- Medtronic (Juncos, PR)
- …drive meaningful innovation and enhance our impact on patient care. The Equipment Validation Engineer is responsible for executing validation activities ... to manufacturing and automation equipment. This includes developing and performing validation protocols to ensure equipment, systems, and processes meet regulatory,… more
- 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 (Villalba, 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
- Mentor Technical Group (Ponce, PR)
- …a Process Engineer with strong experience in validations, including Master Validation Plans, IQ, OQ, MSA, PQ, and related activities. + The candidate must ... and have at least two years of experience in validation within a medical device company. + Validation... validation within a medical device company. + Validation lifecycle knowledge / Hands on experience (Writing and… 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
- Quality Consulting Group (Villalba, PR)
- …in Puerto Rico & USA. Responsibilities: + Must have knowledge in Process Validation , Equipment IQ and Computer software validation . + Provides technical and ... 2 years of relevant experience. + Knowledge in Process Validation , Equipment IQ and Computer software validation ....Process Validation , Equipment IQ and Computer software validation . + Investigation and root cause analysis skills +… 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