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 (Senior) CSV Engineer who will ensure that our computerized systems always have the green light.
Your scope of duties:
You keep our systems running smoothly and error-free by performing installation, operational and performance qualifications (IQ, OQ, PQ) on new and modified systems and equipment. To achieve this goal, you guide the computerized system validation activities for diverse equipment and systems with a steady hand. This primarily includes QC instrumentation, manufacturing equipment and direct impact software systems. You record all steps and results in validation protocols and reports.
You work according to all relevant GAMPs for computerized systems (e.g. creation of functional and design specifications, risk assessments, IQ / OQ / PQs, annual reviews). You also uphold all site SOPs and regulatory guidelines. On this basis, you follow and apply the life cycle approach.
In cooperation with stakeholders from other departments (incl. QA, QC, Plant Engineering), sites and external vendors, you seek joint solutions for validation projects and deliverables.
You have a degree in a science-related discipline
You have profound knowledge of CSV and experience in a pharmaceutical / biopharmaceutical GMP environment
You are a team-oriented person who can manage multiple projects and tasks with a goal-oriented, yet flexible approach
You have good communication, interpersonal and training skills as well as the ability to establish collaborative relationships in both English and German
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.