Qualification Validation Specialist

Job Description

Solvias is an internationally recognized provider of integrated solutions in contract analytical research, development, and manufacturing. The company offers a broad spectrum of services and solutions in the Pharmaceutical, Biotech, Medical Device, Cell & Gene Therapy (CGT), and Cosmetic industries. With headquarters near Basel, Switzerland about 800 highly qualified employees take pride in putting science at the heart of serving customers to bring safer and better products to market faster.

Located at our large molecule headquarters in RTP, North Carolina, the Qualification Validation Specialist serves as a Subject Matter Expert (SME) for the Qualification Validation Management (QVM) function within the Quality Assurance (QA) department. The position is an onsite role at our new facility for Large Molecule & Advanced Therapy Medicinal Products (ATMP) testing services in a Good Manufacturing Practices (GMP) laboratory environment in Morrisville, NC.

• Assists with the establishment, performance and maintenance of proper equipment/instrument and method validation/transfer/verification activities and documentation per corresponding internal and regulatory requirements.
• Serve as an SME for equipment qualification and maintenance within Quality Assurance, as well as for proper equipment qualification life cycle management and compliance oversight for shared systems (e.g., LIMS, Empower, etc.).
• Advises and assists with preparation and review of equipment service agreements, user requirement specifications (URS), installation/operational/performance qualification (IQ/OQ/PQ) documentation, risk assessments and other qualification documents.
• Perform and assist with compliance activities relating to method validation, transfer, and verification.
• Assist with compiling and tracking qualification and validation item status, associated metrics, and quality management system processes (e.g., process change control, quality events/deviation, CAPA, audit observations, etc.).
• Support continuous improvement in QVM and associated processes

Requirements

• Bachelor’s degree in a technical, scientific, or other relevant discipline.
• Minimum of 2 years of experience in a qualification and validation role in a pharmaceutical/biotechnology environment. Experience within a contract research or manufacturing development organization (CRO, CDMO) is a plus.
• Familiarity with various types of laboratory equipment (cell-based bioassay, physical chemistry, molecular biology, virology).
• Working knowledge of US and EU GMP regulations for equipment qualification, maintenance, method validation/transfer and corresponding compliance systems.
• Familiarity with biologics and/or pharmaceutical Quality Management Systems and regulations.
• Knowledge of Data Integrity rules and requirements.
• Experience in writing validation protocols and reports.

Other Desired Skills/Abilities

• Familiarity with Quality and laboratory systems such as Labware LIMS, MasterControl, Empower, Chromeleon.
• Willingness to learn and carry out new and complex tasks.
• Ability to work both independently and collaboratively with internal and external stakeholders.
• Knowledge of word processing, spreadsheet, and database applications.
• Excellent analytical and problem-solving skills.
• Strong attention to detail and organizational abilities.
• Effective communication and interpersonal skills.

Reporting Structure

This job reports to:

• Director, Quality and Quality Systems or Qualification Validation Manager

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 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.

Apply Now