GENERAL DESCRIPTION

Develop cleaning validation studies, protocols and reports, executable instructions in support of plant operations. Responsible to support risk assessments and implement data integrity requirements to the executable cleaning instructions, transfer of cleaning documentation to new digital platform, all while working with a multidisciplinary implementation team.

RESPONSIBILITIES
Under limited supervision and in accordance with the laws, federal regulations, and applicable state and local policies, procedures and guidelines, this position has the following tasks and duties.
1.    Active participation on Cleaning Validation team meetings to provide input on projects timeline considerations, activities, escalations and status of assigned tasks.
2.    Evaluate and understand cleaning processes.
3.    Evaluate paper forms, protocols, process and equipment cleaning instructions to transfer them to new digital platform. 
4.    Assess work centers equipment capability and cleaning instructions for improvement purpose.  
5.    Serve as Subject Matter Expert to develop cleaning validation protocols, reports, executable instructions and implementation of additional data integrity requirements. 
6.    Revise and approve cleaning strategy documents.
7.    Participate in the revision of the cleaning documentation records related to the manufacturing stages and steps.
8.    Lead and/or participate on triage activities to assess change control requirements. 
9.    Issuance or support on change control generation.
10.    Issuance change control and present it in Change Control Board to pursue approval of the change. 
11.    Review documentation associated to cleaning program (cleaning validation master plan, risk assessment, protocols, reports, working instructions, sampling scheme, limit calculations, etc.).
12.    Revise equipment cleaning instructions while transferring to new digital platform.
13.    Revise SOPs related to cleaning program and requirements. 
14.    Participate /lead the data integrity assessment and actions for cleaning program. 
15.    Lead trainings activities provided to manufacturing operators. 
16.    Support On Call rotation for cleaning execution activities. 
17.    100% dedicated to cleaning validation program
18.    Comply with Individual Learning Plan Requirements including qualification modules for Darwin, Trackwise, VEEVA (Quality Docs) among others.
19.    Comply with additional tasks requested by supervisor.

•    BS Science or Engineering
•    Minimum five (5) years of experience related to cleaning development and validation documents writing (protocol, cleaning checklist and risk assessment), cleaning swab testing and final reports.
•    Experience and training in FDA GMP.
•    Good interpersonal skills with an assertive and pro-active approach towards work.
•    Excellent communication skills (English and Spanish).

*Weil Group is proud to be an Equal Employment Opportunity Employer.*