Viatris Pharmaceuticals LLC

　　At VIATRIS, we see healthcare not as it is but as it should be. We act courageously and are uniquely positioned to be a source of stability in a world of evolving healthcare needs.Viatris empowers people worldwide to live healthier at every stage of life.We do so via:

　　Access - Providing high quality trusted medicines regardless of geography or circumstance;

　　Leadership - Advancing sustainable operations and innovative solutions to improve patient health; and

　　Partnership - Leveraging our collective expertise to connect people to products and services.

　　Every day, we rise to the challenge to make a difference and here's how the Technical Services Specialist - Pkg role will make an impact:

　　Responsible for identifying and implementing pharmaceutical equipment improvements of current marketed products. Validation of packaging process changes, new equipment, and products. Troubleshooting of products packaging processes and equipment to follow GMP, safety and process standards.

　　Key responsibilities for this role include:

　　Leadership and Administrative

　　Establishes and lead multidisciplinary teams to implement projects initiatives and reports results.

　　Communicates and agree with Manufacturing, Engineering & Materials departments the installation of equipment, protocols executions, experiments, and trials.

　　Recommends and executes employee training to assure process / equipment understanding and control process

　　Provides project and operational support in the areas of Packaging processes, equipment, and component engineering.

　　Support new products, package presentation changes and product transfers. Review and develop related project documentation (SCR, TPP, CR, PCP / PCR, etc).

　　Coordinate supply of Clinical and Stability samples as well as packaging requirements for new product

　　Manage Validation Lifecycle (PBO/SOP/IQ/OQ/PQ/MVP).

　　Generates validation protocols, supervises the execution, and generates reports approvals for pharmaceutical equipment and cleaning processes.

　　Manage Package Component (Primary, secondary, or tertiary) Structural Development/Change Process (PCP/PCRs, Drawings, Specifications and PBOMs), and Package Component Evaluations (PCEs).

　　Lead and drive CIP projects, Methods, and Continuous Improvement initiatives.

　　Assists team members in process / equipment related projects.

　　Identifies improvement opportunities, new technologies & equipment.

　　Recommends equipment and process enhancements and implements the recommendations.

　　Prepares Capital Projects and purchase orders for new equipment acquisition related to validation exercise if applicable.

　　Proposes, executes, and reports results and recommendations of development experiments.

　　Initiates and justify required documentation to implement process and equipment improvement.

　　Initiates preventive measurements to maintain process control.

　　Identifies and implements continuous improvement activities related to process, equipment to assure quality and safety standards.

　　Review and develop related project documentation (CR, PCP / PCR, etc).

　　Coordinate supplier component samples, test packaging component procurement requests, and execute line trials.

　　Support OEE, RFT and Lean Manufacturing Projects.

　　Quality and Good Manufacturing Practices (G.M.P.)

　　Revises Production Orders (PDO) and or procedures to improve instructions clarity and process reliability.

　　Analyzes and investigates process deviations.

　　Designs and coordinates product quality improvements projects.

　　Conducts audits to manufacturing and packaging operations.

　　Identifies changes to processing set points, working limits, release limits etc., justify and proposed changes.

　　Prepares technical assessment to support manufacturing changes and or justify lot dispositions.

　　Budget and Financial

　　Analyzes, prepare, and submits capital forms for the projects implementation to obtain budget approval.

　　Prepares requests purchase orders and Authorization for Work (AFW) as part of project documentation.

　　The minimum qualifications for this role are:

　　Education

　　Bachelor's degree in engineering or packaging sciences

　　Experience

　　2-4 year of experience in pharmaceutical industries or related fields.

　　Strong knowledge of cGMP

　　Strong knowledge of RFT tools (Green Belt or Black Belt) is a must

　　Skills

　　Technical Skills

　　Technical writing

　　Analytical skills

　　Computer Literacy

　　Project Management

　　Competencies

　　Business Acumen

　　Managing multiple priorities

　　Communication skills

　　Negotiation skills

　　Leadership

　　Innovation and creativity

　　Strategic thinking and problem solving

　　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. All qualified applicants will receive consideration for employment without regard to race, national origin, religion, age, color, sex, sexual orientation, gender identity, gender expression, disability, or protected veteran status, or any other characteristic protected by local, state, or federal laws, rules, or regulations.

　　Mylan offers competitive salary, excellent benefits and an environment conducive to professional growth and advancement. All qualified applicants will receive consideration for employment without regard to their disability or protected veteran status. Mylan is an Equal Opportunity Employer, Minorities/Female/Disabled/Veteran.Â