Description
Senior Packaging Engineer - Pharmaceutical productsWe have a new project for a senior packaging engineer to provide support to technical design and standards for packaging equipment, secondary/ tertiary packaging technical transfer and new product launch projects for all manufacturing projects.
RESPONSIBILITIES:
* Collaborate on Packaging and/or Technical Operations initiatives as required, 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 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 (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.
Requirements:
bachelor's degree in Engineering or related discipline .
Prior packaging engineering and design, or relevant experience is required.
broad scientific or engineering expertise with demonstrable results to deliver new products or sustain existing products.
Knowledge of packaging equipment is required.
The ability to interpret engineering drawings is required.
Secondary/ Tertiary Material packaging experience is required,
Understanding of cGMP, Good Documentation Practices, and Regulations is required.
The ability to lead and/or support multiple projects simultaneously is required.
The ability to perform root cause investigations and write technical documents.
Experience with FDA CFR part 3, 4, 210, 211, and 820, ISO 13485,
Michael Bailey International is acting as an Employment Business in relation to this vacancy.