For our Client, a leading Biotech Company located at Düsseldorf, we are currently looking for this permanent position
Process Engineer / Senior Process Engineer (m/w/d)
- This position will be responsible for engineering optimization and expansion activities related to our biotechnology process equipment used in the manufacturing of drug substance (DS).
- The Process Engineer / Senior Process Engineer leads cross-functional project teams, provides engineering leadership and support for daily operations in our manufacturing process and in the delivery of investment projects at the Düsseldorf Manufacturing Facility.
- In this role, you will be involved throughout the project lifecycle of legacy process equipment as well as initiation, design, procurement, construction, implementation, commissioning and qualification of new process equipment.
- This position will report to the Head of Process Engineering. Strong cooperation is expected with our team in manufacturing, MST, reliability engineering, infrastructure, automation and validation.
- The Engineer (Process) is responsible for the process manufacturing equipment readiness, including related automation.
- Leads the technical transfer of process improvements from development to manufacturing
- Prepares investment requests (and associated feasibility studies and/or conceptual design works)
- Executes investment projects together with external contractors (basic design, detailed design, installation, commissioning, qualification, validation)
- Acts as lead to support daily manufacturing operations by using technical knowledge and analytical methods
- Supporting continuous improvement and optimization of manufacturing processes and associated process equipment
- Develop design, qualification and procurement documents such as PFDs, PIDs, URSs, Design Specifications, RFQs, contractor bid packages, equipment data sheets, instrument data sheets, piping isometrics, and Installation Operational Qualification packages for biopharmaceutical process equipment.
- Lead investigations and CAPAs for process equipment related deviations
- Collaboration with peers in the continuous improvement of technical infrastructure, including engineering standards, practices, specifications, procedures and business processes
- Interaction with external vendors contractor
- University degree (BSc or MSc in engineering or related discipline) and more than 5 years experience in the biotechnology field, with a proven track record in chemical, biochemical or mechanical engineering.
- Strong technical knowledge of biopharmaceutical manufacturing principles, techniques and equipment.
- Understanding of validation of biopharmaceutical facilities, equipment and processes.
- Project experience in pharmaceutical manufacturing facilities, leading the implementation of biopharmaceutical unit operations.
- Knowledge of GMP manufacturing requirements and pharmaceutical standard regulations (EU GMP Guidelines, CFR, AMWVH etc.).
- Strong root cause analysis skills for leading equipment related deviations.
- Enthusiastic team player with fluent communication skills in German and English.
- Effective communication and interpersonal skills with technical, operations, maintenance, quality and senior management personnel.
- Excellent problem-solving skills, good communicator, strong analytical thinking with excellent documentation skills.