摘要
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.
About the Role
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.
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.
Novartis Compensation and Benefit Summary:
The salary for this position is expected to range between $114,100 and $211,900/year. The final salary offered is determined based on factors like, but not limited to, relevant skills and experience, and upon joining Novartis will be reviewed periodically. Novartis may change the published salary range based on company and market factors. 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.
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EEO Statement:
The Novartis Group of Companies are Equal Opportunity Employers. We do not discriminate in recruitment, hiring, training, promotion or other employment practices for reasons of race, color, religion, sex, national origin, age, sexual orientation, gender identity or expression, marital or veteran status, disability, or any other legally protected status.
Accessibility & Reasonable Accommodations
The Novartis Group of Companies are committed to working with and providing reasonable accommodation to individuals with disabilities. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application process, or to perform the essential functions of a position, please send an e-mail to [email protected] or call +1(877)395-2339 and let us know the nature of your request and your contact information. Please include the job requisition number in your message.