[jsfg_cinti] Automation Validation Engineer = indianapolis

      Job Title Automation Validation Engineer 
      Job ID: 150 
      Company: Alan N. Daum & Associates, Inc. 
      Location: Indianapolis, Indiana USA 
      Salary: $50000 - 75000 
      Industry:  
      Function:  
      Name:  
      Phone:  
      Fax:  
      Email: alan@xxxxxxxxx
     
      Description:   
      In this Automation Validation Engineer position, you will be responsible 
for computer system validation in one of several departments: Development, 
Parenteral Manufacturing (injectable products), Dry Manufacturing (capsules, 
tablets, ointments), and Bulk Operations (active ingredient). The validation 
coordinator is responsible for supporting automation engineers in their 
computer systems quality and validation efforts for customers in the early 
phase process development area Validation support includes: ·Leadership of 
systems quality and validation activities ·Review and approval of validation 
documents ·Timing and coordination of validation activities to meet overall 
project and production timelines ·Developing processes for improving validation 
compliance and effectiveness Work within this assignment requires collaborative 
effort with other process control team members, training associates, quality 
associates, and management. Job Responsibilities: 1.Support Business 
Processes/Systems Work closely with automation engineers and be responsible for 
understanding and maintaining systems validation through appropriate 
documentation and qualification activities. Develop a thorough understanding of 
computer system validation as applies to process automation systems. Act as a 
focal point for departmental activities around validation. Assure SOP and 
policy compliance throughout the validation process. Knowledge of corporate 
systems quality policies and procedures, and the corresponding local procedures 
is key in this activity. 2. Improve Business Processes/Systems Responsible for 
optimizing the operations through business process improvements. Primary focus 
will be on understanding automation engineering processes and procedures and 
developing means of improving them in compliance with applicable regulations, 
policies and procedures. Understanding and use of metrics as a means of 
tracking progress a plus. 3. Documentation Maintaining or improving validated 
states of process control systems is critical while working in a dynamic 
process development environment. This position will be responsible for managing 
documentation for the area in compliance with the corporate Computer Systems 
Validation Policy, cGMPs, Electronic Records/Signatures, etc. This includes 
scheduling system periodic reviews and assuring delivery of validation 
documentation for projects and maintenance activities. 4. Project Delivery 
Production equipment changes or new installations will require delivery of a 
validated control system for the first product campaign or development 
activities. The validation coordinator plays a key role in assuring the 
automation engineer completes the necessary activities in the proper sequence. 
Participate in the design and development of system documentation. Ability to 
manage multiple activities and keep to project timelines is required.  
      Requirements:   
      ·Bachelors in Engineering or Science with relevant work experience in 
automation validation compliance. ·Knowledge of cGMP validation requirements. 
·Background in process automation. ·Excellent technical writing skills.  


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