Senior Packaging Engineer (m/f)

REFERENZNUMMER:

320932/11

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 and commercialization activities including process and equipment qualification (IQ/OQ/PQ)
-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 and Transfer Plans for Secondary/Tertiary Packaging project; Collection of design transfer documentation for consideration within the Design History File
-Preparation and oversight of packaging development activities including preparation and organization of transportation studies
-Provide support to physicaldegree in Mechanical, Biomechanical or Materials Engineering is preferred
-Broad scientific or engineering expertise with demonstrable results to deliver new products or sustain existing products; process excellence certification is also preferred
-Secondary/tertiary material packaging experience is required, primary packaging material is of advantage, package equipment qualification/validation knowledge is beneficial
-Knowledge of packaging equipment is required as well as ability to interpret engineering drawings
-Understanding of cGMP, Good Documentation Practices and Regulations as well as experience with FDA regulated Design Control, Change Control, CAPA and ISO 13485 is required
-Demonstrated experience in complying with one or more of the following is required: FDA CFR part 3, 4, 210, 211, and 820; ICH and industry technical standards relative to combination product development are beneficial
-Ability to lead or support multiple projects simultaneously is required as well as ability to perform root cause investigations and write technical documents
-Knowledge of temperature control/cold chain distribution and its application to pharma & medical device products is preferred
-Ability to use statistic techniques when analyzing data and make rational and logical decision based on that analysis
-Fluent in written and spoken English, German is of advantage

WEITERE QUALIFIKATIONEN:

Quality manager