Qualified Sr. Validation Engineer with 7+ years of validation/manufacturing experience in the liquid injectable pharmaceutical industry. In-depth knowledge of cGMP regulations and SOP requirements involved in the validation and qualification of component and terminal sterilizers, depyrogenation ovens, lyophilizers, fillers, washers and packaging equipment. Focused on achieving success and increased productivity through improvements in operations and quality.
Testing, Evaluation and Analysis:
Wrote validation protocols (IQ, OQ, PQ) and reports for terminal and component sterilizers, depyrogenation ovens, lyophilizers, TL fillers, IMA Washers and various packaging equipment. Experience with HEPA testing and air flow visualization. IQ, OQ, PQ of new Kaye Vadlidator software and hardware changes. Revised & updated SOP procedures, work instructions and checklists, including the Validation Master Plan. Maintained current knowledge about the latest operating and validation practices with continuing education courses. Trained, developed and counseled employees to develop a high performing team. Completed key projects on time, on budget and with a high level of accuracy. Developed and maintained strong and clear communication and rapport with plant personnel. Communicated effectively with operators, other supervisors and direct reports on a technical level. Collaborated with the engineering team to adjust and modify production equipment. Optimized scheduling based on deep expertise of machine capacities and equipment. Prepared accurate specifications for purchase of materials and equipment for purchasing department, including bag sealer, production components to help with fill room cleaning, and filler setup equipment. Experience with annual product validation summaries and preparation of regulatory documents. Prepared/Facilitated validation portion of internal/external audits and FDA Inspections.
Assessed and trained personnel for promotion to cross-functional operations. Trained new scientists and implemented new training program to improve cross-training and increase abilities of group to perform requalifications, on terminal, component, and laboratory sterilizers, depyrogenation ovens, washers, fillers, and packaging equipment. Established and adjusted work procedures to meet production schedules. Coordinated closely with quality control regarding protocols awaiting dispositions. Experience with ECR's, Trackwise, Documentum and Calibration Manager System. Made sound and logical judgments regarding process changes. Executed qualification work with little to no supervision, including new EU Approved Cycle.
Collaborated with team of Validation experts in the development/validation/installation of a new SBM Aquatherm Sterilizer. Perform qualifications, requalifications, on terminal, component and laboratory sterilizers to maintain equipment in a validated state. Coordination of project and equipment scheduling for new qualifications and routine requalifications. Experience with calibration and welding of thermocouples.
Performed student background reviews to develop tailored lessons based on student needs. Coordinated after school science/math tutoring hours to help students in need of extra attention. Developed and implemented interesting and interactive learning mediums to increase student understanding of course materials. Designed lesson plans focused on age and level-appropriate material (Grades 9-12).
Experience with writing protocols for IQ/OQ/PQ of new equipment. Knowledgeable in the CAPA, Internal Audit systems and
processes, ensuring compliance with established internal, corporate, and
Excellent communication skills and logical skills, systematic approach and
ability to work effectively in a fast paced environment, flexibility of working both individually and as a team member.
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