Overview
Join MSD as a Cleaning Validation Senior Specialist. This role offers a unique opportunity to develop your career in a fast-paced, innovative environment, working alongside industry experts who are passionate about science, technology, and continuous improvement.
Job Description
This role is critical to ensuring the facility maintains a state of validation and compliance with global regulatory standards. The Site Topic Lead (STL) for cleaning will support the introduction of new molecules, drive continuous improvement, and mentor junior team members of the Pharm Ops Team.
Responsibilities
* Act as the primary contact and Site Topic Lead (STL) for all cleaning-related matters.
* Represent the site in global cleaning forums and initiatives.
* Lead cleaning development and cleaning validation activities for new product introductions.
* Ensure cleaning processes meet regulatory expectations and internal quality standards.
* Maintain a validated state for all cleaning processes across the facility.
* Serve as the SME during internal and external audits (e.g., HPRA, FDA).
* Ensure documentation and practices are audit-ready and aligned with current Good Manufacturing Practices (cGMP).
* Identify and implement innovative cleaning strategies and technologies.
* Drive efficiency and effectiveness in cleaning processes.
* Navigate ambiguity and provide clear direction in complex scenarios.
* Coach and train junior staff and cross-functional teams on cleaning principles and practices.
* Develop and deliver training materials and sessions.
Qualifications / What Skills You Will Need
* Bachelor’s degree in Chemistry, Chemical Engineering, Pharmaceutical Sciences, or related field.
* Experience working within pharmaceutical manufacturing environment.
* Proven track record of working in cleaning roles in other pharmaceutical companies.
* Experience supporting regulatory inspections and maintaining validated cleaning states.
* Deep understanding of cleaning validation principles, risk assessments, and analytical methods.
* Strong leadership, communication, and stakeholder management skills.
* Ability to think strategically and execute tactically.
* Comfortable working in a dynamic, fast-paced environment with evolving priorities.
* Experience with small molecule API and drug product manufacturing including high potency.
About MSD and Working Arrangements
We are an equal opportunity employer and value bringing diverse, talented, and committed people together. We are committed to flexible working where possible, including a hybrid working model for office-based colleagues around the world. Please feel free to discuss what flexibility means to you during your application.
Job Details
* Employment type: Full-time
* Job function: Production, Manufacturing, and Engineering
* Industries: Biotechnology Research, Pharmaceutical Manufacturing, and Veterinary Services
* Seniority level: Not Applicable
* Location: Waterford, Ireland (hybrid/work from home options may apply)
Application and End Date
Job Posting End Date: 09/10/2025
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