- Kelly Services (Arroyo, PR)
- **Kelly(R) Engineering** is seeking ** Validation Specialist** for contract position at manufacturing client in **Arroyo,** Puerto Rico. If you're passionate about ... used. **Requirements** BD in Engineering Previous experience releated + TMV (test method validation ) + Creation SOPs + Protocols and reports on IQ/OQ/PQ + Supplier… more
- Quality Consulting Group (Juncos, PR)
- …in Puerto Rico & USA. Responsibilities: + Perform and/or review process validation [PV: characterization, OQ, PQ] (not cleaning process) and equipment qualification ... laboratory). + Experience in production line. + Basic knowledge in defining validation strategies (eg requirements flow down from design to manufacturing). +… more
- Quality Consulting Group (Juncos, PR)
- …including requirements, design, development, documentation, integration, test, verification and validation . + Defines appropriate measures to ensure product quality. ... tools, techniques, and methodologies. + Provides or directs verification and validation of software system requirements, traceability, and testability. + Performs… more
- Stryker (Arroyo, PR)
- …and Special Orders. + May assist during new product development. Validation support for product, processes, packaging, software, and sterilization. + Analyze ... Lead in development, review and approval of process and equipment validation /qualifications. Supervisory Responsibilities: + May coordinate the activities of one or… more
- Quality Consulting Group (Juncos, PR)
- …as they apply to product or process quality. + Performs and/or review process validation (not cleaning processes) and equipment documents: URS, FAT, IQ, OQ, PQ, TMV ... Minitab). + Knowledge of equipment Commissioning/Qualification. + Knowledge of Process validation and Computer software validation (eg requirements flow down… more
- Mentor Technical Group (Juncos, PR)
- …maintenance, process development, utilities, facilities, quality assurance and/or validation departments in developing requirements and recommendations for system ... support + Working knowledge of pharmaceutical/biotech processes + Familiarity with validation processes + Familiarity with documentation in a highly regulated… more
- Quality Consulting Group (Juncos, PR)
- …including requirements, design, development, documentation, integration, test, verification and validation . + Defines appropriate measures to ensure product quality. ... techniques, and methodologies. + Provides or directs verification and validation of software system requirements, traceability, and testability. Qualifications: +… more
- Quality Consulting Group (Juncos, PR)
- …Experience with Risk management documentation: pFMEAs + Perform and/or review process validation (not cleaning processes) and equipment documents: URS, FAT, IQ, OQ, ... knowledge in statistics (preferably using Minitab) + Basic knowledge in defining validation strategies (eg requirements flow down from design to manufacturing) +… more
- Mentor Technical Group (Juncos, PR)
- …maintenance, process development, utilities, facilities, quality assurance and/or validation departments in developing requirements and recommendations for system ... reporting to site leadership on project matters.. Monitoring and evaluating engineer /contractors physical progress. + Addressing progress and delay claims from… more
- BD (Becton, Dickinson and Company) (Humacao, PR)
- **Job Description Summary** The Senior Packaging Engineer will lead the development and implementation of packaging solutions for medical devices at BD Humacao. This ... packaging systems meet performance, regulatory, and operational requirements. The engineer will work closely with cross-functional teams to support production,… more
- Quality Consulting Group (Juncos, PR)
- …maintenance, process development, utilities, facilities, quality assurance and/or validation departments in developing requirements and recommendations for system ... documentation practices for regulated industries. + Comprehensive understanding of validation protocol execution requirements. + Basic technical presentations o… more
- Quality Consulting Group (Juncos, PR)
- …degree in Engineering + 4 years of relevant experience + Proficient in validation process, CSV, PV + Proficient in Troubleshooting, Equipment Setups + Proficient in ... control of Medical Devices + Equipment Commissioning / Qualification + Process Validation 4. Computer System Validation (CSV) + Manufacturing, Packaging and… more
- Stryker (Arroyo, PR)
- …of the Reliability program. Overseen and/or execute the development, construction, and validation of new equipment and/or utilities. Supports in the selection of ... related activities + Provide guidance in the development, procurement, construction, and validation of new equipment and/or utilities + Plan, coordinate and execute… more
- Mentor Technical Group (Caguas, PR)
- …on the quality and reliability of the product - assist in process validation protocol. * Follow-upon commitments to FDA and ISO observations for manufacturing ... related issues and report trends. * Perform quality system audits to determine compliance to FDA, ISO, and internal quality systems regulations and perform quality system surveys to evaluate the overall quality capability of a prospective or actual supplier or… more
- Quality Consulting Group (Humacao, PR)
- …+ 2 to 5 years of relevant experience + Knowledge in Process Validation and Computerized System Validations + CAD Design proficiency + Microsoft Excel proficiency ... with complex spreadsheet development + Availability for 1st shift Quality Consulting Group, LLC is an equal opportunity employer, and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual… more
- West Pharmaceutical Services (Cidra, PR)
- …on site and support Facilities and Utilities where required. + Support commissioning/ validation on existing and new projects. + Lead the scheduled calibrations and ... safety rules. + Work to identify opportunities for improvements. + Work with Maintenance Engineer and Quality Engineers to ensure PM program is kept up to date. +… more
- Mentor Technical Group (Gurabo, PR)
- …America. Responsibilities: + Review and approve product MPs. + Approve process validation protocols and reports for manufacturing processes. + Request Quality on ... OR Associates + 8 years of directly related experience in Life Science or Engineer Mentor Technical Group es un empleador que ofrece igualdad de oportunidades y… more