Senior Specialist, Computerized Systems Validation (CSV) (Morrisville)

Recruiters please do not contact this job poster. Please be advised : Solvias does not accept unsolicited resumes or services from third-party recruitment agencies. In the event, a recruiter or agency submits a resume or candidate without an agreement we shall explicitly reserve the right to pursue and hire those candidate(s) without any financial obligation to the recruiter or agency. Any unsolicited resumes, including those submitted to Company employees, shall be deemed the property of the Company.

Solvias is a global provider of chemistry, manufacturing, and control (CMC) analytics to the life sciences industry. Our expert team combines decades of experience with regulatory expertise across small molecules, biologics, and cell and gene therapies. Solvias offers end-to-end solutions from raw material testing to drug product release and API development for small molecules. Headquartered near Basel, Switzerland, Solvias operates six global Centers of Excellence, all adhering to the highest ISO, GMP, GLP, and FDA standards.

Position Overview

Located at our large molecule headquarters in RTP, North Carolina, the Sr. Specialist, CSV position will join the Quality Assurance team in supporting quality operations for Large Molecule & Advanced Therapy Medicinal Products (ATMP) testing services in a Good Manufacturing Practices (GMP) laboratory environment.

This is a fully onsite role reporting to the Qualification Validation Manager.

Critical Performance Areas

• Ensure work is executed in compliance with GMP regulatory requirements and SOPs, such as 21 CFR Part 11, Annex 11, ICH E6 R2, OECD Advisory Document 17, applicable Predicate Rules, etc.
• Interpret technical information with a focus on quality using industry-accepted risk-based approaches.
• Work across multiple quality processes within the QMS to support daily operations and ensure delivery of reliable data to clients.
• Provide timely and effective communication to impacted stakeholders across different functional areas.
• Contribute to continuous improvement of quality and business processes and represent a culture of quality at the site.

Essential Job Functions

Requirements

Other Desired Skills / Abilities

NOTE : This job description is not intended to be all-inclusive. Individuals may perform other related duties to meet the ongoing needs of the organization.

Disclaimer : Solvias North America, LLC does not currently offer relocation packages or sponsor work visas. All applicants must have the legal right to work in the location of the job posting.