ProClinical is seeking a Packaging Engineer in Process Development (PD) on behalf of our client, one of the biggest biotechnology companies in the world. The candidate will report to the Senior Manager Engineering at its Label&Packaging site in the south west of the Netherlands. The company is has reached millions of patients around the world and is developing a pipeline of medicines with breakaway potential.
The Packaging Engineer will join a team of 5 Packaging Engineers, responsible for the introduction and lifecycle management of commercial packaging for final drug product presentations.
- Designing, qualification and implementation of secondary packaging components and / or configurations used for site operations and transportation packaging.
- You are working in a high-class pharmaceutical / GMP environment, writing documents according to the Good Documentation Practices is a significant part of this role.
- Coordinate or participate in multi-disciplinary projects related to packaging component changes or new packaging designs. Assist equipment engineers with the design, installation, and maintenance of packaging equipment as required.
- Create and revise packaging component specifications if required.
- Coordinate change of documentation according Change Control procedure.
- Provide accurate information for Bill of Material (BOM), Master Packaging Configuration (MPC) and Transport packaging configuration (TPC) to be used on site.
- Create technical reports such as User Requirements, Assessments and Protocols.
- Coordinate testing to be performed for packaging related studies impacting the site.
- Create, review and approve testing protocol and reports as required.
- Develop test material; coordinate test material order and inventory as required by studies.
- Assist and contribute to Site Acceptance Test (SAT) and may assist in establishing Equipment validation Documentation.
- Bachelor's degree or equivalent with minimum 3 -5 year experience working in a Package Development or Engineering equivalent environment
- Master's degree with minimum 1 - 2 year experience working in a Package Development or Engineering equivalent environment
- Experience in a pharmaceutical / GMP environment
- Fluency in English and Dutch, both in oral and written communication
- Good (technical) written and verbal communication skills
- Ability to work in multi-functional teams and adapt to rapidly changing environment
- Defines project timeframes and priorities based on project objectives and ongoing assignments
- Recognizes and escalates problems in a timely manner
- Occasionally work outside office hours
- Comprehensive understanding of materials used in packaging
- Good understanding of current Good Manufacturing / Documentation Practices
- Familiarity with validation processes and protocols
- Understanding of equipment used in the packaging industry
Please click on the Apply button. Please include a short note outlining why you are interested in the role and why you think you are suitable.
In case you have difficulty in applying or if you have any questions, please call Sayf Jabbar on +44 203 8281 920 or upload your CV on our website www.proclinical.com.
A full job description is available on request.
ProClinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.