Quality Engineering Validation Specialist - Eurofins BioPharma Product Testing Columbia, LLC

Company Description

Eurofins is the world leader in the bio/pharmaceutical testing market. With over €5.3billion in annual revenues and 55,000 employees across 900 sites in50 countries, Eurofins is a leading international group of laboratories providing an unparalleled range of testing and support services to the pharmaceutical, biopharmaceutical, food, environmental, and consumer products industries and to governments.

The Eurofins BioPharma Product Testing (BPT) Group is the largest network of harmonized bio/pharmaceutical GMP product testing laboratories worldwide. Eurofins BPT provides comprehensive CMC laboratory services for the world's largest pharmaceutical and biopharmaceutical companies. The service portfolio supports all stages of the drug development process and all functional areas of bio/pharmaceutical manufacturing, including method development, microbiology, process validation and quality control.

Job Description

Eurofins BPT-Columbiais looking for aQuality Engineering Validation Specialistto join our Quality Systems team located in Columbia, Missouri. The Validation Specialist Iwill 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.

Qualifications

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.