Posted: 18 June
The role
Senior Process EngineerEmploying 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 analyze 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, product transfers and alternate source qualifications.Support continuous process verification and working with impacted functions to address any trends observed.Key ResponsibilitiesAssume responsibility for technology transfer projects introduced into the facility.Plan, coordinate and execute exhibit and Process Performance Qualification batches as part of business requirements.Plan and execute product lifecycle projects including alternative API source qualification, processing hold times extensions and batch upscale.Preparation of cleaning validation documentation as required (protocols, reports and annual reviews).Coordinate and support manufacturing investigations.Self‑starter ability 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.Minimum QualificationsA degree in a science discipline with at least 3 years pharmaceutical experience (industry).Sterile facility experience.Proven experience in Process Performance Qualification.Experience in investigation and CAPA implementation.Preferred QualificationsExperience with aseptic filling machines.Experience with pharmaceutical compounding.Knowledge of single use systems (bonus).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.
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