Associate Specialist , Manufacturing Automation

** Job Description
** The Manufacturing Automation Associate Specialist position shall support a GMP testing laboratory at a manufacturing facility for sterile vaccine products. Responsibilities include supporting computer system validation, implementing process control and data collection, and troubleshooting in compliance with SDLC, cGMP, safety, and environmental regulations. The Manufacturing Automation Associate Specialist must actively support, participate, and embrace an empowered team culture including significant interaction with manufacturing, quality, IT, and engineering groups.  

This role supports a large spectrum of sophisticated automated systems within Laboratory Operations, providing multiple opportunities to learn new automation technologies and make a positive impact.
** Primary activities include, but are not limited to:
*** Performs routine assignments in the entry level of a professional role
* Learns and supports all Good Manufacturing Practices (GMPs), safety, and environmental regulations.  Review automation documents, preventive maintenance, and SOPs to ensure compliance with Good Manufacturing Practices and safety.
* Technical leadership for the assigned area and system(s) to ensure a compliant, reliable supply of product and on time project execution and system delivery.
* Provide technical guidance/support including authoring or review of system qualification documents, change control, Quality Notifications (QNs), and other key automation related processes
* Participates in audits and training programs in the area of responsibility.
* Participates in investigations of automation incidents and problems to prevent recurrence including the development and implementation of corrective actions.
* Evaluates automated and information technology systems and develops strategies to optimize and ensure quality and stability of automation systems through process improvement, future expansion, replacement, or upgrade.
* Initiate and lead collaboration within the Operations, Quality and Technical organizations to resolve complex problems.
* On-floor support of manufacturing/laboratory activities.
** Education Minimum Requirement:
*** B.S., B.A., or greater preferably in Engineering, Science, or Information Technology
** Preferred

Experience and Skills:

*** Experience in PLCs, SCADA, laboratory equipment, and/or PI.
*
* Required Skills:

** Accountability, Audit Management, Business Process Improvements, Collection Processes, Communication, Corrective Action Management, Data Collection Methods, Data Management, Environmental Health And Safety, Environmental Regulations, GMP Compliance, Good Manufacturing Practices (GMP), Laboratory Automation, Leadership, Manufacturing, Problem Management, Quality Management, Real-Time Programming, SCADA Control Systems, Software Development Life Cycle (SDLC), System Validation, Technical Leadership
** Preferred

Skills:

** Current Employees apply

Current Contingent Workers apply
** US and Puerto Rico Residents Only:
** Our company is committed to inclusion, ensuring that candidates can engage in a hiring process that exhibits their true capabilities. Please  if you need an accommodation during the application or hiring process.

As an Equal Employment Opportunity Employer, we provide equal opportunities to all employees and applicants for employment and prohibit discrimination on the basis of race, color, age, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability status, or other applicable legally protected characteristics.  As a federal contractor, we comply with all affirmative action requirements for protected veterans and individuals with disabilities.  

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