Senior Automation Engineer
4 weeks ago
Job Summary
Catalent Inc is seeking a highly skilled Senior Automation Engineer to join our team. As a key member of our Automation Engineering Department, you will be responsible for designing, implementing, and maintaining automation systems that support our manufacturing processes.
Key Responsibilities
- Administer process control systems, digital control systems, and equipment-specific systems.
- Monitor, maintain, and repair existing production and laboratory control and monitoring systems.
- Server management, disaster recovery, system backups, data management, and secure analytical data results.
- Create computerized equipment configuration, set up, procedures and training, equipment and control system troubleshooting and repair.
- Work with process engineers or facility technicians to ensure equipment is running in an automated fashion, making improvements to automated unit operations to minimize user interaction and add consistency to production/product safety.
- Act as primary Subject Matter Expert (SME) for CSV and alignment with corporate IT policies and working with Validation, assist in drafting, reviewing, executing, and approving protocols and reports related to Automation/Computer System Validation (CSV).
- Author and/or participate in investigations related to deviations and deviation management caused by automated system failures.
- Assist in responding to customer/regulatory audit observations and corrective actions as it pertains to automation system validation.
- Author system administrative procedures to ensure all aspects of system management contains defined management steps and sufficient detail to ensure consistent implementation.
- Create and support site Automation Vision / Roadmap to keep Catalent competitive with peers to be Partner of Choice for external customer business and Continue Automation / Digitization Roadmap for site Vision and Strategy of Automation Projects and Improvements.
Requirements
- Minimum Bachelor's degree in Engineering or related scientific field with a minimum 8+ years' experience with facility network, architecture, and integration in a cGMP environment (preferably biopharmaceutical) implementing GAMP/Part 11 compliant systems.
- Project management experience, preferred.
- Proficient in Excel, Word, and other office systems.
- Skilled in creating complex reports and delivering presentations, with the ability to cross-train across various groups.
- Capable of independently interpreting data, analyzing trends, and completing investigation, deviation, and change control forms.
- Experienced in operating and troubleshooting various instrumentation and data systems (e.g., PCS, DeltaV, Allen/Bradley, PLC).
- Ability to introduce new technologies, drive process improvements, and collaborate with teams to develop and transfer methods.
- Strong understanding and adherence to regulatory guidelines and standards.
About Catalent
Catalent is a global leader in the development and manufacture of products for the healthcare industry. We are committed to helping our customers bring new medicines to market quickly and efficiently, while ensuring the highest quality and safety standards.
Why Work at Catalent
- Defined career path and annual performance review and feedback process.
- Diverse, inclusive culture.
- Potential for career growth on an expanding team within an organization dedicated to preserving and bettering lives.
- 152 hours of paid time off annually + 8 paid holidays.
- Competitive salary with yearly bonus potential.
- Community engagement and green initiatives.
- Generous 401K match and Paid Time Off accrual.
- Medical, dental and vision benefits effective day one of employment.
- Tuition Reimbursement.
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