Description
We are looking for a
Subject Matter Expert / Project Engineer Secondary Packaging 30473 (m/f)
Reference: -en
Start: ASAP
Duration: 12 MM++
Place: in Schaffhausen
Branch: Unternehmensberatung
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/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
Your qualifications
- 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
Skills:
- Assistant to the head of production