Orano Med, a subsidiary of the Orano Group, is a fast-growing clinical stage biotech company focusing on the development of targeted alpha therapy (TAT), an innovative class of pharmaceutical agents to combat cancer. Based on strong preclinical and clinical results, Orano Med is preparing for the commercialization of its products. Orano Med is looking for passionate employees willing to take responsibility and grow with the company.

Job Description:

Orano Med is seeking a Computer Systems Validation Specialist to support implementing and managing electronic systems in a GMP environment ensuring compliance with FDA 21 CFR part 11/ Eudralex Electronic Records/Electronic Signatures regulation and 21 CFR/Annex 11 EU-GMP by identifying, validating and auditing electronic systems.

Major Duties and Responsibilities:

Ensure regulatory compliance of electronic systems by:

• Developing CFR Part 11 computer systems validation plans, qualifications test protocols, traceability matrices, reports, IQ/OQ protocols and all documents, and deliverables within the scope of the validation plan
• Developing and maintaining test plans, test scripts and user acceptance tests and manage the execution of test plans
• Develop and maintain procedures related to Data Integrity and software validation, and lead 21 CFR Part 11 related training to all departments
• Identifying and qualifying all computer systems which impact cGMP operations using a risk-based methodology
• Working closely with Quality Assurance, Facilities and Engineering Teams to ensure appropriate validation of cGMP computer systems
• Lead the electronic systems implementation teams in the proper execution of validation documents
• Perform project management activities for CSV processes within the scope of an overall system project
• Execute or oversee the execution of validation plans and validation documents
• Act as the CSV Lead for all computer system validation projects, including spreadsheet and quality system validations
• Work with overall project manager to include validation activities in implementation timelines
• Evaluate proposed changes to validated computer systems and recommend level of revalidation activities required
• Review standards/regulation updates and perform gap assessments
• Coordinate and perform audits of internal computer systems, validation activities, protocols, and procedures, and prepare responses
• Lead corrective actions/preventative actions (CAPAs) pertaining to CSV
• Ensure initiation/preparation and closeout of all CSV related deviations, discrepancies, and change control documents
• Maintain cGMP compliance and serve as the subject matter expert during regulatory audits
• Other duties as assigned (such as provide expertise on design of IS systems and drafting of USR)
• Remote position based in Brownsburg, IN, & initially 20% travel to Plano, TX