- Mentor Technical Group (Juncos, PR)
- …Canada, and South America. Responsibilities: + Development of Characterization and Validation protocols + Execution of Characterization and Validation protocols ... experience. + Fully Bilingual (Spanish and English) + Characterization and Validation experience + URS, DS, and Equipment Risk Assessments + Device… more
- Mentor Technical Group (Juncos, PR)
- …Republic, Mexico, Germany, Canada, and South America. Responsibilities: + Develop Validation Process (IQ, PQ, OQ) Education & Qualifications: + Bachelor's degree ... and 3 years of experience + Fully Bilingual (Spanish and English) + Validation experience + URS, DS, and Equipment Risk Assessments + Device assembly equipment… more
- J&J Family of Companies (Gurabo, PR)
- …Description:** Janssen Ortho LLC is looking for a **Senior Quality Assurance Specialist , CSV** **(Computer System Validation )!** This position can be located ... Medicine) Supply Chain site. This role involves overseeing the process validation of manufacturing and packaging documentation while evaluating hardware and software… more
- Mentor Technical Group (Carolina, PR)
- …(eg, URS, SRS, FRS, DDS, RTM, Unit, Integration, User Acceptance testing, FAT, SAT, Validation Planning, IQ, OQ, PQ, Final Validation Summary Report). + Working ... knowledge of the development of protocols for the Validation of complex computer systems (eg, multiple GAMP classes of systems); Protocol development will include… more
- Mentor Technical Group (Juncos, PR)
- …the execution of manufacturing/quality systems such as non-conformances, process validation , procedures, training, and new product introductions. Apply process, ... equipment/system Root Cause Analysis investigations and support trend evaluations. Process Validation 1. Assist with generation of process validation protocols… more
- Kelly Services (Juncos, PR)
- …you find a job that works for you. How about this one?** We're seeking ** Specialist QA ** to work for one of our top **Biotechnology Industry client at Juncos, ... and experience with processes involved in manufacturing and distribution, QA, QAL, validation and process development. + Knowledge of cGMP's and compliance +… more
- Kelly Services (Manati, PR)
- Kelly(R) Engineering is seeking **Senior Process Automation Specialist ** for a **12 month** contract position at a Global Pharmaceutical client in **Manati, Puerto ... pharmaceutical environment with two (2) years' experience in computerized systems validation . + Proficient knowledge of computer system life cycle concepts, change… more
- Quality Consulting Group (Juncos, PR)
- …the execution of manufacturing/quality systems such as non-conformances, process validation , procedures, training, and new product introductions. + Apply process, ... support trend evaluations. + Assist with generation of process validation protocols and reports. + Assist with the execution...reports. + Assist with the execution of the process validation . + Participate in the NPI process to assess… more
- Fujifilm (San Juan, PR)
- **Position Overview** The accomplished Senior Corporate Compliance Specialist will support FUJIFILM's Corporate Compliance Program's operations to ensure high ... plans, and prepare related reports. + Manage transparency data collection, validation , and reporting process to ensure compliance with the applicable transparency… more
- Quality Consulting Group (Juncos, PR)
- …USA. Responsibilities: + Review and approve product MPs. + Approve process validation protocols and reports for manufacturing processes. + Request Quality on ... have) + Be knowledgeable about compliance and regulatory aspects for equipment validation , operation and maintenance (must have) + Be knowledgeable about compliance… more
- Quality Consulting Group (Juncos, PR)
- …USA. Responsibilities: + Review and approve product MPs. + Approve process validation protocols and reports for manufacturing processes. + Request Quality on ... experience with processes involved in manufacturing and distribution, QA, QAL, validation and process development. + Demonstrate ability to interact with regulatory… more
- Mentor Technical Group (Caguas, PR)
- …interoperability. + Ensure data quality, accuracy, and integrity through robust validation and monitoring practices. + Manage data sources across categories such ... as People, Quality, Safety, Service Delivery, and Cost, ensuring relevance and alignment with business objectives. + Communicate insights effectively to both technical and non-technical stakeholders to drive actionable outcomes. Qualifications… more
- Mentor Technical Group (Carolina, PR)
- …the execution of manufacturing/quality systems such as non-conformances, process validation , procedures, training, and new product introductions. + Apply process, ... operational, and scientific expertise, basic compliance knowledge, and analytical and troubleshooting skills to support manufacturing operations. + May serve as primary production process owner for process support systems and assist with process ownership… more
- Banco Popular Puerto Rico (San Juan, PR)
- …and Responsibilities + Assist in defining and establishing accreditation and validation strategies from an engineering perspective. + Responsible for gathering, ... of security aspects. + Solution and design security accreditation and validation strategy from an engineering perspective. + Collaborate with Security Architecture… more
- Amgen (Juncos, PR)
- …solve broad and complex technical challenges. + Serve as a peer-recognized specialist in at least one engineering domain, responsible for determining methodologies ... research, manufacturing, process development, utilities, facilities, quality assurance, and validation teams to define requirements and recommend large-scale or… more
- Vontier (San Juan, PR)
- …Support acceptance/pilot testing + Maintaining and improving area of specialist knowledge, undertaking training where appropriate **Software development** + Automate ... agreed quality standard + Maintain and improve area of specialist knowledge by keeping up to date with advances...and reverted as required **Software testing & Release** + Validation automated and manual test plan coverage. + Co-ordination… more
- Haleon (Guayama, PR)
- …with existing systems. + Own the development and execution of Computer System Validation Master plan and implementation on new projects. + Lead the North America ... to optimize production performance. + Provide subject matter expertise and specialist technical advice: + Input to automation engineering and digital solutions… more