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 process transfer for clinical and commercial biologics into a first-of-its-kind flexible and reconfigurable cGMP manufacturing facility
The selected candidate will be responsible for working with process development to develop process transfer documents and support the development of manufacturing batch records and operating procedures for the process. In addition, the candidate will be responsible for supporting the commissioning and validation of new process equipment in the facility, supporting process engineering activities, including writing technical documentation within cGMP compliant systems, troubleshooting equipment, and introducing new manufacturing technologies such as continuous processing. The staff member may also provide person-in-plant support to partners, assist in generation of relevant regulatory submissions, provide support for regulatory and site inspections, and provide input to department capital and expense budgets.
- Bachelor’s degree in engineering science or related program with 5+ years relevant experience.
- Significant experience leading process transfer / technology transfer projects and teams in the biopharmaceutical industry; commercial manufacturing campaign support is a plus
- Familiar with process risk assessment tools (e.g., FMEA) developing process models, and process trending.
- Solid understanding of upstream processing including single-use bioreactor operations and perfusion technology.
- Hands on experience of upstream 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
- Ability to organize, analyze/interpret, and effectively communicate process data
- Good interpersonal, team, and collaborative skills are a must
- Excellent oral and written communication skills
Additional Preferred Qualifications:
- Recognized technical mastery of upstream disposable manufacturing technologies from bench-scale through commercial scale.
- 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 equipment commissioning/validation activities
- Experience with DeltaV for process control
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.