Average salary: $87,659 /yearly
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- ...validation activities Develop, execute, and review CSV lifecycle documentation Ensure computerized systems comply with GMP and regulatory requirements Support risk assessments, testing, and validation reports Collaborate with IT, Quality, and Engineering teams...Regulatory
Validation & Engineering Group, Inc
Puerto Ricoa month ago - ...-specification results during transfer activities. Collaborate with method development, quality assurance, manufacturing, and regulatory teams. Support troubleshooting, method optimization, and lifecycle management after successful transfer. Qualifications:...RegulatoryWeekend work
Validation & Engineering Group, Inc
Puerto Rico9 days ago - ...biotechnology industries. Must be fully bilingual (English / Spanish) with excellent oral skills. Strong knowledge in cGxP and regulatory guidance as well as understanding of how they are applied to regulatory compliance. Understanding of ASTM E2500 methodologies....RegulatoryWeekend work
Validation & Engineering Group, Inc
Puerto Rico5 days ago - ...introductions. ? Drive cross-functional coordination across Manufacturing, QA, QC, Validation, Engineering, Supply Chain, MS&T, and Regulatory. ? Develop and execute Technology Transfer Plans with clear milestones and deliverables. ? Ensure successful implementation...RegulatoryWork at officeShift workWeekend work
Validation & Engineering Group, Inc
Puerto Rico15 days ago - ...a GMP-regulated manufacturing operation. This role plays a key part in ensuring systems used for cleaning and sanitization meet regulatory requirements and are fit for intended use. Key Responsibilities: • Execute IQ, OQ, and PQ for alcohol systems, including tanks...Regulatory
Validation & Engineering Group, Inc
Puerto Rico7 days ago - ...FMEA, hazard analysis), root cause investigations, and CAPA systems. • Proven collaboration with Operations, Quality Assurance, Regulatory, R&D, and Supply Chain teams. • Familiarity with controlled documentation systems, engineering change processes, and manufacturing...RegulatoryContract work
Pinnaql
Puerto Rico19 days ago - ...Requirements: Knowledge of Change Control processes. Experience with Computerized Systems Validation (CSV). Familiarity with regulatory requirements in the pharmaceutical industry. Ability to multitask and prioritize work effectively. Strong problem-solving...Regulatory
Validation & Engineering Group, Inc
Puerto Rico29 days ago - ...introductions (NPI)** and **product transfers** into manufacturing operations. Ensure that new and transferred products meet all quality, regulatory, and operational requirements prior to release. Support manufacturing and product development teams to enable the successful...RegulatoryWeekend work
Validation & Engineering Group, Inc
Puerto Rico19 days ago - ...activities within a regulated cGMP manufacturing environment. This role is critical in ensuring equipment cleaning processes meet regulatory and quality compliance standards. Key Responsibilities Lead cleaning validation lifecycle activities Develop & review...Regulatory
Validation & Engineering Group, Inc
Puerto Rico14 days ago - ...to address root causes and prevent recurrence. Prepare clear, accurate, and compliant investigation reports that meet GMP and regulatory requirements. Collaborate cross-functionally with Operations, Quality Assurance, Engineering, and Maintenance to resolve quality...RegulatoryWeekend work
Validation & Engineering Group, Inc
Puerto Rico27 days ago - ...Quality Labeling Engineer provides on-site technical support for labeling (for example system and artwork update implementation) and regulatory compliance projects (for example MDD / EU MDR related implementations). Possesses technical responsibility for interpreting,...RegulatoryWork at office
Validation & Engineering Group, Inc
Puerto Rico29 days ago - ...initiatives. The role will ensure project activities are delivered in alignment with program objectives, quality standards, and regulatory requirements within a pharmaceutical manufacturing environment. Scope: Provide leadership and coordination for automation-related...RegulatoryWeekend work
Validation & Engineering Group, Inc
Puerto Rico20 days ago - ...Collaborate with cross-functional teams including Engineering, Quality, and Operations. Ensure compliance with internal procedures and regulatory requirements. Qualifications: Bachelor’s degree completed (Engineering or related technical field preferred). Co-op or...RegulatoryInternshipWeekend work
Validation & Engineering Group, Inc
Puerto Rico8 days ago - ...excellent oral skills. Must be proficient using MS Windows and Microsoft Office applications. Strong knowledge in cGxP and regulatory guidance as well as understanding of how they are applied to regulatory compliance. Experience in Design Documentation (URS, DS...RegulatoryWeekend work
Validation & Engineering Group, Inc
Puerto Rico13 days ago - ...is focused on maintaining accurate, organized, and readily retrievable GMP and business records to support day-to-day operations, regulatory compliance, and inspection readiness. Working in accordance with Good Documentation Practices (GDP) and site procedures, the...RegulatoryShift work
Validation & Engineering Group, Inc
Puerto Rico13 days ago - ...commercialization of biologics, gene therapies, and cell therapies. Operating as a cGMP incubator, OcyonBio maintains robust quality systems, regulatory oversight, and technical expertise to generate CMC data suitable for global regulatory submissions. We are committed to...RegulatoryLocal areaFlexible hoursWeekend work
Biosimilar Sciences PR LLC
Puerto Rico15 days ago - ...maintenance team operations and activities are maintained in compliance with respect to current corporate policies, industry standards, regulatory standards and FDA standards. Responsibilities: Ensure utility systems, process maintenance, instrumentation/calibration/...RegulatoryWeekend work
Validation & Engineering Group, Inc
Puerto Rico29 days ago - ...excellent oral skills. Must be proficient using MS Windows and Microsoft Office applications. Strong knowledge in cGxP and regulatory guidance as well as understanding of how they are applied to regulatory compliance. Technical Writing skills and investigations...RegulatoryFor contractorsWeekend work
Validation & Engineering Group, Inc
Puerto Rico13 days ago - ...organization on various teams, Independently responsible for following through on multi-site action items. May interact with regulatory agencies regarding area(s) of responsibility including written responses. May resolve issues with outside resources. Performs...RegulatoryShift work
Validation & Engineering Group, Inc
Puerto Rico14 days ago - ...organization on various teams, independently responsible for following through on multi-site action items. May interact with regulatory agencies regarding area(s) of responsibility including written responses. May resolve issues with outside resources. Performs...RegulatoryShift workWeekend work
Validation & Engineering Group, Inc
Puerto Rico19 days ago - ...excellent oral skills. Must be proficient using MS Windows and Microsoft Office applications. Strong knowledge in cGxP and regulatory guidance as well as understanding of how they are applied to regulatory compliance. Experience in Design Documentation (URS, DS...RegulatoryFor contractorsFor subcontractorWeekend work
Validation & Engineering Group, Inc
Puerto Rico13 days ago - ...biotechnology industries. Must be fully bilingual (English / Spanish) with excellent oral skills. Strong knowledge in cGxP and regulatory guidance as well as understanding of how they are applied to regulatory compliance. Technical Writing skills and...RegulatoryWeekend work
Validation & Engineering Group, Inc
Puerto Rico23 days ago - ...responsible for executing and supporting validation activities for equipment, processes, and computerized systems in compliance with regulatory requirements and industry standards. Responsibilities: Develop, review, and execute validation protocols including IQ, OQ,...RegulatoryWeekend work
Validation & Engineering Group, Inc
Puerto Rico11 days ago - ...excellent oral skills. Must be proficient using MS Windows and Microsoft Office applications. Strong knowledge in cGxP and regulatory guidance as well as understanding of how they are applied to regulatory compliance. Experience in Design Documentation (URS, DS...RegulatoryWeekend work
Validation & Engineering Group, Inc
Puerto Rico14 days ago - ...excellent oral skills. Must be proficient using MS Windows and Microsoft Office applications. Strong knowledge in cGxP and regulatory guidance as well as understanding of how they are applied to regulatory compliance. Experience in Design Documentation (URS, DS...RegulatoryWeekend work
Validation & Engineering Group, Inc
Puerto Rico22 days ago - ...excellent oral skills. Must be proficient using MS Windows and Microsoft Office applications. Strong knowledge in cGxP and regulatory guidance as well as understanding of how they are applied to regulatory compliance. Technical Writing skills and investigations...RegulatoryFor contractorsFor subcontractorWeekend work
Validation & Engineering Group, Inc
Puerto Rico13 days ago - ...health & safety, and operations. We are committed to excellence, innovation, and ensuring alignment with technical, operational, and regulatory requirements. Position Summary The Buyer / Procurement will be responsible for planning, coordinating, and executing all...RegulatoryWork at office
Smart Precise Solutions, Inc.
Puerto Rico22 days ago - ...from early development through pre-clinical, clinical, and commercial stages. We operate as a cGMP incubator environment with full regulatory systems capabilities and resources to generate CMC data supporting global regulatory applications. Our manufacturing and...RegulatoryWork at officeLocal area
Biosimilar Sciences PR LLC
Puerto Rico6 days ago - ...stated purpose. Maintain processes in a state of compliance with US and global regulations, including cGMPs and applicable global regulatory manufacturing guidance. Support ongoing manufacturing at External Partners through process monitoring, issue response, and...RegulatoryWork experience placementLocal areaWeekend work
Validation & Engineering Group, Inc
Puerto Rico28 days ago - ...change management, security controls, and access management Ensure enterprise applications comply with institutional policies, regulatory requirements, and industry standards (e.g., FERPA, GDPR, PCI) Support audit activities, security assessments, and data...RegulatoryTemporary work
NUC University
Puerto Rico28 days ago
