A company that develops equipment and cell cultures, is looking for a Senior Bio-Process Engineer to join the R&D team.
Responsible for organizing, running, sustaining, and continuously improving the manufacturing operations process.
This individual will work on the manufacturing floor to produce cell products, troubleshoot equipment and will be responsible for design and manufacturing of equipment.
Directs and develops a team responsible for the optimization, design, and implementation of manufacturing processes and equipment. Drives continuous improvement in process design, cost savings, quality, and resource utilization.
Other responsibilities include managing overall day-to-day manufacturing activities, experiments design and working with other departments on all engineering development to drive continuous improvements.
The Senior Bio-Process Engineer will be responsible for driving the process, good documentation practices, and providing leadership for the team. This individual will participate in the hiring and training of key manufacturing personnel for both upstream cell culture, HW design and manufacturing and filling operations.
Process development that meets the site’s strategic objectives.
cGMP documentation & QC .
Regulation of the manufacturing processes and equipment.
Responsible for maintaining quality standards to meet cGMP requirements, CFR’s, and internal company policies related to the manufacturing process.
Provide hands on technical leadership to the manufacturing staff members.
Required Education and Experience
Ph.D. degree in cell biology / biochemistry / chemical engineering / bioengineering or related technical field.
A minimum of 5-8 years of experience in biopharmaceutical based fermenter / bioreactor - processes in GMP manufacturing operations including experience in cell culture, recovery, purification, aseptic fill/finish with working knowledge of FDA regulations and GMP systems.
Excellent oral and written communication skills. Strong technical writing ability required.
Ability to motivate peers and staff, foster a culture of continuous improvement and operation excellence.
Experience with 3rd parties (equipment vendors, and contract manufacturing insourcing/outsourcing).
Project management skill set with experience in strategic/tactical planning.
* The position is for both men and women
יש לשלוח מייל ולרשום בנושאו JB-47