Manager, Process Maintenance

Bora Pharmaceuticals•Baltimore, MD

5d•Onsite

About The Position

Bora Bora Pharmaceuticals is a premier international contract development and manufacturing organization (CDMO) specializing in formulation development, clinical and commercial manufacturing, and packaging of complex oral solid dose, liquid, semi-solid, biologics, and sterile injectable pharmaceutical products. From our world-class sites in North America and Asia, we deliver drug products with unparalleled quality to more than 100 markets around the world. Bora’s teams, technologies, and facilities work seamlessly together to enable our clients to deliver much-needed therapeutics to patients worldwide. At Bora Pharmaceuticals, we see it as our mission, our duty, our responsibility, to make our success and our customer’s success more certain.

Requirements

Bachelor of Science degree in Engineering
Eight plus years of experience in a pharmaceutical/process industry setting
Detailed engineering knowledge of process equipment design, operation and repair
Knowledge of 3D drawing and CNC machining
Strong oral, written, and listening communication skills
Proficient with Microsoft Office tools and applicable ERP system

Nice To Haves

Isolator fill line experience desired
Working knowledge of SAP
Working knowledge of Operational Excellence / Lean Manufacturing
Familiarity with FDA regulations relating to biologic and drug products
Familiarity with FDA current Good Manufacturing Practices
Familiar with pharmaceutical industry guidelines such as ISPE Baseline Guides, ISO and ASME BPE

Responsibilities

Provide leadership and supervision for the activities of the equipment specialist team.
Exemplify strong and effective communication including providing constructive and goals-based feedback, and employee tailored personnel development.
Motivate and empower direct/indirect reports to ensure the safe and effective acquisition/use/maintenance of all production equipment.
Propose and orchestrate continuous improvement projects on manufacturing equipment to ensure equipment uptime is maximized and obsolete components are upgraded where possible.
Procure, coordinate the qualification of, and manage equipment and engineering vendors
Propose and lead capital project execution as required on process improvements
Orchestrate fit tests, machinability and engineering runs as required.
Ensure preventive maintenance program is executed and improved as needed on manufacturing equipment.
Provide technical support and troubleshooting assistance to manufacturing personnel on technical issues that are beyond the training or experience of that organization
Plan and lead shutdown preventative maintenance and project tasks on all production and packaging equipment.
Ensure 6S of spare
Ensure communication is effective between team members as well as communication being effective to E F&V management.
Lead tier meetings and demonstrate skills related to priority management, and conflict resolution