Job Description

Overview:
Emmes Group: Building a better future for us all.
Emmes Group is transforming the future of clinical research, bringing the promise of new medical discovery closer within reach for patients. Emmes Group was founded as Emmes more than 47 years ago, becoming one of the primary clinical research providers to the US government before expanding into public-private partnerships and commercial biopharma. Emmes has built industry leading capabilities in cell and gene therapy, vaccines and infectious diseases, ophthalmology, rare diseases, and neuroscience.
We believe the work we do will have a direct impact on patients' lives and act accordingly. We strive to build a collaborative culture at the intersection of being a performance and people driven company. We're looking for talented professionals eager to help advance clinical research as we work to embed innovation into the fabric of our company. If you share our motivations and passion in research, come join us!
Primary Purpose
Senior Computer Systems Validation (CSV) Specialist is responsible for ensuring that computerized systems used within the organization comply with regulatory requirements (e.g., FDA 21 CFR Part 11, GxP, EMA Annex 11) and internal quality standards. This role involves planning, executing, and maintaining validation activities throughout the system lifecycle, including risk assessments, validation plans, protocols, tests, reports, and change control. The senior specialist will provide leadership, guidance, and oversight to project teams, ensuring that systems are timely validated in alignment with compliance requirements and business objectives. Responsibilities:
Lead, design, and execute CSV protocols for new and existing GxP-regulated systems.
Develop and review validation deliverables, including URS, FRS, IQ, OQ, PQ, test scripts, and validation summary reports.
Ensure compliance with applicable regulatory standards such as FDA, EMA, ICH, and industry best practices.
Conduct risk assessments and apply risk-based approaches to validation activities.
Partner with IT, Quality Assurance, and Business Units to ensure system implementations meet compliance requirements.
Provide oversight for vendor-supplied systems, including review of vendor validation packages.
Support audit readiness by maintaining proper documentation and participating in internal and external inspections.
Mentor and provide technical guidance to CSV junior staff and train other validation team members on its best practices.
Manage validation activities in alignment with project timelines, deliverables, and resource planning.
Participate in change control, deviation management, and CAPA processes related to computerized systems.
Propose and implement process upgrades and efficiency improvements Qualifications:

• Bachelor's degree is required.
• Advanced degree (Master's) preferred but not required.
• Certified CSV training preferred but not required.
• Minimum of 5 years of experience in Computer Systems Validation within a regulated industry (pharmaceutical, biotechnology, medical device, or clinical research).
• Strong background in GxP environments and validation of various types of systems (ERP, LIMS, eQMS, CTMS, clinical trial systems, etc.).
• Demonstrated experience with global regulatory requirements (FDA, EMA, MHRA) and industry standards (GAMP 5).
• Proven track record of leading validation projects and cross-functional teams.
• Experience working with cloud-based and SaaS solutions is highly desirable.
• In-depth understanding of CSV methodologies, GAMP 5, and risk-based validation approaches.
• Strong knowledge of FDA 21 CFR Part 11, EMA Annex 11, GxP and other harmonized (PIC/S, ICH) guidelines.
• Ability to write, review, and approve technical documentation with high attention to detail.
• Strong project management and organizational skills to manage multiple priorities.
• Excellent problem-solving skills with a proactive and solution-oriented mindset.
• Strong communication and interpersonal skills for effective collaboration across teams and with stakeholders.
• Ability to mentor, influence, and guide junior validation professionals.
• Proficiency in Microsoft Office Suite and familiarity with electronic documentation management systems (EDMS).

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Skills Required