Computer System Validation Specialist

2 weeks ago


West Point, United States AA2IT Full time
Job DescriptionJob Description

Location: 770 Sumneytown Pike, West Point, PA
Must Have: 
Need someone who is pro-active, troubleshoot
Experience | Skills | Knowledge Required
• 3+ years in process automation or equivalent in pharmaceutical/ biotechnology industry.
• Familiarly with Computer system validation and regulatory GXP requirements.
• Knowledgeable of S88 Batch Standard
• Technical and operational expertise in automation control systems such as Emerson DeltaV, AB PLC, Factory talk, SCADA, Windows operating systems, network infrastructure, SQL, etc.

Education- Bachelors preferred but Associates acceptable (with good experience).
Required-
3+ years in process automation or equivalent in pharmaceutical/ biotechnology industry.
• Familiarly with Computer system validation and regulatory GXP requirements.
• Knowledgeable of S88 Batch Standard
• Strong communication and interpersonal skills to interface effectively with all levels of colleagues in a team environment, and with external parties.
• Technical and operational expertise in automation control systems such as Emerson DeltaV, AB PLC, Factory talk, SCADA, Windows operating systems, network infrastructure, SQL, etc.

Responsibilities:

This role is to provide automation support to our vaccine manufacturing facility.
Responsible for problem resolution, implementation of process control, data collection techniques, and troubleshooting in compliance with SDLC, GMP, safety, and environmental regulations.
Actively support, participate and embrace a diverse and inclusive culture including significant interaction with manufacturing, quality and engineering groups. Supports a broad spectrum of automated systems within GMP Manufacturing Operations.

Key Functions
• Comply with Global Policies, Procedures and Guidelines, regulatory requirements and execute current Good Manufacturing Practices (cGMP) in the performance of day-to-day activities and all applicable job functions.
• Provide automation system support and expertise to assist the manufacture of quality vaccine products to meet site priorities.
• Responsible and accountable for supporting all automation system components of the processes including on the shop floor support of manufacturing activities
• Responsible for designing, implementing, testing, and closing-out change controls for automation related corrective actions and continuous improvement initiatives.
• Participate in investigations of automation incidents and problems to prevent recurrence including the development and implementation of corrective actions.
• May require to provide off-site weekend/evening automation phone or on-site support as needed.
 

Company DescriptionAA2IT is in this business to make you successful. Strategy, Execution and Value. There are too many businesses that have solid, well-thought-out strategies that sit in a drawer somewhere collecting dust. Executing on Strategy effectively and measuring what matters drives the value. We start with your business strategy, align technology strategy, and create a roadmap that gets your business value.

AA2IT is a global firm providing Staffing and IT Solutions. We are headquartered in Texas, delivering successful talent acquisition and technology services. We are fully digital organization with a people centric and a technology driven vision.Company DescriptionAA2IT is in this business to make you successful. Strategy, Execution and Value. There are too many businesses that have solid, well-thought-out strategies that sit in a drawer somewhere collecting dust. Executing on Strategy effectively and measuring what matters drives the value. We start with your business strategy, align technology strategy, and create a roadmap that gets your business value.\r
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AA2IT is a global firm providing Staffing and IT Solutions. We are headquartered in Texas, delivering successful talent acquisition and technology services. We are fully digital organization with a people centric and a technology driven vision.

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