Validation Engineer

Are you ready to join a growing, global drug development and manufacturing organization that puts people first?  Come to Adare!  We work closely with our pharmaceutical industry partners during all phases of drug development and commercial manufacturing with a mission of improving the lives of patients and medicines essential to people all over the world.  Each role and every department within Adare offer you a unique, customized experience with a chance to make a real impact, and is critical to our success.  With the help of people like you dedicated to our mission, Adare is transforming lives by transforming drug delivery!

Join our mission at Adare!

What can Adare offer you?


* Medical/dental/vision/life – low employee premiums


* 401k with a highly competitive match


* Generous PTO, including floating holidays


* Career growth and internal opportunities


* Tuition reimbursement


* Relocation assistance


* Performance-based bonus


* Employee Recognition Programs

We are seeking to hire a Validation Engineer to contribute to our Validation and Technical Services Team…

If any of the below describes you, we would love to meet you!

JOB SUMMARY

In this position, the Validation Engineer will have the following areas of responsibility:  Process Validation, Cleaning Validation, Facility Qualification, and Equipment Qualification.

RESPONSIBILITIES AND LEARNING OPPORTUNITIES

Process Validation:


* Work on all aspects of manufacturing process validation and revalidation, including related change controls.


* Evaluate Critical Process Parameters and Critical Quality Attributes for new products.  Create sampling and testing plan for each process validation protocol.


* Technical writing:  Write process validation protocols and validation summary reports.


* Perform risk assessments of formulations and manufacturing processes.


* Document and close out deviations to protocol.  Investigate causes for failing analytical results and process failures.


* Provides protocol training to Manufacturing and Quality Control personnel.

Cleaning Validation:


* Work on all aspects of cleaning validation and verification, including related change controls.


* Validate the cleaning processes for new equipment and for the cleaning process in existing equipment after making new products.


* Maintain the ongoing annual cleaning verification program.


* Evaluate alternate cleaning agents and methods as needed and their potential impact on the validated status of cleaning processes.


* Technical writing for cleaning validation protocols and validation summary reports.  Write evaluations of alternate cleaning agents and processes.  Write/evaluate new cleaning SOPs.

Facility Qualification:


* Work on all aspects of facility qualification and re-qualification, including related change controls.


* Evaluate changes to the facility and their impact on the validated status of ...