Adare Pharma Solutions · 11 hours ago
Validation Engineer
Vandalia, OH
Full-time
Onsite
Mid Level
3+ years expAdare Pharma Solutions is a growing, global drug development and manufacturing organization dedicated to improving the lives of patients. The Validation Engineer will be responsible for process validation, cleaning validation, facility qualification, and equipment qualification, ensuring compliance with Good Manufacturing Practices.
ManufacturingPharmaceuticalLogisticsCommercialPackaging ServicesProduct Design
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
Qualification
Required
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
Benefits
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
Company
Adare Pharma Solutions
Adare Pharma Solutions is a technology platform that offers research, development, manufacturing, and delivery of pharmaceutical products.
501-1000 employees
Funding
Current Stage
Late StageLeadership Team
T
Tom Sellig
Chief Executive Officer
Recent News
The Philadelphia Inquirer
2025-12-09
Morningstar.com
2025-10-21
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