Are you looking for a change of pace? Then hit the ground running with Dynavax!
Over the past 30 years, Dynavax has proven its innovative potential in developing and manufacturing biopharmaceuticals. Our production processes follow the highest quality standards. This is true for all our products, including our new Hepatitis B vaccine Heplisav™ (currently undergoing clinical trials in the US). We are seeking an experienced Specialist Plant Engineering (m/f) who will report to the Plant Engineering Manager.
You will work on cross-functional project teams, providing engineering support for the Clean Utilities, Facilities, Automation and Calibration / Maintenance departments at the Düsseldorf Manufacturing Facility.
In this role, you will be responsible for maintaining ongoing compliance within the Plant Engineering group for deviations, CAPAs and Change Controls. You will also be a Plant Engineering representative throughout the project lifecycle of launching equipment as well as initiation, design, construction, implementation, commissioning and qualification of new equipment.
Your scope of duties:
Maintaining ongoing compliance within the Plant Engineering group (Clean Utilities, Facilities, Automation and Calibration and Maintenance departments) for deviations, CAPAs and Change Controls
Collaboration with peers in the continuous improvement of technical infrastructure, including engineering standards, practices, specifications, procedures and business processes
Provide support and / or ownership for Clean Utilities, Facilities, Automation and Calibration / Maintenance projects
Maintenance and auditing of engineering documentation such as PFDs, P&IDs, URSs, Design Specifications, RFQs, contractor bid packages, equipment data sheets, piping isometrics, and Installation & Operational Qualification
Oversight and coordination of construction contractors
Monitoring and trending of process data
Process engineering support in investigations and CAPAs
B.Sc. in Chemical Engineering or equivalent with 1-2 years pharmaceutical industry or related experience
Strong proficiency in engineering principles and techniques, and demonstrated ability in successfully applying that knowledge
Project experience in pharmaceutical manufacturing facilities
Comprehensive GMP Skills and Knowledge of pharmaceutical standard regulations (EU GMP Guidelines, CFR, AMWVH etc.)
Strong technical leadership, able to work independently or as part of a multidisciplinary team
Effective communication and interpersonal skills with technical, operations, maintenance, quality and senior management personnel
Excellent problem-solving skills, strong analytical thinking and documentation skills
Very good English language skills.
Are you ready to work in a challenging, but also dynamic and growing environment?
Then submit your application and make a difference in a position that gives you room to grow. We offer a competitive compensation package including benefits, a flat hierarchy and many opportunities for professional development. We look forward to hearing from you.