Lead Automation Engineer
3 weeks ago
Position Overview
The Lead Automation Engineer plays a crucial role in overseeing automation systems, interfaces, and equipment within the organization. This position is responsible for the management of automation systems throughout the facility, ensuring adherence to internal Good Manufacturing Practices (GMP), Computer System Validation (CSV), and external regulatory standards.
Key Responsibilities
- Oversee the management of automation systems, including building management systems (BMS), environmental monitoring systems (EMS), and laboratory equipment automation.
- Develop and implement the automation asset care strategy, encompassing upgrades, maintenance contracts, and system modifications.
- Lead the qualification of automation systems and address any automation-related challenges that arise.
- Update and create User Requirement Specifications, Functional Specifications, and Design Specifications for both new and existing control systems.
- Innovate solutions to complex challenges by adapting standard automation principles.
- Collaborate with various departments, including manufacturing, engineering, and quality assurance, to manage a diverse array of projects.
- Plan, develop, and execute automation projects from inception to completion.
- Establish and maintain a stable automation environment through effective oversight and preventative maintenance.
- Manage project work plans, meetings, deliverables, and progress reports to ensure project success.
- Coordinate training for new users of automation systems.
- Ensure compliance with cGMP and CSV regulations, addressing data integrity issues as necessary.
- Initiate and manage change control activities related to automation systems.
- Act as the system/application owner for automation systems, liaising with IT on infrastructure matters.
- Oversee external resources providing technical support to operations.
- Manage and resolve corrective actions associated with automation systems.
Qualifications
Applicants should possess a Bachelor's degree in engineering, computer science, automation, or a related field, along with a minimum of 7 years of relevant engineering experience in the Chemical or Pharmaceutical industry, or 10 years of equivalent experience in lieu of a degree. Strong communication skills, knowledge of FDA regulations (particularly 21 CFR part 11), and familiarity with pharmaceutical GMP manufacturing operations are essential. Experience in aseptic fill/finish and/or radiopharmacy is preferred, along with training in radiochemistry and radiation safety.
Compensation and Benefits
The anticipated salary range for this position is between $124,000 and $186,000 annually, with variations based on individual factors such as market location and experience. The total compensation package may also include additional elements such as sign-on bonuses, stock options, and a comprehensive benefits package.
Commitment to Diversity & Inclusion
Novartis is dedicated to fostering a diverse and inclusive workplace, ensuring equal opportunity for all individuals. We strive to build teams that reflect the communities we serve and promote an environment that encourages innovation through collaboration.
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