Validation Engineer

Adare Pharma Solutions Recruiting Team•Vandalia, OH

1d•Onsite

About The Position

The Validation Engineer is a critical member of the Manufacturing Science and Technology team, and will have responsibility for 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

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 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.
Equipment Qualification: 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.