QA Validation Specialist 3

Notes from intake - Role is Equipment validation and Cleaning Validation Experience with Kneat is absolutely required. Experience with Ellab for Temp Mapping is a plus Manager is looking for candidates with Cleaning Val (CIP, COP, SIP). 95% of equipment is Single Use, so the Cleaning Val is limited mostly to Media Hold/Media ...

Notes from intake - Role is Equipment validation and Cleaning Validation
Experience with Kneat is absolutely required. Experience with Ellab for Temp Mapping is a plus
Manager is looking for candidates with Cleaning Val (CIP, COP, SIP). 95% of equipment is Single Use, so the Cleaning Val is limited mostly to Media Hold/Media Fill. Cleaning Val is mostly Drafting SOPs
Other equipment includes Autoclaves, Parts Washers, and Storage equipment (cold and ambient). Looking for the worker to Build Equipment Requalifications in Kneat.

• 
  
• Provide Subject Matter Expert support to Quality Control, Manufacturing and other departments for the design, operation and troubleshooting of equipment.
• 
  

• 
  
• Drive/own the validation plans and execution of equipment changes and process improvements.
• 
  

• 
  
• Execution of Installation Qualifications/Operational Qualifications and drafting Performance Qualifications as required.
• 
  

• 
  
• P erfo r m E q u i p m e n t V a l i d a t i on a c t i v i t i es t o i n c l u d e V a li d a t i on M a i nt e n a n c e Q u a l i ty S ys t e ms re v i ew a n d r e q u a l i f i c a t i on to e n s ure G MP e q u i p m e n t i s c o n t i n u o u s l y m a i nt a i n e d i n a v a l i d a t ed s t at e .
• 
  

• 
  
• P r o g r a m, or g a n i z e, a nd m a i n t a i n V a l i d a t i o n e q u i p me nt a n d su p p l i es i n c l u d i ng d at a l o g g ers a nd p r o b e s .
• 
  

• 
  
• Dem o n s trate a g e n e r a l u n d er s ta n d i ng of b i o p h ar m a c e ut i c a l m a n u factur i ng e q u i p m e nt a nd v a l i d at i on p r o c e d ures fo r I n s ta l l a t i on V eri f i c a t i on ( I V /IQ ) , Clean-In-Place (CIP), S t e a m- I n - P l a c e (S I P ) , A ut o cl a v e s , C l e a n U t i l i t i e s , S h i p p i ng V a l i d a t i o n, T e m p e r at u r e M a p p i n g C o ntro l l e d S tor a Client R o o ms a n d E q u i p m e n t.
• 
  

• 
  
• De v e l o p va l i d at i on proto c o l s from p l a n s a nd e n g i n e e ri ng d o c u m e nts.
• 
  

• 
  
• P r o v i d e b a s i c t e c h n i c al s u p p o r t w h en re v i ew i ng a n d a p pro v i ng S O P s , P r ot o c o l s , C h a n g e C o ntro l s , Dev i a t i o n s , C AP A , e tc.
• 
  

• 
  
• P erfo r m as s i g n ed Q u a l i ty Sys te m s act i v i t i es w i t h i n D o c u m e n t M a n a g e m e nt S ys tem (D M S ) , T r a ck W i s e Qu a l i ty S ys tem ( C h a n Client C o ntr o l , De v i a t i o n , C A P A )
• 
  
• Perform other duties as assigned.
• 
  

Job Sumary:
Equipment Validation Analyst

Shift: []

Start: []