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- ...information systems, or a related discipline, or an equivalent combination of education and relevant experience. Experience in aseptic pharmaceutical or biologics manufacturing. Experience serving as a Change Control program owner, coordinator, or committee chair...SuggestedInterim role
Validation & Engineering Group, Inc
Puerto Rico10 days ago - ...strategy presentations. Protocol development: Experienced in designing protocols for complex systems such as filling lines and aseptic processes. Collaboration: Proven experience working with QA, Manufacturing, and Engineering teams during critical activities...SuggestedTemporary workLocal areaShift work
Kelly Services
Puerto Rico23 days ago $20 - $24 per hour
...This position requires knowledge in: quality / compliance management, visual inspection AQL and operator certification processes, aseptic processing operations, as well as regulations and standards affecting Biologics and Parenteral applications. Qualifications :...SuggestedArtech LLC
Puerto Rico3 days ago$36 - $41.43 per hour
...Quality representative to support manufacturing and technical operations for the introduction of new biological products filled under aseptic processing conditions. Required experience in parenteral filling operations for sterile drug products. Knowledgeable in the...SuggestedWork at officeMonday to FridayDay shiftArtech LLC
Puerto Rico3 days ago- ...Instrumentation/ Calibration to manage calibration program. Experience performing calibrations to Bioreactors, Utilities, Formulation, Aseptic Areas. Experience in Blue Mountain (RAM), Calman, or Procal Software is highly preferred. Must possess experience in:...Suggested
MENTOR TECHNICAL GROUP CORP
Puerto Rico7 days ago - ...Instrumentation/ Calibration to manage calibration program. Experience performing calibrations to Bioreactors, Utilities, Formulation, Aseptic Areas. Experience in Blue Mountain (RAM), Calman, or Procal Software is highly preferred. Must possess experience in:...Suggested
MENTOR TECHNICAL GROUP CORP
Puerto Rico7 days ago - ...This position requires knowledge in: quality / compliance management, visual inspection AQL and operator certification processes, aseptic processing operations, as well as regulations and standards affecting Biologics and Parenteral applications. Qualifications : List...SuggestedShift workRotating shiftWeekend work
Artech LLC
Puerto Rico3 days ago - ...Ensure appropriate and correct use of applicable equipment for sample collection and delivery. Apply and assure appropriate aseptic techniques during all sampling activities. Ensure timely approval and reporting of applicable sampling results. Maintain appropriate...Suggested
MENTOR TECHNICAL GROUP CORP
Puerto Rico7 days ago - ...supervisory / managerial position. 4. Proven technical knowledge in Parenteral or Pharmaceutical environmental monitoring program, aseptic operations, isolators, sanitization and sterilization process. 5. Must have knowledge in compendium requirements, cGMP, GLP, and FDA...SuggestedWork at officeShift workRotating shift
MENTOR TECHNICAL GROUP CORP
Puerto Rico7 days ago - ...experience in deviation management, quality assurance, or compliance in FDA-regulated environments. Previous experience working in aseptic processes or sterile manufacturing environments is required. Strong understanding of GMP, FDA regulations, and quality systems....SuggestedShift work
MENTOR TECHNICAL GROUP CORP
Puerto Rico7 days ago - ...areas (e.g., ISO 5–8). • Perform hands-on cleaning activities within cleanroom environments in accordance with cGMPs, SOPs, and aseptic practices. • Support cleaning validation activities, including execution of protocols, sampling activities, and documentation....SuggestedLocal area
Biosimilar Sciences PR LLC
Puerto Rico7 days ago $35 - $39 per hour
...assurance oversight of global engineering programs which may include projects related to biologics (drug substance/drug product), API, aseptic manufacturing, terminally sterilized products, medical devices and laboratories, ensuring quality and GMP requirements are met....SuggestedMonday to Friday- ...contamination control, and continuous improvement. Job Overview The Sterility Assurance Lead is accountable for ensuring that aseptic processing systems and sterility assurance controls are designed, implemented, monitored, and maintained in a validated state of...SuggestedLocal areaFlexible hoursWeekend work
Biosimilar Sciences PR LLC
Puerto Rico7 days ago - ...GMP Environmental Monitoring or Utilities Sampling activities is preferred. Experience in clean room environmental monitoring and aseptic technique is a preferred. Mentor Technical Group es un empleador que ofrece igualdad de oportunidades y todos los solicitantes...Suggested
MENTOR TECHNICAL GROUP CORP
Puerto Rico7 days ago - ...Engineering, Supply Chain, and Validation teams to support successful product introductions. Support transfer and scale-up activities for aseptic filling, formulation, filtration, and related manufacturing processes. Provide technical support for drug substance process...SuggestedWork at officeLocal area
Biosimilar Sciences PR LLC
Puerto Rico7 days ago - ...calibration activities. · Lead, supervise, and develop maintenance and calibration personnel. · Ensure maintenance teams are trained for aseptic interventions, cleanroom entry, gowning, and safety protocols. · Collaborate with Production, Engineering, Supply Chain, and QA...Work at officeLocal area
- ...validation programs and supporting regulatory inspections Technical Expertise Cleanroom and critical utility qualification Aseptic processing and sterilization validation Equipment commissioning and lifecycle validation Risk-based validation (ASTM E2500)...Contract workLocal areaFlexible hoursWeekend work
- ...compliance with cGMP, safety, environmental, and company requirements. • Follow approved SOPs, work instructions, cleanroom gowning, aseptic practices, and safety procedures. • Support deviation investigations, root cause analysis, CAPAs, and change control activities....
- ...Experience supporting sterile drug product manufacturing within the pharmaceutical or biotechnology industry. Hands-on experience with aseptic filling operations, process characterization, process validation (PPQ), technology transfer, and commercial process support....
Validation & Engineering Group, Inc
Puerto Rico9 days ago $106.7k - $123.97k
...fill and compound medications, using standard formulas and processes such as weighing, measuring, mixing ingredients, and sterile aseptic preparation of IV solutions where applicable. Follows established procedures concerning security of controlled substances, prescriptions...Hourly payWork experience placementWork at office- ...people management or team leadership experience Certified Quality Auditor (CQA) or equivalent certification Experience with aseptic processing, drug product/substance, combination products, and data integrity Ability to travel domestically and internationally...Contract work
- ...Automation, and/or Manufacturing leadership experience within complex, highly regulated manufacturing operations, ideally including aseptic Drug Product filling and inspection.Demonstrated success leading large, multidisciplinary technical organizations and developing...Full time
Amgen
Puerto Rico3 days ago
