MS&T Raw Materials and Validation Lead – Associate Director
Join a growing biologics drug substance manufacturing site in Dunboyne and play a key role in the methodology and governance of process, cleaning and shipping validation as well as raw material strategies that support reliable, compliant, and efficient manufacturing operations.
As the Raw Materials and Validation Lead, you will provide technical leadership across cleaning validation, process validation, shipping validation, and raw material management. Working closely with Manufacturing, Quality, Engineering, Supply Chain, and Technical Operations teams, you will drive validation excellence, strengthen technical standards, and support the introduction and lifecycle management of raw materials used in manufacturing.
This is an excellent opportunity for an experienced professional who enjoys solving complex technical challenges, influencing cross-functional teams, and driving continuous improvement in a regulated environment.
Bring energy, knowledge, and innovation to carry out the following:
- Serve as the site subject matter expert for process, cleaning and drug substance shipping validation in support of new product introduction and commercial manufacturing.
- Act as site expert for process validation lifecycle activities, including risk assessments, protocol development, execution, reporting, and ongoing process verification.
- Lead site-wide cleaning validation strategy and associated deliverables ,ensuring implementation to industry leading validation standards.
- Provide technical oversight to raw material selection, qualification, introduction, and lifecycle management.
- Lead or support investigations related to raw materials, coordinate the implementation of supplier initiated changes, and act as site expert defining the process impact and action plan.
- Lead or support investigations related to raw materials from pre-use to drug substance strorage.
- Ensure all validation activities remain inspection-ready and aligned with latest regulatory and quality expectations, supporting on-site inspections and engagement.
- Collaborate with cross-functional teams to ensure continuity of drug substance supply and robust technical decision-making.
- Identify opportunities to improve validation programs, raw material robustness, and operational efficiency across the site.
What Skills You Will Need
- Degree in Engineering, Biotechnology, Chemistry, Pharmaceutical Sciences, or a related scientific discipline.
- Significant experience within biologics, pharmaceutical, or sterile manufacturing in a regulated environment.
- Strong expertise in cleaning validation and process validation.
- Experience in shipping validation is highly desirable.
- Deep industry knowledge of validation principles, lifecycle management, and regulatory requirements.
- Experience supporting inspections, audits, and health authority interactions.
- Knowledge of raw material management, including material introduction, change management, technical assessments, and investigations.
- Strong understanding of quality risk management, deviation management, change control, and corrective and preventive action processes.
- Proven ability to lead and influence cross-functional teams and stakeholders.
- Strong decision-making, communication, and problem-solving skills.
- Continuous improvement mindset with a strong focus on quality, compliance, and operational excellence.
Required Skills:
Biologics, Cleaning Validations, Continuous Improvement, Cross-Team Collaboration, Decision Making, Decision Management, Deviations, Pharmaceutical Industry, Process Validation, Raw Material Management, Risk Management
