Intermediate/Senior Validation Specialists

Intermediate/Senior Validation Specialists

PharmEng USA a division of PharmEng Technology Inc. is an international leader providing Regulatory Affairs, validation, engineering, technology transfer, contract project support (manufacturing and testing) and GMP compliance services to the Medical Device, Pharmaceutical and Biotechnology industry.  Our organization has the offices across North America and Asia. We are recruiting for an Intermediate/Senior Validation Specialist positions in MD area immediately:

 

5-10 years Validation experience in pharmaceutical or biotechnology industries including technology transfer analytical method validation, equipment, environmental, filtration, utility, sterilization, automation qualification, cleaning cycle development, cleaning validation, and process cycle development with a focus on Performance Qualification.

 

 Professional Engineer (PE) or  Life Science DegreeGood interpersonal skills with the customer and end usersGood organizational, management and project tracking skillsGood reporting skills

 

Activities

·  Focus on Performance Qualification

·  Write Protocols

·  Compile Data packs

·  Execute Protocols

·  Write Reports

·  Manage, resolve and report on deviations

·  Interface with the end users

·  Interface with QC to schedule sample analysis

·  Interface with outside laboratories to schedule tests, if applicable

·  Interface with QA when writing protocols and reports

·  Collect samples and deliver to QC

·  Obtain necessary documentation to complete the IQ/OQ.

·  Maintain up to date training records.

·  Read all specific SOP/’s prior to execution of work.

·  Ensure that all appropriate SOP’s are read and understood prior to execution of work in their respective area. 

·  Maintain current cGMP standards and corporate standards for documentation.