- 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
- Medtronic (Juncos, PR)
- …**Job Summary:** We are looking for a results-driven and innovative Principal Process Engineer / Project Lead to drive the process evaluations, solution and project ... from concept through production release, including equipment installation, process validation , and process monitoring and control. The successful candidate will… 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
- 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 ... 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
- 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
- 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
- Kelly Services (Arroyo, PR)
- **Kelly(R) Engineering** is seeking **Manufacturing Engineer ** for contract position at manufacturing client in **Arroyo,** Puerto Rico. If you're passionate about ... products, or processes deficiencies. Ensures manufacturing documentation and process validation are complete, accurate and within GMP compliance. **Responsibilities:**… 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
- Medtronic (Juncos, PR)
- …with IT, Quality, and Operations to ensure data integrity, traceability, and system validation (21 CFR Part 11, GxP). + Drive global governance and standardization ... + **Operational & Hands-On Execution** + Oversee deployment, integration, and validation of MES, OPC-UA gateways, historians (OSIsoft PI), and analytics platforms.… 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