Automation Engineering Manager
2 weeks ago
We are seeking an experienced Automation Engineering Manager to join our team at J&J Family of Companies. The successful candidate will be responsible for leading the development and implementation of automation systems, ensuring compliance with global standards and industry best practices.
Key Responsibilities:
- Develop and implement automation systems, including configuration of interfaces and validation protocols.
- Ensure compliance with global standards, including cGMP regulations and industry best practices.
- Lead the CSV team to deliver on key projects and lifecycle management.
- Define Computerized Systems Validation scope and ensure resources, capabilities, and processes are in place.
- Collaborate with Quality, IT, Lab Systems, and Procurement teams to optimize processes.
Requirements:
- BS degree in Engineering, Science, or related discipline.
- Minimum of 6 years of experience in a manufacturing environment, preferably in the biopharmaceutical or pharmaceutical industry.
- Proven experience in an Execution Systems, Automation, or IT role within a pharmaceutical or GMP-regulated manufacturing environment.
- Expertise in ISA S95 and S88 standards and their application within the Global Supply Chain.
- Knowledge of cGMP regulations related to Computer System Validation (CSV), including 21 CFR Part 11 and EU GMP Annex 11.
Preferred Qualifications:
- Experience in supervision/management of people and resources.
- Process knowledge for Upstream, Downstream, and Bio Processing Support functions.
- Proven understanding of GAMP 5 and other recognized industry standard methodologies.
What We Offer:
- Competitive salary and benefits package.
- Opportunities for professional growth and development.
- Collaborative and dynamic work environment.
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