Quality Manager ( Automation Engineer)

 
**EASY APPLY on our Company Page with RESUME ONLY (Cover page optional). 



This position is responsible for providing Quality & Compliance oversight to site qualification / validation projects related to installations, changes and upgrades to automated systems.  

This position is responsible for ensuring the site policies and regulatory requirements are followed for computer system commissioning, qualification and validation projects on site.


The individual will participate in project teams and will review and approve computer validation related documentation for automated systems including but not limited to Validation Plans, User Requirements, Specifications, FATs, SATs, IOQs and PQs.


Excellent communication skills and teamwork are a must, as individual will be working with various departments.  Good interpersonal and influencing skills are important for a candidate's success in this role.
This position has signatory responsibilities for all qualifications/validation issues associated with assigned area(s).

Skills: 

Individual should have a minimum of five years' experience in a GMP regulated environment working on validation of automated systems

The successful candidate will have a broad experience and knowledge in the following areas:

  • Knowledge of 21CFR Part 11, Annex 11 and GAMP V
  • Experience in commissioning and Qualification of control systems.
  • Experience with a variety of control systems including DCS, PLCs and SCADA.
  • Experience with HMI SCADA systems such as iFIX, Rockwell RSView and Wonderware.
  • Experience with Batch Systems such as Proficy batch execution and RSBatch.
  • Experience with PLCs such as Rockwell GE Fanuc, Siemens and Modicon

Education: 
Bachelor's degree in Engineering, Computers or related field.  

Required Skills:  
CONTROL SYSTEMS 
EXCELLENT COMMUNICATION SKILLS 
GMP 
HMI 
RSVIEW  
Additional Skills: 
SCADA 
WONDERWARE 
COMPUTER VALIDATION 
DOCUMENTATION 
FANUC 
GE FANUC 
HUMAN MACHINE INTERFACE 
MODICON 
SIEMENS 

About us:

We are not a large corporate consulting conglomerate, we are a small and steadily growing valuable consulting firm. -Valuable to our clients and consultants we work with. We have an excellent reputation with our clients and one that we continue to build upon. We are always looking for top talent.

 
**EASY APPLY on our Company Page with RESUME ONLY (Cover page optional). 

 



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