Validation Engineer

Adare Pharma Solutions Recruiting Team•Vandalia, OH

About The Position

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 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.

Requirements

BS/BA degree from a four-year accredited university or college in Biology, Chemistry, Engineering, or related field
3+ years’ experience with Validation and Qualification activities in a GMP environment
Ability to continually learn on the job: new equipment, new manufacturing technologies, new raw materials, etc.
Problem solving and trouble-shooting abilities
Capable of scientific observation of processes
Technical writing skills
Good working knowledge of “Good Manufacturing Practices”.
Proficient in Microsoft Office – Word, Excel, PowerPoint, Visio. Statistical software such as JMP.
Ability to coordinate, contribute to, and work within cross-functional teams.
Demonstrates mechanical aptitude.

Responsibilities

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.
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.
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 the cGMP rooms/areas within the facility.
Technical writing for facility qualification protocols and validation summary reports. Write evaluations of changes being made to the facility.
Work on all aspects of equipment qualification and re-qualification, including related change controls.
Work on aspects of critical utility qualification and re-qualification, including related change controls.
Maintain the periodic equipment re-qualification program.
Technical experience and/or expertise in the operation of pharmaceutical equipment including but not limited to tablet presses, blenders, fluid beds, roller compactors, pan coaters, mixers, ovens, capsule fillers, packaging equipment, and other pharmaceutical equipment.
Technical writing: Write equipment qualification protocols and validation summary reports. Write evaluations of changes being made to the equipment as necessary.