Manager, Process Maintenance

Bora Pharmaceuticals Injectables•Baltimore, MD

20d

About The Position

The Manager, Process Maintenance leads the production and packaging equipment maintenance and reliability program at Bora Pharmaceuticals’ Camden campus. The role leads a team of Equipment Specialists to maximize equipment uptime and completes engineering-level projects to continuously improve equipment reliability. It places a strong emphasis on team and personnel development, including troubleshooting and repairing current and future manufacturing equipment, performance management, and client- and regulatory-facing operation of process equipment and systems. The manager provides technical support to manufacturing personnel, oversees preventive maintenance and shutdown work, coordinates equipment qualification and engineering vendors, and leads capital and continuous improvement projects. The position also oversees communication and priority management within the team and with E F&V management.

Requirements

Bachelor of Science degree in Engineering.
Eight or more years of experience in a pharmaceutical or 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.
Proficiency with Microsoft Office tools and an applicable ERP system.
Ability to provide clear direction and motivate teams.
Ability to lead by example through strong work ethic and high standards.
Ability to be hands-on and available during off-hours.
Ability to work as a team leader or team member.
Ability to influence individuals and departments.
Ability to adapt quickly to changing priorities.
Commitment to continued skill improvement through professional development.
Working knowledge of SAP.
Working knowledge of Operational Excellence or Lean Manufacturing.
Familiarity with FDA regulations relating to biologic and drug products.
Familiarity with FDA current Good Manufacturing Practices.
Familiarity with pharmaceutical industry guidelines such as ISPE Baseline Guides, ISO, and ASME BPE.

Nice To Haves

Isolator fill line experience.

Responsibilities

Provide leadership and supervision for the Equipment Specialist team.
Communicate effectively, provide constructive and goals-based feedback, and tailor personnel development to employees.
Motivate and empower direct and indirect reports to ensure the safe and effective acquisition, use, and maintenance of production equipment.
Propose and coordinate continuous improvement projects to maximize equipment uptime and upgrade obsolete components where possible.
Procure equipment, coordinate its qualification, and manage engineering vendors.
Propose and lead capital project execution for process improvements as required.
Coordinate fit tests, machinability runs, and engineering runs as required.
Ensure the preventive maintenance program for manufacturing equipment is executed and improved as needed.
Provide technical support and troubleshooting assistance to manufacturing personnel on issues beyond their training or experience.
Plan and lead shutdown preventive maintenance and project tasks for production and packaging equipment.
Ensure 6S of spare [as stated in the posting].
Ensure effective communication among team members and with E F&V management.
Lead tier meetings and demonstrate priority management and conflict resolution skills.