Manager, Process Maintenance
Bora Pharmaceuticals
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).
Job description
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
- 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 parts and effective communication between team members and to E F&V management.
- Lead tier meetings and demonstrate skills related to priority management, and conflict resolution.
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
- 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 pharmaceutical industry guidelines such as ISPE Baseline Guides, ISO and ASME BPE
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
- Isolator fill line experience desired
- Strong oral, written, and listening communication skills
- Proficient with Microsoft Office tools and applicable ERP system
- 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
Benefits
- Competitive salary
- Performance-based incentives
- Medical, Dental & Vision
- Retirement savings plans
- Employer matching contributions
- Paid time off
- Professional development opportunities
- Employee wellness programs
- Employee Assistance Program
- Mental Health Resources
Company overview
Bora Pharmaceuticals is a premier international contract development and manufacturing organization (CDMO) headquartered in Taipei, Taiwan, with a global presence across North America and Asia. Founded in 2007 by Bobby Sheng, the company operates ten state-of-the-art CGMP manufacturing facilities strategically located to serve over 100 markets worldwide. Bora specializes in comprehensive pharmaceutical development and manufacturing solutions for a wide range of dosage forms including oral solid dose, liquids, semi-solids, ophthalmics, biologics, and sterile injectables. The company employs a distinctive dual-engine strategy that combines scalable CDMO services with innovative drug development focused on specialty pharmaceuticals and rare diseases. With a workforce of 1,001-5,000 employees, Bora provides end-to-end services from early phase clinical development through commercial manufacturing, supported by full packaging capabilities. The company is publicly traded on the Taiwan Stock Exchange (TWSE: 6472) and has established itself as a trusted partner for biopharmaceutical companies globally through its commitment to quality, operational excellence, and strategic growth initiatives.