Senior Process Validation Scientist
DUTIES & RESPONSIBILITIES
Conducts process validation activities in support of the manufacturing operation for existing and new products/processes. Prepares well documented protocols for all processes (existing or new) to be validated in compliance with corporate guidelines, procedures, FDA Regulations and industry current practices. Executes successful and timely process validation activities as per established protocol. Executes activities according to the Time and Event schedule developed by the site team. Performs in process test as required, analyze validation data and generate conclusions based on test results. Report the validation results in an accurate and timely manner. Performs successful and on time resolution of incidents and deviations related to process validation exercises. Pursues completion of process validation exercises in a timely manner in alignment with the site cycle time initiative. Proposes and formalizes alternatives for enhancement to validate a process. Assures definition with the Regulatory groups of optimal regulatory strategies to support changes to validated processes. Conducts statistical process control and process capability analysis for process validation exercises. Utilize statistical tools and other techniques to assess products/process performance during process validation studies. Investigates and conducts troubleshooting and root-cause analysis of unexpected trends or results related to product quality and financial aspects (i.e. yield) due to material and/or process related factors during process validation studies. Implement accurate and timely solutions; develop and manage plans as needed.
• Bachelor Degree in Pharmacy, Chemistry or Chemical Engineering.• Five (5) years of experience in a pharmaceutical industry with at least three (3) years in solid oral dosage forms. • Proficient technical knowledge/expertise in pharmaceutical manufacturing processes/technologies and processing equipment for oral dosage forms. • Proficient knowledge of process validation, continuous process improvement and troubleshooting processes.• Ability to effectively manage multiple projects at the same time with minimum supervision and to incorporate a wide array of technical principles, concepts and theories in innovative ways to process validation.
• Strong project management skills. • Proficient time management skills, planning and organization capabilities.
• Proven ability to influence and work with people at different levels and departments. • Proven leadership & teamwork skills, self starter, results oriented and build and maintain strong relationships with multiple groups.
• Proficient in Statistical Process Control, Process Capability and Risk Assessment/Management
• Proven assessment, analytical and problem-solving skills.• Proficient presentation skills and Technical Writing/Oral communication skills (English/Spanish)• Proficient in cGMP's, OSHA and FDA Regulations as it applies to pharmaceutical industry.
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