SIRE Life Sciences® is the market leader in life science recruitment. We believe the recruitment market needs to gear up in technology and continues innovation. We like technology, in a life science market driven on science, we couldn’t stay behind; we drive Recruitment Science. Investing a majority of our turnover in technology enables us to use unique Resource Technologies. By using highly advanced algorithms, we enable our team of Resource & Data Strategists© to maintain the most advanced, detailed and complete Life Sciences network in Europe. This big data enables us to work Reverse Recruitment©: we first analyze the market in-depth before we go out to the market. Because we analyze the whole market, we can compare facts and data. This enables us to do Facts & Big Data Recruitment©, making sure we, or better yet, you find the right career!
The companyOur client is a professional Biotechnology and Pharmaceutical organization, based in Noord-Brabant Netherlands. You will be working at one of the early pioneers in the biopharmaceutical industry.
Role descriptionOur client is seeking a Validation Engineer in Process Development (PD) that will report to the Senior Manager Engineering at its Label&Packaging site in Breda, NL. 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.
You are working in a rapidly growing, high-class pharmaceutical / GMP environment. Main responsibilities are; designing, qualification/verification and implementation of secondary packaging components and / or configurations used for site operations and transportation packaging.
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.
RequirementsBachelor’s degree or equivalent with minimum 3 -5 year experience working in a Validation and/or Engineering environment
Master’s degree with minimum 1 - 2 year experience working in a Validation and/or 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