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Senior Validation Scientist - Cleaning Validation

Senior Validation Scientist - Cleaning Validation
Empresa:

Bristol Myers Squibb


Lugar:

Manatí

Detalles de la oferta

Summary: Accountable for the design, performance and documentation of validation studies for products manufactured at the pharmaceutical manufacturing sites. This includes the processes, formulation and equipment used in the manufacture of solid and Parenteral products and all related systems, utilities, and services needed to support the manufacturing activities. This position must comply with all Security guidelines, Environmental, Health and Safety regulations and the current Good Manufacturing Practices required by the job function. Major Duties and Responsibilities: 1. Prepares well-documented protocols for all processes to be qualified/validated based on corporate guidelines, procedures, FDA Regulations, and Industry current practices. 2. Coordinates the validation activities with related departments (Engineering, Manufacturing, QC/QA, Technical groups) 3. Develops and controls detailed time and event schedules for all studies/projects assigned. 4. Performs qualification/validation studies as per established protocol. 5. Reports in an accurate and timely manner all the studies/project assigned in accordance with the designed protocol. 6. Evaluates process/equipment performance during the studies in order to determine acceptability, reproducibility, and control. 7. Provides timely and efficient technical support to user on qualified/validated systems/processes. 8. Maintains all documentation records in accordance with cGMPs, company policies and FDA regulations. 9. Maintains an understanding of the current technical and regulatory trends in the pharmaceutical industry. 10. Proposes and formalize alternatives for enhancement to validate a process. 11. Maintains validation programs in conformance with department standards and government/corporate regulation/specification. 12. Utilizes statistical tools and other techniques to assess performance of validation studies. 13. Assists management during FDA inspections by interacting with FDA/auditors during inspection or audits. 14. Provides annual revision of the validation programs covered in the validation Master Plan. 15. Update Operational procedure of equipment/system validated according to actual results. 16. Train impacted personnel by updated operational procedure. 17. Collaborates with internal /external clients as requested and or permitted by immediate supervisor. 18. Provides backup support to the section Associate Director during his/her absence and makes section decision as needed. Knowledge/Skill/Education: • Bachelor Degree in Pharmacy, Chemistry or Chemical / Mechanical Engineering or any other related Science field. • Five (5) years of experience in pharmaceutical manufacturing processes, technologies and aseptic processing equipment for Parenteral and biological dosage forms. • Three (3) years of experience in pharmaceutical technology transfer, process improvements and troubleshooting. • Proficient knowledge of biopharmaceutical formulation processes, Parenteral filling and syringe filling processes. • Proficient knowledge of product and process development, manufacturing scale up, continuous process improvement and troubleshooting processes in conformance with departmental standards and in compliance with regulations. • Detailed understanding of how Parenteral manufacturing processes are controlled and validated. • 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 technology transfer and scale-up activities. • 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 cGMPs, OSHA and FDA Regulations as it applies to pharmaceutical industry. Cleaning validation for manufacturing equipment in-depth knowledge and experience is required


Fuente: Adzuna_Ppc

Requisitos

Senior Validation Scientist - Cleaning Validation
Empresa:

Bristol Myers Squibb


Lugar:

Manatí

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