Validation Expert

As a qualified candidate passionate about delivering computer system validation and risk management approaches to support tremendous IT and business growth, you will join the IT team as part of the ITRMC (IT Risk Management & Compliance). In this role, you will interface between the quality business unit, IT, business customers, and vendors on various computer system validation projects and compliance initiatives. Over the next 3 years, the business plans to deploy major operational systems like LIMS, ERP, MES, VLMS, EBR to enhance capabilities and improve customer service, and you will play a crucial role in achieving these objectives. Your responsibilities will include providing technical and compliance expertise for the strategy and execution of computer systems validation in alignment with regulatory standards such as 21 CFR Part 11, 211, 820, GAMP, CSA. You will conduct IT change control impact assessments, develop project documentation, and lead compliance improvement initiatives. Additionally, you will run computer system validation efforts, provide coaching to stakeholders on best practices, advise on IT project execution from a risk and compliance standpoint, and offer IT audit support for internal and external audits. You will stay updated on computer systems validation approaches, industry trends, and health agency guidance, and support software supplier assessments for IT systems within the manufacturing and quality plane. In addition, you will oversee junior roles, staff augmentation, or vendor services for larger projects, ensuring IT life cycle compliance operations are carried out efficiently. The ideal candidate will have a Bachelor's degree in Computer Science, IT, or a related discipline, with 8+ years of experience in pharma/device or other regulated industries. Proficiency in English and citizenship in the U.S. or UK are required. Deep knowledge of lab systems, manufacturing systems, quality systems, and regulatory compliance processes is essential, along with experience in SDLC/GAMP and IT project management methodologies. Additional qualifications such as Lean Six Sigma, ASQ certification, and training in FDA CSA are advantageous.,