Description
We are looking for a
Senior Packaging Engineer (m/f)
Reference: -en
Start: asap
Duration: 12 MM+
Place: in the Schaffhausen region
Branch: Herstellung von pharmazeutischen Spezialitäten und sonstigen pharmazeutischen Erzeugnissen
Your tasks:
- 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 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 towards root cause and robust corrective action/preventative action to improve process reliability
Your qualifications
- Bachelor’s degree in Engineering or related discipline or equivalent combination of education and work experience; degree 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
Skills:
- Quality manager
Keywords: This position requires a minimum of 3 years of packaging engineering and or design or relevant experience is required.