**Work Schedule** Standard (Mon-Fri) **Environmental Conditions** Office **Job Description** **Steriles Packaging Development & Design – SOW DHF Role** The role is to be based at GSK’s R&D site in Upper Providence, Pennsylvania (US) and can offer flexible hybrid working. Occasional travel may be required. **Grade:** + Sr. Scientist / Investigator **Essential Qualifications:** + Bachelor’s degree in Packaging Engineering, Device Engineering, Packaging Science, Chemistry, Life Science, with 3+ years’ experience in parenteral or device package development, primarily in pharmaceutical industry + Design History File and Risk Management File experience in the pharmaceutical industry **Preferred Qualifications:** + Knowledge of integral and non-integral parenteral packaging materials (such as vials, stoppers, PFS, syringes, needles), components, vendors, analytical equipment, and technologies. + Experience in sterile drug primary packaging development for large and small molecules including vial/stopper, pre-filled syringes, and cartridges presentations. + Knowledge of domestic and international device and packaging requirements and regulations (i.e., current applicable FDA/MAA guidelines, USP/Ph Eur, etc, ISO). + Knowledge of statistical analysis and Design of Experiments + Ability to quickly establish relationships with internal and external stakeholders. + Strong time management / organizational skills. + Evidence of team working skills and flexibility. Work Summary: To author DHF(s) and RMF(s) for a non-integral co packed combination drug product in the UP, PA site. The task list outlined below provides a comprehensive summary of the crucial work that needs to be carried out in the Steriles Packaging Development team. This work is primarily aimed at projects related to Steriles ViiV projects in development at GSK. **Tasks:** + Support packaging and device development work streams for R&D combination and/or co-packaged product development projects. + Take ownership of device work packages, co-ordinate testing activities (e.g. verification, validation, Design of Experiments, robustness studies) to ensure device safety and performance. + Responsible for managing Design History File (DHF) documentation. + Author device development documentation including Design History Files (DHF) and Risk Management Files (RMF). + Use problem solving skills and utilization of different strategies to support resolution of design, manufacturing and regulatory challenges. + Collaborate with multi-disciplinary teams across GSK and international sub-contractors. + Participate in packaging and device risk assessments (e.g. user, design or process risk assessments). + Participate in design reviews at critical stages of development. + Work closely with the manufacturing organization and suppliers to ensure that methods and processes are transferred for commercial production (as needed). + Contribute towards continuous improvement activities to drive quality, efficiency and consistency. **Stretch Tasks:** + Writing templates for DHF and RMF for non-integral device packages + Leading or supporting AAR with team to identify continuous improvement efforts Thermo Fisher Scientific is an EEO/Affirmative Action Employer and does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability or any other legally protected status.