Manager, Process Maintenance

About 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.

Job Summary

Lead production and packaging equipment maintenance and reliability program at the Camden campus. Lead team of Equipment Specialists to ensure equipment uptime as well as complete engineering level projects to continuously improve equipment reliability. Heavy focus on personnel/team development as it pertains to repair and troubleshooting current and future manufacturing equipment, performance management, and client/regulatory facing (process equipment/systems operation).

Essential Functions

Reasonable accommodations will be made to enable individuals with disabilities to perform the essential functions.

• 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

The above statements are intended to describe the nature of work performed by those in this job and are not an exhaustive list of all duties. Nothing in this job description restricts managements right to assign or reassign duties and responsibilities to this job at any time which reflects management's assignment of essential functions.

Minimum Education, Experience and Skills

• 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
• Isolator fill line experience desired
• Strong oral, written, and listening communication skills
• Proficient with Microsoft Office tools and applicable ERP system

Skills:

• Demonstrated ability to:
• - provide clear direction and motivate teams
• - lead by example through strong work ethics and high standards
• - be hands-on and available during off-hours
• - work as a team leader or as a team member
• - influence other individuals and departments
• - adapt quickly to changing priorities
• - continue to improve skills through professional development

Advanced Requirements:

• 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…