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.
Minimum Qualifications:
- Bachelor’s degree in Computer Science or science field and a minimum 2-5 years of experience with GMP document creation related to CSV.
- Knowledge of cGMP, GDP, GAMP, 21CFR 210, 211, 58, and Part 11.
- Understanding of principles of data integrity and the relationship to regulatory requirements. (e. g., 21CFR Part 11).
- Must be results driven, a self-starter, and possess strong interpersonal and communication skills in addition to strong verbal and technical writing skills.
- Knowledge of Electronic document management systems (EDMS) like Kneat or any other similar EDMS systems.
- Must be able to multi task and adjust rapidly to new priorities.
- Knowledge and experience with system/database design and architecture, change control, as well as System Development Life Cycle (SDLC) and Quality Assurance (QA) methodologies is required.
- 3 years of experience in GAMP5 model used to support cGMP validated software systems.
- Authorization to work in the United States indefinitely without restriction or sponsorship.
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.
The position is full-time, Monday-Friday, 8am-4:30pm, with overtime as needed. Candidates who live within a commutable distance from 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.
Eurofins is a M/F, Disabled, and Veteran Equal Employment Opportunity and Affirmative Action employer.
