Packaging Engineer

PACKAGING ENGINEER

Experis IT is Europe's leading IT recruitment agency. We are dedicated to connecting talented individuals with Business opportunities across a number of professional sectors, with IT being at the heart of our operations.

For one of our client, specialized in medical devices based in Schaffhausen, we are looking for a Packaging Engineer with experience in a regulated environment

This is a challenging contracting position starting in NOVEMBER UNTIL THE END OF OCTOBER 2018 with extension possibilities.

TASKS & RESPONSIBILITIES:

- 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 (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 degree in Engineering or related discipline or equivalent combination of education and work experience
- Minimum of 3 years of packaging engineering and/or design, or relevant experience
- Knowledge of packaging equipment is required
- Ability to interpret engineering drawings
- Secondary/Tertiary Material packaging experience is required
- Primary packaging material is a plus
- 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.
- Demonstrated experience in complying with one or more of the following is required: FDA CFR part 3, 4, 210, 211, and 820. Also ICH and industry technical standards relative to Combination Product development are a plus.
- Experience with FDA regulated Design Control, Change Control, CAPA, and ISO 13485,
- The ability to use statistic techniques when analysing data and make rational and logical decision based on that analysis.
- The ability to lead and/or support multiple projects simultaneously is required.
- The ability to perform root cause investigations and write technical documents.
- In addition this position requires project management skills, as well as interpersonal communication skills.
- Fluent in written and spoken English. German is a plus

LOCATION: Schaffhausen

START DATE: 01.11.2017

If you are a result oriented PACKAGING ENGINEER currently looking for a challenging new position that applies to your skills, then we look forward to receive your application!