
Facilities Development Expert
17 hours ago
Job Summary:
As an Executive, you will play a pivotal role in spearheading new facility design and concept development. Your responsibilities will encompass basic and detailed engineering design with a focus on upstream and downstream unit operations.
Key Responsibilities:
- ">
Developing and implementing cutting-edge facility designs and concepts to drive business growth.
">Providing support for the scale-up and technology transfer of 2KL SU and 6 KL SS mAb manufacturing facilities.
">Troubleshooting equipment and process issues in upstream and downstream operations.
">Ensuring knowledge of monoclonal antibody manufacturing processes and supporting production operations.
">Handling CAPEX requirements for multiple drug substance facilities.
">Introducing new technologies and systems into production facilities.
">Providing active support in process and cleaning validation.
">Driving process automation for equipment and recipes phases.
">Investigating process trouble shooting and CAPA identification.
">Conducting technology transfer facility fitment assessments.
">Utilizing software tools like SuperPro SchedulePro and Process simulations.
">Creating process analytics models using SIMCA and other standard analytical tools.
">Qualifying equipment and reviewing FAT and SAT protocols.
">Possessing basic automation knowledge for recipes and Siemens PCS7.
">Complying with EHS policies and cGMP practices as per SOPs.
">Requirements:
- ">
Strong background in engineering design and operations.
">Excellent problem-solving and troubleshooting skills.
">Ability to work effectively in a fast-paced environment.
">Strong communication and interpersonal skills.
">Knowledge of industry standards and regulations.
">What We Offer:
A dynamic and challenging work environment that offers opportunities for professional growth and development.
Competitive compensation and benefits package.
Opportunities for career advancement and professional development.
Collaborative and supportive team environment.
Autonomy to work independently with minimal supervision.
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