RRxCo is partnered with a UK-based business established in 2010 focusing on antibody, protein, and peptide drug conjugate medicines and technology.

The bioconjugation team was formed in 2011 and moved into a state-of-the-art facility in 2018.

The facility has been built for containment; with the safety of their people and the environment in mind, and bespoke laboratories have been designed specifically to accommodate highly potent bioconjugations.

Antibody Drug Conjugates combine the cell and tissue specificity of monoclonal antibodies with the cell-killing potential of highly potent small molecules and represent one of the fastest-growing sectors in the oncology field.

Position Overview

The Manager of Validation Processes will be responsible for ensuring that all validation activities are conducted in compliance with regulatory requirements and within specified timelines.

This individual will own and manage the site's validation system, including the Site Validation Master Plan, and be actively involved in the validation of various equipment and systems.

Key Responsibilities
• Create and manage standard operating procedures (SOPs).
• Write or oversee the writing of validation protocols.
• Support protocol execution when performed by other departments.
• Manage and review qualification work completed by vendors and subcontractors.
• Write or supervise the preparation of associated validation reports.

Additionally, the Manager will be expected to:
• Author other essential documentation, including technical reports and risk assessments, while assisting in problem-solving and process improvements.
• Provide compliant validation for facilities, equipment, utilities, products, and processes in accordance with regulatory standards.
• Collaborate with key stakeholders, including QC, production management, and QA, to ensure timely documentation of validation activities.
• Participate in project teams, communicating plans, progress, and any issues that arise.
• Produce vital documents such as URS, DQ, FAT, SAT, IQ, OQ, and PQ to support equipment qualification, product development, and production projects.
• Document any anomalies and assist in their resolution.

Health, Safety, and Environment (HSE)
• Comply with all HSE policies and procedures.

Candidate Profile
• Minimum of 4 years’ proven experience in the pharmaceutical or a related industry.
• At least 3 years of hands-on experience in a validation role within a pharmaceutical or biopharmaceutical environment, focusing on equipment qualification (both simple and complex equipment, including laboratory and manufacturing equipment).
• Thorough understanding of cGMP validation requirements.
• Experience in performing equipment qualification.
• Proficiency in Microsoft Office Suite (Word, Excel, PowerPoint) with strong formatting skills.
• Knowledge of GMP & GLP systems.
• Familiarity with GMP validation requirements and guidance documents.
• Strong understanding of quality systems, data integrity, and quality risk management.
• Excellent attention to detail, particularly in documentation reviews.
• Effective communication skills, with the ability to build strong working relationships across all levels of the organization.
• Approachable and friendly demeanor, with the confidence to constructively challenge results when necessary.

Preferred Qualifications
• Expertise in Computer System Validation (CSV).
• Experience in cleanroom validation.
• Familiarity with electronic documentation management systems.

Join us in our mission to advance antibody drug conjugates and contribute to breakthrough therapies within our innovative facility.