- 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 (Ponce, PR)
- …Collaborate with local SQEs to develop Product Service Segmentation (PSS), validation plan, complete change implementation activities and supplier audit scheduling + ... Reviews and approves supplier validation documentation to ensure good manufacturing practices (GMP) and...We have the talent, diverse perspectives, and guts to engineer the extraordinary. Learn more about our business, mission,… 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
- 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
- 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
- Quality Consulting Group (Villalba, PR)
- …+ Two (2+) years of relevant experience + Hands-on and proactive engineer + Continuous improvement mindset + Experience with agile, lean manufacturing concepts ... and transformations + Experience in equipment & process validation + Experience in cost analysis + Project management and analytical problem-solving skills +… more
- Quality Consulting Group (Ponce, PR)
- …plan at incoming and supplier, evaluate proper inspection method, and change control. + Engineer will be a liaison between supplier, Ponce Site and clients COE + ... Define Receiving Inspection requirements as required and associated test method validation for all internal clients Test Methods. Qualifications: + Bachelor's degree… 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
- Quality Consulting Group (Villalba, PR)
- …+ Minimum of 2 years of relevant experience + Knowledge in Process Validation , Equipment IQ and Computer Software validation + Technical writing knowledge ... and Communication skills + Investigation and root cause analysis skills + Must have good writing skills and communication skills in English and Spanish + Administrative Shift Quality Consulting Group, LLC is an equal opportunity employer, and all qualified… 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
- 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
- J&J Family of Companies (San Lorenzo, PR)
- …of the negative trends and in alignment with the Process Engineer , Quality Engineering, manufacturing, and facilities the implementation process. + Analysis ... Quality Control (QC), Quality Standards, Quality Systems Documentation, Quality Validation , Science, Technology, Engineering, and Math (STEM) Application, Technologically… more