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 maintain and upgrade existing process equipment as well as develop and integrate new upstream processing equipment into a first-of-its-kind flexible and reconfigurable cGMP manufacturing facility
The selected candidate will be responsible for working with process development group to develop process equipment requirements, automation group to develop the process operations and recipes and the validation group to complete equipment commissioning and qualification. In addition, the candidate will be responsible for supporting the development of equipment standard operating procedures, working with the New Product Introduction team on manufacturing batch records and process engineering activities including troubleshooting equipment, closing out deviations, and introducing new manufacturing technologies. 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 1+ years relevant experience.
- Experience in working on equipment design teams in the biopharmaceutical industry; commercial manufacturing equipment design and support is a plus.
- Familiar with process risk assessment tools (e.g., FMEA) developing process models, and process trending.
- 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