Automation Engineer – IT/Lab Equipment – Regeneron Cell Medicines
| Company | Regeneron Pharmaceuticals |
|---|---|
| Location | Cambridge, MA, USA |
| Salary | $79100 – $129100 |
| Type | Full-Time |
| Degrees | Bachelor’s |
| Experience Level | Mid Level |
Requirements
- Bachelor’s degree in Information Technology or related field
- 3-5 years of relevant experience in a manufacturing/lab/IT setting
- Experience in a pharmaceutical or biopharmaceutical manufacturing facility
- Experience with automated systems for environmental monitoring and compliance
- Experience working in a GMP environment is very advantageous
Responsibilities
- Supporting all manufacturing and QC equipment within RCM’s 30,000 SF Phase 1 clinical manufacturing facility
- Maintaining System documentation, including converting User Requirement Specifications to a Detail Design Specification, writing Configuration Test Plans, and summary reports
- Leading IT Applications systems security access and periodic audit trail reviews
- Performing investigations relating to manufacturing deviations and anomalies associated with automation systems and control system software
- Support engineering and validation projects as well as provide support to manufacturing activities with process control and process monitoring equipment software design, commissioning, and testing to meet end user requirements
- Supporting automation activities by updating/authoring system specifications, user and functional requirements specifications, as well as generating and implementing necessary FAT and SAT protocols
- Designing and developing test plans and implementing software/hardware improvements to automated process control and process monitoring equipment according to change control procedures
- Ensuring systems’ data is backed up / archived as required to ensure system can meet defined RTO and RPO; perform recovery of data as needed
- Creating and maintaining configuration specifications for cGMP software for process control, monitoring and testing
- Ensuring systems remain in compliant state including process change control requests for system configurations, including requirement and/or design specifications, test plans, technical evaluation and quality risk assessments
- Supporting system integration with existing systems (ex. LIMS, Historian) as required by business needs
Preferred Qualifications
- Enjoy working in a fast-paced environment and can be flexible with changing priorities
- Thrive in a team-based, multi-functional, collaborative environment
- Possess a problem-solving mentality
- Have excellent verbal and written communication skills