ProClinical is currently recruiting for a Validation Engineer job at a leading multinational biopharmaceutical company with leading therapies in autoimmune diseases and oncology. They are seeking an individual to bring solid validation experience their team at their offices in Breda, Netherlands. This is an exciting opportunity to work for one of the world's biggest biotechnology firms that employs over 17,000 staff globally. The Packaging / Validation Engineer will join a team of 5 Packaging Engineers, responsible for the introduction and lifecycle management of commercial packaging for final drug product presentations.
- Coordinate or participate in multi-disciplinary projects related to packaging component changes or new packaging designs.
- Develop test material; coordinate test materials and inventory as required by studies.
- Creation of Qualification and Verification Plans
- Coordinate testing to be performed for packaging related studies impacting the site.
- Assist and contribute to Site Acceptance Test (SAT) and may assist in establishing Equipment validation Documentation.
- Writing documents according to the Good Documentation Practices is a significant part of this role.
- Create technical reports such as User Requirements, Assessments, Protocols, Reports, Verification Documentation.
- Create and revise packaging component specifications if required.
- Provide accurate information for Bill of Material (BOM), Master Packaging Configuration (MPC) and Transport packaging configuration (TPC) to be used on site.
Skills and Requirements:
- Bachelors degree or equivalent with minimum 3 -5 year experience working in a Package Development and/or Validation/Engineering environment
- Masters degree with minimum 1 - 2 year experience working in a Package Development and/or Validation/Engineering environment
- Experience in a Pharmaceutical / GMP environment
- Good understanding of current Good Manufacturing / Documentation Practices
- Fluency in English, 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
- Additional preferred Requirements:
- Comprehensive understanding of materials used in packaging
- 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 Ivan Gitardi on +44 203 0789 551 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.