Engineering Validation Specialist
1 month ago
Job Description
Eurofins BPT-Columbia is looking for a Quality Engineering **Validation Specialist ****** to join our Quality Systems team located in Columbia, Missouri. The Validation Specialist I will have responsibility for computer system validation activities. This will include working closely with the Part 11 Team, QA, the validation teams, and Quality Engineering to assure compliance with US FDA regulations, as well as Eurofins BioPharma Product Testing Columbia, and Eurofins corporate policies and procedures.
To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
Essential Duties and Responsibilities include:
Responsible for providing guidance and writing, reviewing / approving CSV lifecycle documents such as Validation Plans, GxP Assessments, Traceability Matrices, Risk Management Plans and Validation Summary Reports. Authoring and execution of validation protocols, specifications, change controls and/or scripts related to assigned software, instruments and/or equipment according to the organization's compliance requirements and industry regulations. Maintain awareness of data management, validation, and data integrity needs in a GxP regulated environment. Must rapidly become current and remain expert on the regulatory requirements pertaining to computer systems used in the manufacture and testing of pharmaceutical products. Maintain validation documentation to ensure timely retrieval in support of client and regulatory audits. Assist in preparation and maintenance of Quality System support documentation, including, but not limited to, computer system validation SOPs. Draft templates for High level Risk Assessments, User Requirements Specification, Validation Plan and Validation Summary Reports. Prepare Validation Plans, IQ, OQ, Validation Summary Reports. Maintain close communication with key stakeholders and system owners to keep apprised of computer system’s needs, impacts on validation, project validation status and other relevant issues pertaining to validation. Completes periodic reviews on computerized systems per established procedure. Performs other related duties as required and directed.The ideal candidate would possess :
Strong computer, scientific, and organizational skills. Excellent communication (oral and written) and attention to detail. Ability to read, analyze, and interpret the most complex documents. Ability to respond effectively to the most sensitive inquiries or complaints. Ability to write speeches and articles using original or innovative techniques or style. Ability to make effective and persuasive speeches and presentations on controversial or complex topics to top management, public groups, and/or boards of directors. Ability to apply principles of logical or scientific thinking to a wide range of intellectual and practical problems. Ability to deal with nonverbal symbolism (formulas, scientific equations, graphs, musical notes, etc.,) in its most difficult phases. Ability to deal with a variety of abstract and concrete variables. Ability to apply critical thinking when developing validation documentation, working with laboratory systems and managing all aspect of the position. Ability to learn new techniques, perform multiple tasks simultaneously, keep accurate records, follow instructions, and comply with company policies. To perform this job successfully, an individual will need to gain knowledge of a variety of laboratory software systems, spreadsheet software, and word Processing software. Ability to work independently and as part of a team, self-motivation, adaptability, and a positive attitude.Qualifications:
Qualifications
Additional Information
Position is full-time, Monday-Friday, 8 a.m.-4:30 p.m., with overtime as needed. Candidates currently living within a commutable distance of Columbia, MO are encouraged to apply.
As a Eurofins employee, you will become part of a company that has received national recognition as a great place to work. We offer excellent full-time benefits including comprehensive medical coverage, life and disability insurance, 401(k) with company match, paid holidays and PTO, and dental and vision options.
To learn more about Eurofins, please explore our website www.eurofinsus.com .
We are looking forward to receiving your application including your expected salary and possible start date via our career website.
**\ #LI-EB1 **
Eurofins is a M/F, Disabled, and Veteran Equal Employment Opportunity and Affirmative Action employer.
-
Bioprocessing Validation Specialist
3 weeks ago
Columbia, South Carolina, United States Trinity Consultants - Advent Engineering Full timeJob SummaryWe are seeking a highly skilled Bioprocessing Validation Specialist to join our team at Trinity Consultants - Advent Engineering. As a key member of our engineering and consulting firm, you will be responsible for ensuring the quality and compliance of our clients' biotechnology and pharmaceutical manufacturing processes.Key...
-
Biotech Validation Specialist
3 weeks ago
Columbia, South Carolina, United States Trinity Consultants - Advent Engineering Full timeValidation EngineerAt Trinity Consultants - Advent Engineering, we are seeking a skilled Validation Engineer to join our team. As a key member of our engineering and consulting firm, you will be responsible for ensuring the quality and compliance of our clients' biotechnology and pharmaceutical manufacturing processes.Key Responsibilities:Qualify and...
-
Quality Engineering Validation Specialist
2 months ago
Columbia, United States Eurofins USA BioPharma Services Full timeJob DescriptionJob DescriptionCompany DescriptionEurofins Scientific is an international life sciences company, providing a unique range of analytical testing services to clients across multiple industries, to make life and our environment safer, healthier and more sustainable. From the food you eat, to the water you drink, to the medicines you rely on,...
-
Validation Specialist
2 weeks ago
Columbia, South Carolina, United States Hughes Consulting, A Salas O'Brien Company Full timeJob Title: Validation EngineerHughes Consulting, A Salas O'Brien Company is a dynamic and fast-growing organization focused on delivering exceptional engineering services and project management solutions to the pharmaceutical industry.We are seeking a highly skilled Validation Engineer to join our team and contribute to the completion of validation projects....
-
Validation Specialist
1 week ago
Columbia, Missouri, United States Eurofins USA BioPharma Services Full timeJob DescriptionEurofins USA BioPharma Services is seeking a highly skilled Validation Specialist to join our Quality Systems team in Columbia, Missouri. The successful candidate will be responsible for ensuring the compliance of computer systems with US FDA regulations and Eurofins corporate policies and procedures.Key Responsibilities:Develop and implement...
-
CTU Validation Specialist
3 weeks ago
Columbia, South Carolina, United States Technical Source Full timeCTU Validation Engineer OpportunityTechnical Source is seeking a skilled CTU Validation Engineer to join our team in the Raleigh-Durham-Chapel Hill area. This is a long-term contract position requiring on-site work.Key Responsibilities:Validate controlled temperature units to ensure compliance with regulatory standardsDevelop and execute commissioning...
-
Verification and Validation Specialist
3 weeks ago
Columbia, South Carolina, United States Platform Recruitment Full time{"h1": "Verification and Validation Engineer", "p": "At Platform Recruitment, we are seeking a skilled Verification and Validation Engineer to join our client's MedTech team. This exciting opportunity involves ensuring the functionality, performance, and regulatory compliance of a flagship product. You will work closely with design, firmware, and quality...
-
CQV Validation Specialist
5 days ago
Columbia, South Carolina, United States Novozen Healthcare LLC Full timeCQV Engineer Job DescriptionWe are seeking a highly skilled CQV Engineer to join our team at Novozen Healthcare LLC in ensuring the commissioning, qualification, and validation of pharmaceutical/biotech equipment, utilities, and facilities in compliance with Good Manufacturing Practices (GMP).Key Responsibilities:Lead and perform commissioning,...
-
Process Validation Specialist
3 weeks ago
Columbia, South Carolina, United States Technical Source Full timeProcess Validation Engineer OpportunityTechnical Source is seeking a skilled Process Validation Engineer to join our team in the Rocky Mount-Wilson, NC area. This long-term contract opportunity requires on-site work and involves process validation duties, sampling, and technical transfers.Key Responsibilities:Develop and execute process validation protocols...
-
Process Validation Specialist
3 weeks ago
Columbia, South Carolina, United States Technical Source Full timeProcess Validation Engineer OpportunityTechnical Source is seeking a skilled Process Validation Engineer to join our team in the Rocky Mount-Wilson, NC area. This long-term contract opportunity requires on-site work and involves process validation duties, sampling, and technical transfers.Key Responsibilities:Develop and execute process validation protocols...
-
Senior Validation Specialist
2 weeks ago
Columbia, South Carolina, United States Avance Consulting Full timeJob OverviewAvance Consulting is seeking a highly skilled Validation Engineer to support the performance of FAT, SAT, CSV, and CQV, as well as the development of applicable protocols and summary reports.Key ResponsibilitiesProvide support in the performance of FAT, SAT, CSV, and CQVDevelop applicable protocols and summary reportsWork in a pharmaceutical CGMP...
-
Process Validation Specialist
4 weeks ago
Columbia, South Carolina, United States Technical Source Full time**Technical Source** is currently seeking a skilled **Process Validation Engineer** to support our pharmaceutical manufacturing client in the production of high-quality products. This is a long-term contract opportunity that operates on a second shift schedule.**Key Responsibilities:**Develop and execute process validation protocols to ensure compliance with...
-
Senior Commissioning and Validation Engineer
3 weeks ago
Columbia, South Carolina, United States Quanta part of QCS Staffing Full timeJob DescriptionQuanta, part of QCS Staffing, is seeking a highly skilled and independent Commissioning, Qualification, and Validation (CQV) Engineer to join our team for a large greenfield project at our Contract Development and Manufacturing Organization (CDMO) facility.Key Responsibilities:Review and Validate Turnover Packages: Ensure that all turnover...
-
Construction Engineer and Inspection Specialist
1 month ago
West Columbia, South Carolina, United States INFRASTRUCTURE CONSULTING & ENGINEERING Full timeAbout the RoleWe are seeking a highly motivated and detail-oriented individual to join our team as a Construction Engineer and Inspection Specialist. This is an exciting opportunity to apply your academic knowledge to real-world scenarios and develop practical skills in the field of construction engineering and inspection.Key ResponsibilitiesAssist with site...
-
Senior Electrical Engineer
4 weeks ago
Columbia, Maryland, United States TAP Engineering Full timeJob SummaryTAP Engineering is seeking a highly skilled Senior Electrical Engineer to lead and support our Integrated Product Teams in the design, analysis, manufacture, and test of digital and RF/analog and mixed electronics hardware at all levels of integration.Key ResponsibilitiesParticipate in multi-disciplinary teams to architect technical...
-
Columbia, South Carolina, United States CLA (CliftonLarsonAllen) Full timeJob Title: Process Engineer: Isolator Technical SpecialistCompany Overview:CliftonLarsonAllen (CLA) Search has been retained by Optima Machinery Corporation to identify a Process Engineer: Isolator Technical Specialist to join their team. With a global presence, Optima Machinery Corporation designs and builds packaging and filling machines for various...
-
Columbia, South Carolina, United States CLA (CliftonLarsonAllen) Full timeJob Title: Process Engineer: Isolator Technical SpecialistCompany Overview:CliftonLarsonAllen (CLA) Search has been retained by Optima Machinery Corporation to identify a Process Engineer: Isolator Technical Specialist to join their team. With a global presence, Optima Machinery Corporation designs and manufactures packaging and filling machines for...
-
Water Resources Engineer
2 weeks ago
Columbia, South Carolina, United States INFRASTRUCTURE CONSULTING & ENGINEERING Full timeJob Title: Water Resources EngineerWe are seeking a highly skilled Water Resources Engineer to join our team in West Columbia, SC. As a key member of our infrastructure design team, you will be responsible for providing technical planning, design, and construction support for hydrologic and hydraulic models, erosion control, stormwater abatement, and green...
-
Columbia, South Carolina, United States Praxis Engineering Full timeJob SummaryWe are seeking a highly skilled Cybersecurity Expert to join our team at Praxis Engineering. As an Information Systems Security Engineer, you will be responsible for safeguarding digital landscapes and ensuring compliance with stringent Information Assurance (IA) standards and regulations.Key ResponsibilitiesConduct technical security assessments...
-
Columbia, South Carolina, United States Praxis Engineering Full timeExciting Opportunity for a Cybersecurity ExpertWe are seeking a highly skilled Cybersecurity Expert to join our team at Praxis Engineering. As an Information Systems Security Engineer, you will be responsible for safeguarding digital landscapes and ensuring compliance with stringent Information Assurance (IA) standards and regulations.Your Mission:As a...
