Process Engineer (m/f/d)

About the company

Shape robust manufacturing processes – GMP-compliant, efficient, and customer-focused in a pharmaceutical CDMO environment.

This role offers the opportunity to work on complex pharmaceutical products, collaborate with international customers, and contribute to the successful launch of new medicines in a dynamic CDMO environment.

Your tasks

As a Process Engineer (m/f/d), you will play a key role in introducing new products and optimizing existing manufacturing processes at our pharmaceutical production site. You will ensure that customer requirements, product dossiers, technical feasibility, and regulatory requirements are translated into robust, scalable, and GMP-compliant processes.

Working within cross-functional project teams and in close cooperation with Project Management, Manufacturing, Technology Transfer, Quality, Engineering, Supply Chain, Regulatory Affairs, and customers, you will support products from feasibility assessment through engineering, process validation, and commercial manufacturing.

• Assess the technical feasibility of new products and provide manufacturing and process input for quotations and RFQs.
• Plan and execute product transfers in close cross-functional collaboration with Manufacturing, Quality, Engineering, Supply Chain, EHS, and customers.
• Review technical product and process requirements and translate them into robust, site-appropriate manufacturing processes.
• Identify technical risks and gaps and define appropriate actions related to processes, equipment, batch sizes, and site requirements.
• Prepare and maintain relevant manufacturing, process, equipment, and validation documentation and support engineering, pilot, and validation activities.
• Provide technical support during manufacturing and ensure GMP-compliant implementation of processes, changes, qualifications, and validations, while communicating key technical topics to internal and external stakeholders.

Requirements

• A university degree in process engineering, pharmaceutical engineering, chemical engineering, biotechnology, or a comparable technical or scientific discipline.
• At least 2 years of professional experience in pharmaceutical manufacturing, process engineering, technology transfer, or a comparable regulated production environment.
• Sound knowledge of GMP, process validation, risk assessments, change control, deviation management, and technical documentation; experience with manufacturing equipment and scale-up is an advantage.
• Very good German and English skills and proficiency in MS Office; experience with pharmaceutical documentation or quality systems is desirable.

What Makes You a Great Fit

• A structured and analytical approach with a strong awareness of quality and safety
• Strong technical understanding for assessing process data, risks, and deviations
• The ability to collaborate closely with Manufacturing, Quality, Engineering, and other interfaces
• A professional manner when working with customers and internal stakeholders
• A high level of initiative, organizational strength, and coordination skills
• A solution-oriented mindset focused on continuous improvement in a regulated manufacturing environment.

What we offer

• 30 days of annual leave based on a 40-hour working week
• BusinessBike after successful completion of the probationary period
• Complimentary beverages and coffee
• Varied and engaging responsibilities in an international pharmaceutical company
• Individual development and training opportunities
• A collaborative working environment with short decision-making paths and room for your own ideas

How to apply

We look forward to receiving your application and getting to know you!