Average salary: $87,659 /yearly
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- ...culture and purification systems, as well as leadership experience in cross-functional environments supporting project delivery, regulatory compliance, and schedule milestones. Key Responsibilities: Leadership & Project Management Lead CQV efforts for upstream and...RegulatoryFor contractors
Validation & Engineering Group
Puerto Rico4 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
Puerto Rico21 days ago - ...and draft final reports. Manage deviations, CAPAs, investigations, and risk assessments associated with media fills. Support regulatory audit readiness and provide technical justification during inspections. Ensure compliance with FDA Aseptic Processing Guidance...Regulatory
Validation & Engineering Group
Puerto Rico7 days ago - ...out-of-specification (OOS) results, and non-conformances. The role ensures all investigations are performed according to GMP and regulatory standards , with accurate root cause analysis and timely closure. Key Responsibilities Lead and document investigations...RegulatoryContract work
Validation & Engineering Group
Puerto Rico27 days ago - ...The ideal candidate will be responsible for designing, implementing, and maintaining manufacturing processes in compliance with regulatory standards. Additionally, this role will involve validating equipment and processes to ensure efficiency and quality in our manufacturing...Regulatory
Validation & Engineering Group
Puerto Rico12 days ago - ...ensures that equipment, systems, and utilities are installed, commissioned, and qualified per design intent, user requirements, and regulatory expectations to support successful start-up and commercial readiness. Key Responsibilities: Project Leadership & Planning...Regulatory
Validation & Engineering Group
Puerto Rico3 days ago - ...airflow or equipment performance. Ensure compliance with ISO 14644-1/2, EU Annex 1 airflow requirements, and ASTM E2500. Support regulatory inspection readiness and provide airflow-related technical responses. Required Qualifications ~ Bachelor’s in Mechanical...Regulatory
Validation & Engineering Group
Puerto Rico7 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. SDLC: URS, VP, FDS, DQ, TMX, Risk Assessment...RegulatoryWeekend work
Validation & Engineering Group
Puerto Rico29 days ago - ...Science or Engineering discipline. Other disciplines and/or equivalent job experience will be considered. Strong understanding of Regulatory Guidance Framework FDA/EU, Industry Best Practices and cGMPs. Strong problem-solving and critical thinking skills with...RegulatoryFor subcontractorWork at office
Validation & Engineering Group
Puerto Rico4 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
Puerto Rico15 days ago - ...more complex reports utilizing various resources. - Ensure project work complies with domestic (may also involve international) regulatory requirements and approved guidelines relevant to area of responsibility. - Ensure project work complies with practices,...Regulatory
Validation & Engineering Group
Puerto Rico17 days ago - ...external counsel, and internal stakeholders to organize case files, track deadlines, prepare legal documents, and support litigation, regulatory, and compliance matters across multiple jurisdictions. Essential Functions: Case Management & Legal Support Manage and...RegulatoryContract workWork at officeRemote work
InGroup International LLC
Puerto Rico6 days ago - ...bioburden reduction filtration systems. The ideal candidate will have prior experience with biotech processes, familiarity with regulatory standards (FDA/EU Annex 15), and the ability to work cross-functionally with engineering, QA, and operations teams. Key Responsibilities...Regulatory
Validation & Engineering Group
Puerto Rico4 days ago - ...performance or validation reports and deviation assessments. Lead or support change control initiatives, ensuring alignment with regulatory and operational requirements while driving process improvements. Support monitoring initiatives by configuring applicable...Regulatory
Validation & Engineering Group
Puerto Rico10 days ago - ...Job Description Job Description Position Summary The Compliance & AML Analyst supports the Firm in executing its regulatory and supervisory responsibilities. This person reports to the Broker Dealer and RIA Chief Compliance Officers. This role is ideal for a detail...RegulatoryWork at officeLocal area
AGC Consulting
Puerto Rico23 days ago - ...monthly progress reports, risk logs, and executive summaries. Compliance & Quality Oversight Ensure all CQV activities meet regulatory expectations (FDA, EMA), ASTM E2500, ISPE Baseline Guides, and internal procedures. Facilitate deviation management, change...RegulatoryFor contractors
Validation & Engineering Group
Puerto Rico4 days ago - ...support utilities. The successful candidate will collaborate with cross-functional teams and ensure compliance with FDA, EMA, and ICH regulatory requirements throughout the CQV lifecycle. Key Responsibilities: Author, review, and execute commissioning and...Regulatory
Validation & Engineering Group
Puerto Rico4 days ago - ...inspection technologies . This role ensures equipment, control systems, and supporting utilities are qualified in compliance with regulatory standards (FDA, EMA, Annex 1) and ready for GMP use at site start-up. Key Responsibilities Project Leadership & Planning...Regulatory
Validation & Engineering Group
Puerto Rico3 days ago - ...) with excellent oral skills. Must be proficient using MS Windows and Microsoft Office applications. Knowledge in cGxP and regulatory guidance as well as understanding of how they are applied to regulatory compliance. Experience in Commissioning, Qualification...RegulatoryWeekend work
Validation & Engineering Group
Puerto Rico17 days ago - ...Description Job Description Position Summary The Compliance Analyst supports the Compliance Manager in executing the firm’s regulatory and supervisory responsibilities. This person reports to the Compliance Manager and the Chief Compliance Officer. This role is...RegulatoryWork at officeLocal area
AGC Consulting
Puerto Rico7 days ago - ...Qualifications: Bachelor's Degree in Science. Minimum of 8 years of experience in direct pharmaceutical quality control areas and regulatory operations. Must be fully bilingual (English / Spanish) with excellent oral skills. Must be proficient using MS Windows and...RegulatoryWeekend work
Validation & Engineering Group
Puerto Rico4 days ago - ...manufacturing areas. 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. Available to work extended hours, possibility...RegulatoryImmediate startWeekend work
Validation & Engineering Group
Puerto Rico3 days ago - ...involved in manufacturing and distribution, QA, QAL, validation and process development. - Demonstrate ability to interact with regulatory agencies. - Strong word processing, presentation, database and spreadsheet application skills. - Strong communication (both...RegulatoryLocal areaNight shift
Validation & Engineering Group
Puerto Rico12 days ago - ...important technical contributions as part of an extended team. Work cooperatively with R&D, Process Development, Quality, Production, Regulatory, Equipment Engineering, Supply Chain and Marketing to ensure project success. Identifies problems and proposes solutions to...RegulatoryWork experience placement
Validation & Engineering Group
Puerto Rico26 days ago - ...documents across multiple systems. Collaboration & Communication – Serves as a bridge between engineering, quality, and construction teams. GMP Compliance Focus – Understands the criticality of accurate turnover for regulatory approval and operational readiness....Regulatory
Validation & Engineering Group
Puerto Rico17 days ago - ...Validation & Engineering Group, Inc. (V&EG), a Pinnaql Company, is a leading professional services firm that provides engineering and regulatory compliance solutions for the Pharmaceutical, Biotechnology, Chemical, Food, and Medical Devices industries in the following areas...RegulatoryHourly payWork experience placement
Validation & Engineering Group
Puerto Rico21 days ago - ...AutoCAD, Revit, or Plant 3D , and engineering management software. Skills Deep knowledge of GMP, ISPE Baseline Guides, and regulatory requirements. Strong leadership, coordination, and communication skills. Ability to manage multiple technical disciplines...Regulatory
Validation & Engineering Group
Puerto Rico20 days ago - ...validated system state. Support integration and configuration of automation technologies. Document activities per quality and regulatory standards. Provide flexibility to support business demands (overtime, holidays, weekends, or night shifts when required)....RegulatoryNight shiftWeekend work
Validation & Engineering Group
Puerto Rico8 days ago - ...Spanish) with excellent oral skills. Must be proficient using MS Windows and Microsoft Office applications. Strong knowledge in regulatory guidance Experience with Process Engineering and the development and execution of Validation Protocols Technical Writing...RegulatoryWeekend work
Validation & Engineering Group
Puerto Rico6 days ago - ...support for fermentation manufacturing processes , ensuring that production operations run smoothly, safely, and in compliance with regulatory standards. Responsibilities include t roubleshooting, documentation, process improvement, and equipment support....RegulatoryWeekend work
Validation & Engineering Group
Puerto Rico3 days ago
