Cleaning Validation Specialist

About the company

Viatris is a worldwide healthcare organization formed to connect the worlds of generics and branded medicines. Its purpose is to help people everywhere live healthier lives at every stage, and it supplies quality medicines to around 1 billion patients each year, supporting needs from birth through chronic and acute care.

The company has also been recognized on several award lists that reflect its broader impact.

Role overview

The Cleaning Validation Specialist within Manufacturing Science and Technology will play an important role in supporting manufacturing operations, validating cleaning processes, and helping maintain product quality across a multi-product facility in County Galway, Ireland.

Technical contribution

• Apply strong technical knowledge to assist manufacturing activities.
• Support change management by assessing technical risk and carrying out studies where needed.
• Build and execute scientific experiments using quality-by-design thinking to study manufacturing deviations.
• Use a strong scientific mindset to spot opportunities that may reduce product variability.
• Review technical data from several sources in a structured and systematic way.
• Prepare high-quality scientific protocols and reports, critically evaluate data, and draw clear scientific conclusions.
• Contribute innovative solutions to difficult problems while working with internal and external cross-functional teams.
• Support manufacturing quality investigations, including product impact assessments and technical studies.
• Provide technical support for new product introductions and product transfer activities.
• Assist with continuous process verification and help relevant teams address observed trends.

Key responsibilities

• Act as the subject matter expert for the facility’s cleaning validation activities.
• Plan, coordinate, and carry out cleaning validation work for assigned projects, including annual requirements and clean/dirty hold time studies.
• Maintain the cleaning validation matrix for a site that produces multiple products.
• Prepare cleaning validation documents such as protocols, reports, and annual review files.
• Coordinate and support investigations linked to cleaning validation.
• Work independently with minimal supervision, manage tasks through to completion, and help coach colleagues when needed.
• Communicate clearly and concisely, sharing ideas and information in a logical manner.
• Work collaboratively across functions, both on site and off site, and influence others effectively.
• Bring a continuous-improvement approach and a positive, proactive attitude to the role.

Requirements

• A degree in a science-related discipline.
• At least 3 years of experience in the pharmaceutical industry; academic or industry background is acceptable.
• Experience working with cleaning validation.
• Knowledge of key cleaning validation methods, including swab and rinse sampling and Maximum Allowable Carryover (MACO) methodology.
• Sterile facility experience is an advantage.

Additional information

Viatris offers competitive pay, benefits, and an inclusive workplace where employees can use their experience, perspective, and skills to contribute to better health outcomes. The company is an equal opportunity employer.

Location

County Galway, Ireland. The role is onsite.