJIFILM about this requisition. All resumes submitted by search firms/employment agencies to any employee at FUJIFILM via-email, the internet or in any form and/or method will be deemed the sole property of FUJIFILM, unless such search firms/employment agencies were engaged by FUJIFILM for this requisition and a valid agreement with FUJIFILM is in place. In the event a candidate who was submitted outside of the FUJIFILM agency engagement process is hired, no fee or payment of any kind will be paid.
