Responsible for supporting equipment qualification and process validation programs including creation and execution of protocols (including sampling and process monitoring) as well as writing/routing/obtaining approval of final reports. The specialist is expected to work cooperatively with Regulatory Affairs, Operations, Quality Assurance, Research & Development and Product Compliance.
- Create and coordinate approval of equipment qualification protocols and reports in line with established validation policies and procedures.
- Create and coordinate the approval of process validation protocols and summary reports in line with established validation policies and procedures.
- Create and coordinate approval of cleaning validation protocols/reports and associated documentation in line with established validation policies and procedures
- Create and coordinate the approval of continued process validation verification plans/reports in line with established validation policies and procedures.
- Assure validation documentation is available for operation activities.
- Responsible for assisting in the validation impact assessment regarding changes to validated systems and processes.
- Troubleshoot/investigate validation-related issues.
- Maintain completed validation and qualification packages.
- Execute or assist execution of approved validation and qualification protocols, requiring product monitoring and sampling and also communicating activities.
- Attend meetings as required to ensure validation activities are tracking to project schedules.
- High School Diploma / GED
- Bachelor’s Degree
- Associate’s Degree
- Master’s Degree or Ph.D.
- 5+ years' experience performing equipment/facilities qualification and/or Process Validation within the Pharmaceutical industry.
- Working knowledge of various manufacturing process including those used granulation, drying, sizing, blending, compression, encapsulation, coating, printing, and laser drilling.
- Knowledge of current applicable regulatory standards (FDA, CFR, ICH etc.)
- Experience in data analysis, technical report writing, root cause analysis, and risk assessment.
- Strong initiative and integrity as well as strong written and verbal communication skills
- Proficiency with Microsoft Office suite preferred.
- Proficiency with MiniTab, SAS, or other statistical data processing software preferred.
- Ability to prioritize, organize, give appropriate attention to detail, and work effectively with minimal supervision including strong follow-up skills, and the ability to provide timely closure of assigned tasks is requireds
- Competent in English (both written and verbal). Strong technical writing skills with attention to detail and verbal/written communication skills preferred.
- Traditional office environment, with frequent walking to other areas of the facility, including production areas, loading docks, mechanical spaces and warehouse