Principal Process Engineer – JPOD Expansion

Just is seeking a highly motivated Process Engineer in the Manufacturing Technical Operations group that desires a significant opportunity to improve worldwide access to biotherapeutics. The primary focus of this job is to lead facility start up activities in our flexible and reconfigurable cGMP manufacturing facilities. The selected candidate will be responsible for supporting the specification of process equipment, factory and site acceptance testing, commissioning, qualification, and validation of new process equipment in the facility, supporting process engineering activities and introducing new manufacturing technologies such as continuous processing. The staff member may also provide support for regulatory and site inspections and provide input to department capital and expense budgets. The successful candidate must be willing to travel.

Position Requirements:

• Bachelor’s degree in engineering science or related program with >10 years relevant experience
• Experience with equipment factory and site acceptance testing, commissioning/validation activities
• Developing data sheets / user requirement’s specifications for process equipment
• Understanding of bioreactor, chromatography and filtration processing equipment and operations used to manufacture biotherapeutics
• Proven knowledge of cGMP requirements.
• Hands on experience with single use flow path operations and disposable-based manufacturing technologies from bench-scale through commercial scale
• Working knowledge of manufacturing process equipment and automation systems
• Candidate must possess strong focus on quality and attention to detail as well as effective task/ time management organizational skills
• Familiar with process risk assessment tools (e.g. FMEA)
• Ability to organize, analyze/interpret, and effectively communicate data
• Good interpersonal, team, and collaborative skills are a must
• Excellent oral and written communication skills
• Develop project plans and performs project management to ensure facility start up activities are performed in a timely manner
• Interact and mentor process engineering staff to ensure effective development of their knowledge and expertise
• Participate as a subject matter expert in facility design reviews
• Ability to build and lead technical teams in a facility start up environment

Additional Preferred Qualifications:

• Applies knowledge to solve complex technical problems; may apply novel approach that provides significant technology advancement
• Can work independently and in project teams; significant contributor to multi-disciplinary teams at the functional level
• Ability to navigate global regulatory CMC documents
• Experience with DeltaV for process control
• Experience with commercial manufacturing campaign support is a plus

About Just – Evotec Biologics

Established in 2014, Just Biotherapeutics, Inc. was acquired by Evotec SE in 2019. Just – Evotec Biologics, is a unique platform company that integrates the design, engineering, development, and manufacture of biologics. With deep experience in the fields of protein, process and manufacturing sciences, the Just team came together to solve the scientific and technical hurdles that block access to life-changing protein therapeutics; from the design of therapeutic molecules to the design of the manufacturing plants used to produce them. Our focus is to create access and value for a global market through scientific and technological innovation.