Packaging Engineer – medical devices 12 months contract
We are looking for an experienced engineer to support to technical design and standards for packaging equipment, secondary/ tertiary packaging technical transfer and new product launch projects for all packaging sites and external contracting sites, as applicable.
Collaborate on Packaging and Technical Operations projects , based on business needs.
• 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 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).
• Compile 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 (TDR’s), 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.
• Participates in risk remediation/reduction and drive toward root cause and robust corrective action/preventative action to improve process reliability.
* broad scientific/ engineering expertise in new or marketed products.
* Knowledge of packaging equipment
* The ability to interpret engineering drawings
* Secondary/ Tertiary Material packaging experience,
* package equipment qualification/validation knowledge
* Understanding of cGMP, Good Documentation Practices, and Regulations
* Knowledge of temperature control/cold chain distribution and its application to pharma & medical device products
* The ability to perform root cause investigations and write technical documents.
* project management skills,
* bachelor’s degree in Engineering or related discipline or equivalent
* FDA CFR part 3, 4, 210, 211, and 820.
* Experience with FDA regulated Design Control, Change Control, CAPA, and ISO 13485,
* Fluency in English, German language is an advantage
Please send your CV
Michael Bailey International is acting as an Employment Business in relation to this vacancy.