Cleaning Validation Specialist
Viatris · Inverin
Mylan TeorantaViatris 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:
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.