Process Engineer for New Product Pipeline & Risk Analysis in Sterile Pharma Manufacturing - Freelancer

Location(s): Frankfurt

Work mode: Hybrid

Company Overview

Arcondis is a global consulting company with an exclusive focus on the healthcare and life science industries. Headquartered in Basel, Switzerland, the company has a global footprint with offices in North America, APAC and across Europe. We have been managing challenges and solving problems for our clients in compliance, business processes, information technology, and digital transformation since 2001. Our focus lies in creating value through cross-functional, sophisticated delivery methodologies and intelligent implementation. Our clients love to work with us because of our unique skillsets, our pragmatic approach, and our will to win.

We are a medium-sized international consulting firm dedicated to Life Sciences, with a unique and inspiring culture. Our distinctive culture is the driving force behind our success; it is deeply rooted in our purpose and behaviours. We are owned by a charitable Foundation; our key differentiator is that we contribute to social causes every year. This ethos is not just a part of our identity; it is our way of life. Our motto, \“We make healthcare better,\“ reflects the unwavering commitment we have to improving the lives of people through the work we do.

Our culture fosters collaboration, innovation, and a sense of community that sets us apart from the rest. We are living our values every day. Our leadership is expected to lead by example, demonstrating a dedication to our mission and values.

We embrace diversity and inclusiveness, and we believe in giving back to the community. Together, we are not just consultants; we are agents of change, and our culture is the driving force behind our shared purpose.

About the role

Arcondis is seeking an experienced Process Engineer to design and implement a new manufacturing process pipeline for a sterile drug product, covering the full path from raw materials to the final product. This role requires developing the process from scratch, leveraging existing equipment and facilities while adapting them to meet the specific requirements of new product.

The candidate will collaborate closely with development teams, interpret input data, and transform it into a fully operational process design. The role involves approximately 70% on-site work at the manufacturing facilities and 30% remote work.

Responsibilities

New Product Pipeline Design:

• Design and develop a complete sterile manufacturing process pipeline for a new drug product, from raw substances to the final product.
• Build up the process from the ground, based on development data, ensuring scalability, technical feasibility, and compliance with sterile manufacturing standards.
• Adapt and optimize existing equipment and facilities to meet the specific process requirements.
• Collaborate closely with the process development organization to align on design approach with general requirements.
• Ensure full adherence to engineering principles, quality standards, and validation requirements.

Process Risk/Gaps Identification & Minimization:

• Support internal process evaluations and validation activities to identify and assess further process risks and gaps.
• Contribute to strategic planning and effective execution of risk mitigation and continuous improvement measures.

Qualifications and Experience

• Degree in Process Engineering, Chemical Engineering, or a related field.
• Proven experience in manufacturing process design, engineering, control and validation within pharmaceutical or biotechnology industries.
• Strong technical expertise in process engineering, process optimization, and pipeline design for sterile manufacturing environment.
• Proven ability to identify and control Critical Process Parameters (CPP) to ensure the Critical Quality Attributes (CQA) of the final product.
• Demonstrated capability to recalculate, adjust, and scale up the process requirements from development to manufacturing, considering factors such as equipment size, geometry, and functionality.
• Excellent analytical and problem-solving skills, with experience in risk assessment and mitigation strategy development.
• Experience in developing visualization tools to support risk and performance analysis.
• Strong communication and collaboration skills, with the ability to work effectively in cross-functional and multicultural teams.
• Highly self-driven, organized, and able to work independently with minimal supervision.
• Fluent in German and English, both written and spoken.