Subject Matter Expert / Project Engineer Secondary Packaging 30473 (m/f)

REFERENZNUMMER:

363847/11

IHRE AUFGABEN:

-Collaborate on packaging and/or technical operations initiatives as required, based on business needs
-As required, design and develop secondary/ tertiary packages for optimal equipment and process compatibility, considering patient/end user preferences and limitations Provide technical input for primary packaging equipment, materials and packages to the PDMS team in order to assure compatibility between primary and secondary packaging processes
-Design transfer/technology transfer/commercialization activities, including process and equipment qualification (IQ/OQ/PQ)
-Collection of design transfer documentation for consideration within the Design History File
-Review and approve the following packaging documents: packaging component specifications, Packaging Bills Of Materials, packaging component drawings, design history files (for combination products), Technical Design Requirements (TDRs), risk/criticality assessment and procedures for bulk and finished drug product
-Authoring of technical development/transfer plans for secondary/tertiary packaging project
-Preparation and oversight of packaging development activities including preparation and organization of transportation studies
-Provide support to physical & cold chain shipping studies, line trial, packaging material qualifications, child resistant requirements, human factor studies and patient centric design
-Achieve timely resolution of secondary packaging project related operational deficiencies, as required
-Participate in risk remediation/reduction and drive toward root cause and robust corrective action/preventative action to improve process reliability

IHRE QUALIFIKATIONEN:

-Minimum bachelor’s degree in Engineering or a degree in Mechanical, Biomechanical or Materials
-Profound experience in packaging engineering and/or design
-Fluency in English, German is beneficial
-Broad scientific or engineering expertise with demonstrable results to deliver new products or sustain existing products
-Secondary/tertiary material packaging experience is required, primary packaging material is beneficial, package equipment qualification/validation knowledge is of advantage
-Understanding of cGMP, Good Documentation Practices and regulations is required
-Knowledge of temperature control/cold chain distribution and its application to pharma & medical device products is preferred
-Experience in FDA CFR part 3, 4, 210, 211, and 820
-Also ICH and industry technical standards relative to Combination Product development are of advantage

WEITERE QUALIFIKATIONEN:

Assistant to the head of production