Senior Validation Engineer

Job Title: Senior Validation EngineerLocation : Anasco, PRDescriptionPlans, develop, and implement documentation, procedures, and training necessary for the engineering team, production and quality personnel. Generation and execution of change controls, validation plans, validation protocols (FAT/SAT/IQ/OQ/PQ/CSV’s), and completion reports. Provide statistical analysis of the date to support the reports. Develop statistically based sampling plans for in-process and final testing and inspections, and validations. Review and approve validations and completion reports for new and existing products, processes and equipment. Troubleshooting equipment/processes that do not perform as intended during validation runs.

Recommend process/quality improvements as part of validation runs. Work with new and existing equipment, processes, utilities, facilities and cleaning validations, to include (but not limited to) Packaging Equipment (e. g. Multivac Machine), freeze-drying, CCA, DIUF, RO/DI, WFI, Pure Steam, SIP Systems, HEPA Filters, chillers, controlled temperature units, and laboratory equipment. Evaluate, investigate and document non-conformances incidents and/or protocol deviations. Develops and maintains an effective cross-functional working relationship with plant and corporate Manufacturing, Engineering, Regulatory, and Quality Assurance personnel. Work on project teams with other internal departments, external vendors, and customers as required.

Assure that existing processes and assigned activities fully comply with regulatory and/or international agencies, such as FDA, ISO, OSHA, EPA, among others. Performs other related duties as necessary. BS in Engineering preferably Mechanical, Industrial, Electrical, Chemical, or Biomedical or science related discipline. Lean/Six Sigma Green or Black Belt Certification is a plus. Experience in validations such as: packaging equipment, manufacturing equipment, laboratory equipment, cleaning, test method, computer systems, shipping, shelf life (aging), sterilization, facilities, clean rooms, and utilities (HVAC, Compressed Air, Water Systems) required.

Minimum of 5 - 7 years of experience in the medical device and/or pharmaceutical manufacturing environment; with at least five (5) years in a validation engineering position. Knowledge of Packaging components and equipment is highly desirable. Knowledge of FDA, BSI, OSHA, EPA, and GMP's and ISO requirements. Knowledge in Organizational Excellence and Lean/Six Sigma. Ability to lead teams through complex projects and provide departmental technical leadership. Must have excellent communication skills and a strong track record of working cross-functionally. Must have demonstrated ability to think strategically. Able to develop technical documentation such as:

Change Controls, Validation Plans, Validation Protocols, Technical / investigation reports, SOP, and others. Teamwork oriented and self-starter Fully bilingual. Able to work on different/extended shifts and/or non-working days when required. This position requires to work on site.