Senior Packaging Engineer - Switzerland
Jocelyn Blackham is recruiting for a Senior Packaging Engineer to join an innovative medical device manufacturer based in Solothurn, Switzerland. The Senior Packaging Engineer position will be based at their state of the art facility in Central Switzerland and employed on a contract for 12 months. This role comes with an excellent hourly rate and a high possibility of extension.
The main purpose of the Senior Packaging Engineer will be to provide packaging engineering 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.
Further responsibilities of this Senior Packaging Engineer position will include:
- Collaborating on Packaging and/or Technical Operations initiatives as required, based on business needs.
- As required, designing and developing secondary/tertiary packages for optimal equipment and process compatibility, considering patient/end user preferences and limitations.
- Providing technical input for primary packaging equipment, materials and packages to the team in order to assure compatibility between primary and secondary packaging processes.
- Design transfer/technology transfer/commercialisation activities including process and equipment qualification (IQ/OQ/PQ).
- Collection of design transfer documentation for consideration within the Design History File
- Reviewing and approving 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.
- Providing support to physical & cold chain shipping studies, line trial, packaging material qualifications, child resistant requirements, human factor studies and patient centric design.
- Achieving timely resolution of secondary packaging project related operational deficiencies, as required.
- Participating in risk remediation/reduction and drive toward root cause and robust corrective action/preventative action to improve process reliability.
As a Senior Packaging Engineer, you will have the following qualifications, skills and experience:
- Knowledge of packaging equipment is required.
- The ability to interpret engineering drawings is required.
- Secondary/ Tertiary Material packaging experience is required
- Primary packaging material is a plus, package equipment qualification/validation knowledge 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.
- Qualified to degree or equivalent level in Mechanical engineering or a related subject.
- Fluent in written and spoken English. German is a surplus.
- Demonstrated experience in complying with one or more of the following is required: FDA CFR part 3, 4, 210, 211, and 820.
- Experience with FDA regulated Design Control, Change Control, CAPA, and ISO 13485, The ability to use statistic techniques
For more information or to apply for this Senior Packaging Engineer position, please contact Jocelyn Blackham on +41 (0) 417276793 or email jblackham@ckqls.ch. Alternatively, please click on the link below to apply online now. Please note that your CV should show exact dates of employment (month and year) and any gaps of a month or more should be explained.
CK QLS is an Equal Opportunities employer and welcomes applications from all who meet our selection criteria.
If you do not hear back from us within 5 working days of your application for this role, it means that on this occasion you have not been short listed for the next stage of the recruitment campaign. Please quote reference QLS41207 in all correspondence.