We are seeking an experienced Process Engineer for an exciting opportunity with our client, a biotech company within the Antibody Drug Conjugates (ADC) space. This is an essential role focusing on the qualification of equipment, facility design, and ongoing support for the team as they work to establish and optimize the production process.
Key Responsibilities:
* Qualification of equipment including isolators, single-use reactors, UF/DF systems, purification skids, and buffer preparation vessels
* Support the design and layout of new facilities
* Equipment acquisition and management of supplier relationships
* Leading maintenance and calibration teams
* Troubleshooting and preventive maintenance to ensure equipment uptime and optimal performance
* Ensuring all activities comply with relevant regulations and quality standards
* Support the overall commissioning, qualification, and validation (CQV) processes
* Over 5 years of experience in ADC engineering or related roles
* Expertise with single-use reactors, ultra-filtration & purification techniques
* Experience handling cytotoxic powders and working in high-containment environments
* Strong background in the qualification and validation of equipment (CQV)
* Strong technical understanding of ADC manufacturing processes
* Ability to work independently and collaborate effectively with teams
* Open to occasional travel to the US (Fluency in English is required)
* German language skills are advantageous
Seniority level
Mid-Senior level
Employment type
Contract
Job function
Pharmaceutical Manufacturing
#J-18808-Ljbffr