Senior Manager Asset Lifecycle Management

Novartis • Durham, CA

6d

About The Position

The Senior Manager, Engineering – Asset Lifecycle Management, leads a team of site-based engineers to establish, maintain and improve asset reliability for all process and lab equipment. Overall accountability for the reliable operation, integration, modification, maintenance, and retirement of site process equipment. The initial focus of this role will be to support the design, build, and qualification of a new facility to manufacture large molecule drug substance. Following completion of the project, the role will transition to operational support and lifecycle management of the process equipment.

Requirements

• Bachelor of Science degree in Engineering or other relevant degree with 9 years of experience across process engineering, maintenance, qualification, and continuous improvement for process equipment in biotechnology operations.
• Industry expertise in the design, reliable operation, modification, maintenance, and retirement of production equipment.
• Demonstrated ability to work and collaborate on cross functional teams (QE, QA, validation, operations) in a fast paced, dynamic team setting.
• Strong interpersonal and excellent verbal and written communication skills are essential.
• Knowledgeable of health, safety and environmental regulations, and FDA (and similar) cGMPs.
• Planning, problem analysis, and decision-making skills.
• Proficient computer skill utilizing MS Office suite applications, Building Management Systems, and Computerized Maintenance Management Systems (CMMS).
• Self-motivated with a strong sense of ownership in areas of responsibility.

Responsibilities

• Defines and continuously improves the site maintenance strategy for process, utility, QC, and TRD equipment.
• Executes asset strategy and proper lifecycle asset management to global Novartis standards.
• Manages the site reliability program and pushes a data driven model to ensure the availability, reliability, and validated state of assets.
• Manages engineers supporting 24/7 operations providing clear, consistent leadership, management and mentoring.
• Ownership of all master data for site process, utility, QC, and TRD equipment.
• Develops, monitors and improves KPI’s for system reliability
• Recapitalization planning for critical assets.
• Change management and CAPA ownership to drive continuous equipment reliability on process equipment.
• Leads SME’s for deviation investigations involving equipment.
• Leads SME’s for process and QC equipment in regulatory audits.
• Ensures training curriculum is optimized and ensure cross training of individuals across the group.
• Support site capital projects by creating equipment specifications in standard documentation – User Requirements (URS), Functional Specification (FS) and Detail Design Specifications (DDS), etc.
• Work closely with operations and manufacturing sciences to evaluate new product introductions and facility fit evaluations.
• Lead small teams to define and advance facility and equipment changes in line with 5- and 10-year strategic plans.
• Support development of site facility and equipment master plans, network business processes associated with asset lifecycle, and GTx Engineering initiatives or programs.
• Other related job duties as assigned.

Benefits

• Your compensation will include a performance-based cash incentive and, depending on the level of the role, eligibility to be considered for annual equity awards.
• US-based eligible employees will receive a comprehensive benefits package that includes health, life and disability benefits, a 401(k) with company contribution and match, and a variety of other benefits.
• In addition, employees are eligible for a generous time off package including vacation, personal days, holidays and other leaves.

What This Job Offers

• Job Type: Full-time
• Career Level: Senior
• Number of Employees: 5,001-10,000 employees