Gilead Sciences is currently seeking an Associate Director of Manufacturing and Maintenance Engineering for our brand new Aseptic Commercial Manufacturing facility in La Verne, CA.
- Manages internal engineering and maintenance processes, and provides support to other groups.
- Oversees the equipment, facilities and utilities maintenance program, and drives innovation to remain current.
- Leads the design, implementation, monitoring and control and closure stages of principle/major department and capital projects for the facility.
- Leads and actively participates in client interface in regards to equipment, facility, and utility lifecycle.
- Oversees and develops the facility long-term capital investment plan and departmental operating budget.
- Cultivates an efficient, professional and safe working atmosphere, and ensure timely results are achieved.
- Ensures timely completion and compliance with cGMP and all other relevant company training requirements.
- Attracts, develops, and retains a high performing team to meet the current and evolving needs of the business through effective selection, training and development, coaching and mentoring and performance management.
- Responsible for overseeing the engineering change control process, preventive maintenance system, receipt and qualification of new equipment, calibration activities, Maximo scheduling system, maintenance of the critical spare parts inventory and facilities related projects.
- Manages project and qualification engineers, calibration techs and technicians needed to conduct projects involving production equipment and the facilities as well as maintaining critical equipment in calibration.
- Oversees any third party engineering firms or projects to deliver results on time and on schedule.
- Serves as business owner of the Maximo PM/Calibration tracking and scheduling system
- Establishes and manages lifecycle programs for production and laboratory equipment
- Serves as the facilities representative on the deviation and change control boards.
- Supervises and coordinates activities for engineers, project managers and calibration techs responsible for all facility and equipment engineering projects. Manages the calibration team to ensure maintenance of all equipment calibrations within required time limits.
- Manage personnel, to include organizing and prioritizing group tasks, performing training, and writing performance reviews. Reviews and approves training matrices.
- Perform a wide variety of activities to support operations.
- Develop, implement, and maintain programs and processes to ensure high quality of operations, and compliance with UBC, UFC, NEC codes, current Good Manufacturing Practices (GMPs) and Good Laboratory and Engineering Practices (GLPs)&(GEP’s)
- Work directly with operating entities to ensure that systems and equipment maintenance, safety inspections, analyses and audits are conducted on a continuing basis as specified to enforce requirements and meet specifications.
- Interface with contractors to establish relationships for Manufacturing, Development, and property administration oversight and inter-company effective communication to address documentation and compliance issues.
- May interface with regulatory agencies as required.
- May write and/or implement changes to controlled documents as needed.
- Develops budgets and monitors expenditures.
- Serves as a role model for strong people and project leadership skills through actions, decisions and directing others.
- Serves as the main point of contact for cross-functional integration and consults on enhancements or future integrations.
- Acts as an escalation point for non-routine function issues/decisions.
- Directs the development of strategic functional programs/initiatives/systems, and determines metrics for program success, and evaluates performance against metrics.
- Analyzes industry trends and anticipates changes in the competitive and regulatory landscapes to adjust plans as appropriate.
- Serves as engineering representative in strategic planning and operating discussions with senior leadership.
- Operations Management, Strategic Management, Manufacturing Management training/knowledge
- Advanced leadership skills
- Budget analysis
- Project management including process improvements such as Six Sigma/Kaizen
- Manufacturing, Engineering Services, Quality, Materials, Technical Services, Validation
Skills and Background required:
- 12+ years of relevant experience and a BS in an engineering field.
- 10+ years of relevant experience and a MA or MBA.
- 8+ years of relevant experience and a PhD.
- Demonstrates deep knowledge and experience in engineering in highly regulated manufacturing environments.
- Has Commercial experience in the BioPharma industry.
- Demonstrates successful experience managing People Managers and small teams.
- Has previous experience in biotech or pharmaceuticals industry.
- Understanding of industry engineering standards for GMP manufacturing and support equipment as well as effective preventive and predictive maintenance practices
- Ability to read and utilize engineering drawings, specification documents and equipment manuals
- Knowledge of cGMPs as defined in FDA CFRs
- Must possess excellent communication (oral and written), organizational, and interpersonal skills, with the ability to perform in a team environment.
- Strong problem-solving skills
- Self-Starter with the ability to operate with a minimum of direction
- Solid basic computer skills