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- ...to support phased appropriate development for early development, pre-clinical, clinical, and commercial start. We behave more like a cGMP incubator space with all regulatory, systems capabilities, and resources to enable CMC data to support regulatory applications....SuggestedFull timeLocal areaRelocation
Biosimilar Sciences PR LLC
Puerto Rico6 days ago - ...integrity principles, risk-based qualification and validation, and industry standards relevant to the assigned scope, including FDA cGMP requirements and, as applicable, EU GMP Annex 1, 21 CFR Part 11, and ISPE/GAMP principles. Ability to exercise independent QA judgment...SuggestedInterim role
Validation & Engineering Group, Inc
Puerto Rico9 days ago - ...minimal supervision. Responsibilities : Perform On-the-floor Plant Quality Assurance (PQA) review, approval, and tracking of cGMP processes, procedures, testing methods in manufacturing, documents and records, batch record review, MES, EBR, SAP, EDMQ, DQMS, Trackwise...SuggestedFor contractorsLocal areaShift work
ECHO Consulting Group
Puerto Rico22 days ago - ...company values and ethical behavior in all relationships with internal and external customers. Strictly follow company's Safety, cGMP's, Policies and Procedures. Other duties as assigned by manager, upper management or by the client to support normal operations....SuggestedContract workFor contractorsLocal area
$18 - $22 per hour
...written policies and procedures and, in addition, complying with regulations applicable to our industry (National Electric Code, NFPA70E, cGMP, FDA, OSHA, etc.), operational manuals, specifications and drawings while maintaining a high degree of reliability in a safe and...SuggestedContract workLocal areaShift workNight shiftWeekend workDay shiftArtech LLC
Puerto Rico2 days ago$38 - $41.43 per hour
...to raw material specification, product specification, test methods, supplier change notification, shipping, are in compliance with cGMP, policies, regulatory approvals, and Quality Technical Agreement with TPM site. Review and approve manufacturing directions to the...SuggestedLocal areaRemote workMonday to FridayArtech LLC
Puerto Rico2 days ago- ...Temperature Technologies Pressure Humidity Flow Mass PH Conductivity Dimension and Electrical Knowledge in cGMP Associate degree in Instrumentation Engineering Qualifications Requirements/Knowledge/Education/Skills: AD,...Suggested
MENTOR TECHNICAL GROUP CORP
Puerto Rico6 days ago - ...Temperature Technologies Pressure Humidity Flow Mass PH Conductivity Dimension and Electrical Knowledge in cGMP Associate degree in Instrumentation Engineering Qualifications Requirements/Knowledge/Education/Skills: AD,...Suggested
MENTOR TECHNICAL GROUP CORP
Puerto Rico6 days ago $25 - $27.48 per hour
...coordination and leading of local Change Plan, support in complaint investigations, quality improvement programs, and assurance of cGMP and Clients policy compliance for the manufacturing plant. Understands internal business process, to make appropriate prioritization...SuggestedFor contractorsLocal areaImmediate startArtech LLC
Puerto Rico2 days ago- ...policies, and procedures, including safety procedures and the maintenance of a clean work area. ~ Strictly follow company’s safety and cGMP policies and procedures. Perform additional duties as assigned by direct supervisor to support normal operations....SuggestedImmediate startWeekend work
MENTOR TECHNICAL GROUP CORP
Puerto Rico6 days ago - ...oversight to GMP manufacturing operations. Adhere to Standard Operating Procedures (SOPs) and current Good Manufacturing Practices (cGMP). Serve as a reviewer of GMP and quality-related SOPs, as applicable. Provide QA assistance and feedback to utilities and...Suggested
MENTOR TECHNICAL GROUP CORP
Puerto Rico6 days ago - ...program, aseptic operations, isolators, sanitization and sterilization process. 5. Must have knowledge in compendium requirements, cGMP, GLP, and FDA regulations and the ability to interpret and apply them. 6. Fully bilingual (Spanish/English) communication skills, both...SuggestedWork at officeShift workRotating shift
MENTOR TECHNICAL GROUP CORP
Puerto Rico6 days ago - ...the design, implementation, integration, troubleshooting, and validation of robotic and automated material handling systems within a cGMP pharmaceutical manufacturing environment. You will own the end-to-end technical strategy for robotics and ASRS capabilities,...SuggestedWork at office
JC Automation Corp
Puerto Rico6 days ago - ...to support phased appropriate development for early development, pre-clinical, clinical, and commercial start. We behave more like a cGMP incubator space with all regulatory, systems capabilities, and resources to enable CMC data to support regulatory applications. We...SuggestedFor contractors
Biosimilar Sciences PR LLC
Puerto Rico6 days ago - ...Documentation: Document all test results, protocols, and execution records in strict compliance with applicable Good Manufacturing Practices (cGMP) and ALCOA data integrity expectations. Turnover & Documentation Review: Support the collection, review, organization, and...SuggestedFull timeContract work
- ...integrity principles, risk-based qualification and validation, and industry standards relevant to the assigned scope, including FDA cGMP requirements and, as applicable, EU GMP Annex 1, 21 CFR Part 11, and ISPE/GAMP principles. Ability to interpret User Requirements...Remote work
Validation & Engineering Group, Inc
Puerto Rico7 days ago - ...similar chemical, manufacturing, medical device, or pharmaceutical position preferred. Knowledge of Good Manufacturing Practices ( GMP/cGMP ) and safety procedures preferred. Ability to accurately follow manufacturing instructions, procedures, and production...Weekly payFull timeTemporary workLocal areaShift work
Kelly Services
Puerto Rico28 days ago - ...reliability of manufacturing and utilities automation systems, including PLCs, SCADA, DCS, and networked manufacturing equipment, within a cGMP pharmaceutical environment. You will work as part of the site automation team, responding to incidents, executing preventive...Work at officeShift workNight shift
- ...Supervise and coordinate work activities of workers engaged in drafting and designing layouts. ~Strictly follow company’s safety and cGMP policies and procedures. ~ Perform additional duties as assigned by direct supervisor to support normal operations....For contractors
MENTOR TECHNICAL GROUP CORP
Puerto Rico6 days ago $50 - $55 per hour
...including FRS, design specifications, SOPs, validation deliverables, and system records. - Support Data Integrity, FDA 21 CFR Part 11, cGMP, and OT Cybersecurity initiatives across automation and computerized systems. - Collaborate with Engineering, Manufacturing, IT,...Hourly payTemporary work- ...integrity principles, risk-based qualification and validation, and industry standards relevant to the assigned scope, including FDA cGMP requirements and, as applicable, EU GMP Annex 1, 21 CFR Part 11, and ISPE/GAMP principles. Ability to interpret User Requirements...
Validation & Engineering Group, Inc
Puerto Rico9 days ago - ...Responsible for developing and optimizing processes and resolving operational challenges related to lab construction and fit-outs in cGMP-regulated environments. Applies advanced and diverse engineering principles to the design and implementation of lab facility...For contractorsLocal areaShift work
- ...this role, you will serve as the subject matter expert for eBR system design, configuration, troubleshooting, and validation within a cGMP-regulated pharmaceutical manufacturing environment. You will collaborate with Manufacturing, Quality, IT, and Engineering teams...Work at office
- ...Validation, Quality, Process Development, and external vendors to obtain, evaluate, and validate technical information. Applying cGMP requirements to ensure technical assessments are complete, traceable, inspection-ready, and supported by objective evidence....Contract workFor contractorsShift workWeekend work
- ...Aguadilla, Puerto Rico 00603 About OcyonBio OcyonBio is a biotechnology company based in Aguadilla, Puerto Rico, providing flexible cGMP manufacturing spaces and integrated quality and technical services to support the development, manufacture, and commercialization of...Local areaFlexible hoursWeekend work
Biosimilar Sciences PR LLC
Puerto Rico6 days ago - ...to support phased appropriate development for early development, pre-clinical, clinical, and commercial start. We behave more like a cGMP incubator space with all regulatory, systems capabilities, and resources to enable CMC data to support regulatory applications....Local area
Biosimilar Sciences PR LLC
Puerto Rico6 days ago $45 - $47 per hour
...engineering resources on new installations/systems to ensure that factory/site/commissioning documentation is in accordance with cGMP and supports validation. "May supervise contract validation resources in the timely completion of activities in his/her area of...Contract work- ...assure minimal impact to production while aligning with Standard Operating Procedure's (SOP's), Current Good Manufacturing Practices (cGMP's) and client/site facilities regulations. You will be asked also to perform housekeeping activities such as keep clearing work...Work at officeAll shiftsShift workWeekend work
- ...from project inception through completion. Application of engineering principles and methodologies to project and support work. cGMP and regulatory compliance in design and construction activities. Coordination and review of A&E firm design deliverables (...Contract workLocal area
- ...implement policies and procedures. Ensure all necessary testing is carried out and in accordance with internal procedures, protocols, and cGMP's. # Conduct performance evaluations for the assigned EM and Sampling Technicians. # Ensure strict adherence to current Good...
MENTOR TECHNICAL GROUP CORP
Puerto Rico6 days ago
