Pharmaceutical Process Engineer
Location: GermanySIRE 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 COMPANY
Our client is a professional Biotechnology and Pharmaceutical organization, based in Baden-Württemberg Germany.
World-Leading Pharmaceutical Company
ROLE DESCRIPTION
The process scientist will work within MES Operations with the objective of providing support for all current and future
products
- Contributes to process of manufacture of existing and new products, and all aspects of a product life cycle, including
development, registration, clinical and commercial manufacture, especially with a focus on manufacturing process,
scale-up, current and innovative new technologies, equipment, statistical analysis and mechanical / thermal process
engineering
- Support the Bulk manufacturing department and Site KPI’s
- The role will also support all aspects of new technology introduction, plant performance, process improvements, GMP
compliance and troubleshooting as part of the product support role during the commercial life span of the product.
- Must be self-motivated and be capable of working without supervision
RESPONSIBILITIES
Responsibilities:
- Provide the scientific support suitable for the evaluation of novel manufacturing processes
- Generate test data to characterise trial processes and to facilitate product support according GMP requirements
- Technology input on novel technologies on existing and future products
- Investigation of the events that may have an impact on product quality
- Support/generation of the annual product review for products
- Generation or update of production batch records
- Support the introduction of new products
- Trending of process data and correction of product issues including statistical analysis
- Support Plant Performance Activities on site in particular CIPs (Cost Improvement Projects)
- Support Process Optimisation activities
- Be familiar with the products, the manufacturing techniques and procedures.
- Create, update or ensure Production Batch Records and SOPs are kept updated and in compliance with GMP and
regulatory filing.
- Implement and maintain manufacturing processes and associated systems in compliance with GMP and regulatory
requirements
REQUIREMENTS
- Engineer (Master, Dipl Ing) in Chemical, BioChemical, Pharmaceutical Specialty or equivalent experience.
- 1-3 yrs experience in pharma environment, especially manufacturing
- Experience with troubleshooting manufacturing processes and industrial scale equipment.
- Experience working in a cGMP environment.
- Previous experience in Product Development, CTS or supervisory experience in a busy production environment is a
requirement.
- Judgment, initiative, concern for excellence, providing direction, technical skill & competence, teamwork & problem
analysis, driving the business, statistical analysis
- Strong written and verbal communication skills
- Fluency in English is requirement in order to communicate with required colleagues globally
Are you interested and do want to apply for this role, please fill out your application via the apply button below and contact Robbert Roos.