Process Engineer II/III – Manufacturing Technical Operations, Downstream

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 into a first-of-its-kind flexible and reconfigurable cGMP manufacturing facility. The selected candidate will be responsible to work with process development to develop product 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 and troubleshooting for CAPA and NC closeout 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.

Position Requirements:

• 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
• Understanding of chromatography and filtration processing equipment and operations used to manufacture biotherapeutics
• Proven knowledge of cGMP requirements and experience writing manufacturing batch records, standard operating procedures and technical documents
• 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
• 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:

• 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