Validation Specialist - Great Salary

SUMMARY: The Equipment (not instrumentation) Validation Specialist Position involves designing, executing and concluding qualification studies as they pertain to Installation, Operational and Performance Qualifications regarding various forms of equipment and utility systems, as well as writing SOPs where applicable.

 


RESPONSIBILITIES include the following:


Designing, executing and concluding studies that pertain to process and cleaning validations. Participating in the execution of scale-up and demonstration studies, and coordination of validation activities as they pertain to specific projects. Providing guidance and training to the QC Laboratory and Operations Department for assisting in the execution of qualification/validation related testing.


Coordinating cross-functional activities with QA, Engineering, Technical Services, Operations and QC during the execution of aforementioned protocols.


Assuring that all activities are performed in compliance with approved validation/qualification protocols, standard operating procedures (SOPs), both company and Technical Support/Validation Departmental policies, and current regulatory requirements/guidelines.


Coordinate all validation activities with internal departments, while providing customer service and support to the manufacturing process.


Coordinate all validation activities with external (client) departments, while providing customer service.
Author validation documentation including, but not limited to, Installation, Operational and Performance Qualification protocols and reports, Process Validation protocols and reports, Cleaning Validation protocols and reports, and Protocol Discrepancies and Addenda.


Document testing results in validation/qualification protocols per protocol requirements.
Provide guidance and training to the QC Laboratory and Operations Department in the execution of validation related activities.


Obtain samples to be analyzed per qualification/validation protocol requirements.


Maintain and organize data associated with the execution of qualification/validation related activities.
Compile and tabulate data to be presented in report form.


Provide the QC Laboratory with Test Request Forms upon sample submission for testing.
Serve as validation liaison in Validation Manager's absence.


Serve as Validation Project Lead in assigned projects.


Assure that all validation activities are performed in compliance with approved validation/qualification protocols, standard operating procedures (SOPs), both company and Technical Support/Validation Departmental policies, and current regulatory requirements/guidelines.


Provide pertinent information/opinion as to the validity of equipment functionality, utility system functionality, a manufacturing process, or cleaning process.

 

Qualifications:

 Requires a Bachelors degree in Science
Strong written and oral communication skills.
Familiar with Microsoft Word and Excel. 
1+ years equipment validation experience in the pharmaceutical industry.
Knowledge of pharmaceutical manufacturing processes and cGMP.
CQE Preferred