Computer System Validation Lead

  • Contractor
  • Full-Time
  • Myerstown
  • Splintpharma
  • Prefferd visa: OPT, CPT, F1, H4, Have H1 Visa, Need H1 Visa, EAD
  • Posted 1 year ago – Accepting applications
Job Detail
  • Offerd Salary $ 35 - $ 45
  • Required Position 2-4 hires
  • Experience 0-3 Years Required
Job Description

Job Opening for Computer System Validation Lead, Myerstown, PA: Client: Bayer Healthcare
We are currently working on below mentioned job opening i., e Job Opening for Computer System Validation Lead, Myerstown, PA: Client: Bayer Healthcare. Please let me know if you are interested in applying for the same.

Job Description: 
Provide Bayer with a CSV Lead who can be a local contributor to handle the Computer Software Validation (CSV) Assessment of the packaging systems and plan for the software validation to follow. The scope of the CSV framework assessment will include the Quality Organization's structure; technology & validation artifacts; procedural documentation
{SOPs, Work Instructions, Forms, Templates); and collaboration with the Quality leadership and stakeholders as directed. The approach will be one of breadth given the functional orientation and sheer volume of systems that will produce a targeted assessment, roadmap and plan for tailoring a CSV framework into a CSA program focused on efficiency, scale, and dissemination tuned to whichever project methodology is employed.
Period of Performance: Aug 1st - TBD
 Access to strategies, plans, stakeholders, and enterprise quality documentation libraries supporting the systems in scope.
Assigned PoC's with decision authority for engagement at regular intervals.
Transparent dialogue with the Business Owner.
 Results Delivered
CSA Assessment with 3 Year Roadmap

Job Requirement

Job Opening for Computer System Validation Lead, Myerstown, PA: Client: Bayer Healthcare
We are currently working on below mentioned job opening i., e Job Opening for Computer System Validation Lead, Myerstown, PA: Client: Bayer Healthcare. Please let me know if you are interested in applying for the same.

Job Description: 
Provide Bayer with a CSV Lead who can be a local contributor to handle the Computer Software Validation (CSV) Assessment of the packaging systems and plan for the software validation to follow. The scope of the CSV framework assessment will include the Quality Organization's structure; technology & validation artifacts; procedural documentation
{SOPs, Work Instructions, Forms, Templates); and collaboration with the Quality leadership and stakeholders as directed. The approach will be one of breadth given the functional orientation and sheer volume of systems that will produce a targeted assessment, roadmap and plan for tailoring a CSV framework into a CSA program focused on efficiency, scale, and dissemination tuned to whichever project methodology is employed.
Period of Performance: Aug 1st - TBD
 Access to strategies, plans, stakeholders, and enterprise quality documentation libraries supporting the systems in scope.
Assigned PoC's with decision authority for engagement at regular intervals.
Transparent dialogue with the Business Owner.
 Results Delivered
CSA Assessment with 3 Year Roadmap

Required skills