Cleaning Validation Specialist

1100 Mylan Pharmaceuticals Inc.; Galway; On-site; EUR 55,000 - 75,000; Full time

Job summary

Viatris in Ireland's Galway site is seeking a Cleaning Validation Specialist within Manufacturing Science and Technology. You will lead cleaning validation activities, design studies, and support investigations across multi-product facilities to ensure compliant, high-quality manufacturing.

The role requires a science degree with pharmaceutical experience, knowledge of MACO concepts, sterile facility exposure, and strong technical writing and cross-functional collaboration.

Qualifications

• A degree in a science discipline with at least 3 years pharmaceutical experience.
• Sterile facility experience an advantage.
• Working experience in cleaning validation.
• Working knowledge of cleaning validation concepts including swab/rinse sampling procedures, MACO methodology.

Responsibilities

• Assume responsibility as the Subject Matter Expert for the facility.
• Coordinate and execute cleaning validation activities for assigned projects (standard yearly activities and clean/dirty hold times).
• Developing and maintaining the cleaning validation matrix for a multi-product facility.
• Preparation of cleaning validation documentation as required (protocols, reports and annual reviews).
• Coordinate and support investigations.
• A motivated and flexible self-starter operating with minimum supervision and managing tasks through to completion as well as coaching team members.
• Excellent communication skills with ability to exchange ideas and information effectively in a concise and logical way.
• Demonstrated strong team-working skills including ability to work and influence effectively across functions on and off site.
• Continuous improvement mindset with a Positive, can-do attitude.

Skills

Technical writing

Data analysis

Cross-functional work

Problem solving

Quality investigations

Education

Science degree in a related field

Job description

Mylan Teoranta Viatris is a global healthcare company uniquely positioned to bridge the traditional divide between generics and brands, combining the best of both to more holistically address healthcare needs globally.

With a mission to empower people worldwide to live healthier at every stage of life, we provide access at scale, currently supplying high-quality medicines to approximately 1 billion patients around the world annually and touching all of life's moments, from birth to the end of life, acute conditions to chronic diseases.

We have been included on number of award lists that demonstrate the impact we are making.

Every day, we rise to the challenge to make a difference and here’s how the Cleaning Validation Specialist role in Manufacturing Science and Technology will make an impact:

How the Cleaning Validation Specialist role will make an impact:

• Employing sound technical expertise to support manufacturing
• Supporting change management through technical risk assessment and running technical studies as required
• Capability to design experiments by employing quality by design principles to run scientific protocols to investigate deviations in manufacturing
• Strong scientific focus with a curious mind to identify improvement opportunities to reduce product variability overall
• Strong ability to analyse technical data from multiple sources in a methodical manner
• Strong technical writing capability to write high quality scientific protocols and reports including critical review of data to form sound scientific recommendations and conclusions
• A track record of developing innovative and creative solutions to complex and challenging problems working across different functional teams both internally and externally
• Key participant in manufacturing quality investigations supporting through product impact assessments and running technical studies as required
• Providing technical support to new product introduction and product transfers
• Support continuous process verification and working with impacted functions to address any trends observed

Key responsibilities for this role include:

• Assume responsibility as the Subject Matter Expert for the facility
• Co-ordinate and execute cleaning validation activities for assigned projects (standard yearly activities and clean/dirty hold times)
• Developing and maintaining the cleaning validation matrix for a multi-product facility
• Preparation of cleaning validation documentation as required (protocols, reports and annual reviews).
• Co-ordinate and support investigations
• A motivated and flexible self-starter operating with minimum supervision and managing tasks through to completion as well as coaching team members
• Excellent communication skills with ability to exchange ideas and information effectively in a concise and logical way.
• Demonstrated strong team-working skills including ability to work and influence effectively across functions on and off site
• Continuous improvement mindset with a Positive, can-do attitude

The minimum qualifications for this role are:

• A degree in a science discipline with at least 3 years pharmaceutical experience (academic or industry acceptable).
• Sterile facility experience an advantage.
• Working experience in cleaning validation.
• Working knowledge of cleaning validation concepts including swab/rinse sampling procedures, Maximum Allowable Carryover (MACO) methodology

At Viatris, we offer competitive salaries, benefits and an inclusive environment where you can use your experiences, perspectives and skills to help make an impact on the lives of others.

Viatris is an Equal Opportunity Employer.

At Viatris, we offer competitive salaries, benefits and an inclusive environment where you can use your experiences, perspectives and skills to help make an impact on the lives of others.

Viatris is an Equal Opportunity Employer.

Viatris is a global healthcare company formed in 2020 through the combination of Mylan and Upjohn, a legacy division of Pfizer. By integrating the strengths of these two companies, including our global workforce, we aim to deliver increased access to affordable, quality medicines for patients worldwide, regardless of geography or circumstance. We believe in healthcare as it should be – empowering people worldwide to live healthier at every stage of life. Because of our unwavering belief that better access leads to better health, we leverage our best-in-class manufacturing and scientific expertise and proven commercial capabilities to bring quality medicines to patients when and where they need them.