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Rssvalidation specialist, with more than 18 years of demonstrated success in expediting all facets of critical validation projects and processes for organizations ranging from mid-sized biotech companies to global, multi-billion dollar pharmaceutical corpora

Accomplished validation specialist, with more than 18 years of demonstrated success in expediting all facets of critical validation projects and processes for organizations ranging from mid-sized biotech companies to global, multi-billion dollar pharmaceutical corporations. Effective project coordinator and facilitator, with exemplary record of meeting key deliverables within established timeline, budgetary, and compliance requirements. Expertly support product/technology transfer and troubleshooting processes for biotechnology, parenteral, and solid dosage industries, with management experience across the United States and Puerto Rico. Professional strengths include: • Validation of facilities, utilities, manufacturing equipment, PLC based automated systems, cleaning and manufacturing processes, shipping and holding studies, evaluation of materials and components for the biotechnology, parenteral and solid dosage industries. • Commissioning of utilities and manufacturing equipment for the solid dosage industries. • Product/technology transfer and troubleshooting processes for the biotechnology, parenteral and solid dosage industries. • Exposure to start-up operations of biotechnology, parenteral and solid dosage manufacturing facilities. • Knowledge of regulations that support the manufacturing of pharmaceutical and biotech products. • Quality Assurance, Regulatory Compliance, Project Management and Supervision Skills. • Computer skills included: MS Word, Excel, Power Point and Project. • Bilingual (English and Spanish).

Biologist

Crofton, MD

About Me

Industry:

Science & Biotech

Occupation:

Biologist
 

Education level:

Bachelor

Will Relocate:

Yes

Location:

Crofton, MD

Keywords