Manufacturing Systems Engineer - II (Associate)

Education Minimum Requirement:

• Bachelor's Degree in Engineering or Science plus a minimum of 2 years’ experience in the Pharma industry.
  
  

Required Experience and Skills:

• Knowledge of computer validation processes.
• Familiarity with working in a cGxP environment.
• Effective organizational skills.
• Effective communication
• Strong computer skills.
• Able to work independently
  
  

Preferred Experience and Skills:

• Kneat - Paperless electronic validation system
• The candidate should be able to work independently and lead or facilitate tasks successfully.
  
  

Notes:

• Onsite role @West Point site.
• This role requires you to move around the labs, looking at the labs systems, inspecting the system and equipment in the labs. Setting up meeting with owner of lab system. Analyze information and create or write reports. You will need to walk down to the entire labs and inspect the lab systems and equipment.
  
  

Must haves:

• Knowledge of computer validation processes.
• Knowledge of software development lifecycle (“SDLC”).
• Experience working within GMP or in a regulated environment
• Familiarity with manufacturing equipment and systems is a plus.
• Technical writing skills.
• Computer skills.
  
  

Responsibilities:

This role will require routine interaction with business areas across the West Point site.

The candidate will primarily perform computer system periodic reviews for laboratory systems and manufacturing equipment periodic reviews.

There is also the potential to support the implementation of a new computerized maintenance system through the review and evaluation of maintenance master data.

• Manage the periodic review schedule and generate reports.
• Identification and review of system procedures; ensuring these procedures are being utilized to perform system backups and security reviews
• Review of software development lifecycle (“SDLC”) documentation to ensure compliance with *** procedures.
• Review of events / logs / issues identified for the system during the review period to ensure system performance.
• Confirmation and review of calibration/maintenance actions for the system
• Perform a review/evaluation of completed change records
• Perform an analysis of all information/data collected and generate a report to summarize any findings and conclusions.