Integrated Services For Productivity & Validation, Inc

Experience with automated inspection systems development and implementation. Hands-on experience developing AI/ML models for image analysis defect detection classification or process optimization. Experience with Computer Vision technologies and industrial camera systems. Knowledge o

Experience with automated inspection systems development and implementation. Hands-on experience developing AI/ML models for image analysis defect detection classification or process optimization. Experience with Computer Vision technologies and industrial camera systems. Knowledge o

Experience in handling deviations/non-conformances investigations.Skills for technical writing and development of reports.Knowledge and experience with root cause analysis tools (e.g. causal factors analysis 5 Whys).Project management skills on identifying/tracking actions and achievi

Experience in handling deviations/non-conformances investigations.Skills for technical writing and development of reports.Knowledge and experience with root cause analysis tools (e.g. causal factors analysis 5 Whys).Project management skills on identifying/tracking actions and achievi

Extensive experience in process development or manufacturing support within biotech biopharma or related industries. Strong ability to analyze and interpret complex process and experimental data to drive process understanding and optimization. Experience supporting process scale-up t

Extensive experience in process development or manufacturing support within biotech biopharma or related industries. Strong ability to analyze and interpret complex process and experimental data to drive process understanding and optimization. Experience supporting process scale-up t

Excellent written and verbal communication skills Technical writing experience Working knowledge and experience with cGMP procedures and engineering practices on pharmaceutical/biotech production processes facilities and equipment. Experience with QRAES Change cControl non conformanc

Excellent written and verbal communication skills Technical writing experience Working knowledge and experience with cGMP procedures and engineering practices on pharmaceutical/biotech production processes facilities and equipment. Experience with QRAES Change cControl non conformanc

Experience or knowledge in Fermentation Cell Culture or Harvest process is preferred. Also experience supporting commercial campaigns is preferred. Fermentation Cell Culture HarvestRequirementsMasters degree OR Bachelors degree in Engineering & 2 years of Engineering ex

Experience or knowledge in Fermentation Cell Culture or Harvest process is preferred. Also experience supporting commercial campaigns is preferred. Fermentation Cell Culture HarvestRequirementsMasters degree OR Bachelors degree in Engineering & 2 years of Engineering ex

Deviations documentation and Change Control Management.RequirementsDoctorate OR Masters 2 years of Manufacturing Operations experience Alternatively Bachelors 4 years of Manufacturing Operations experience Alternatively Associates 8 years of Manufacturing Operations experience Alte

Deviations documentation and Change Control Management.RequirementsDoctorate OR Masters 2 years of Manufacturing Operations experience Alternatively Bachelors 4 years of Manufacturing Operations experience Alternatively Associates 8 years of Manufacturing Operations experience Alte

1. C&Q Strategy & Planning Develop and implement the overall Commissioning & Qualification strategy aligned with project and regulatory requirements. Define system boundaries and identify direct/indirect impact systems. Lead risk assessments (e.g. ISPE Baseline ASTM E2500) to determin

1. C&Q Strategy & Planning Develop and implement the overall Commissioning & Qualification strategy aligned with project and regulatory requirements. Define system boundaries and identify direct/indirect impact systems. Lead risk assessments (e.g. ISPE Baseline ASTM E2500) to determin

Proficient in creating and executing validation and qualification documentation Provide support to vision inspection qualification and characterizations Requires excellent communication skills with suppliers and other sites A Plus: Knowledge in automated vision inspection systems A P

Proficient in creating and executing validation and qualification documentation Provide support to vision inspection qualification and characterizations Requires excellent communication skills with suppliers and other sites A Plus: Knowledge in automated vision inspection systems A P

Experience in the Manufacturing area specifically writing procedures managing documents in management system (document workflow)RequirementsDoctorate degree OR Masters degree and 3 years of Manufacturing Operations experience Alternatively Bachelors degree and 5 years of Manufacturing

Experience in the Manufacturing area specifically writing procedures managing documents in management system (document workflow)RequirementsDoctorate degree OR Masters degree and 3 years of Manufacturing Operations experience Alternatively Bachelors degree and 5 years of Manufacturing

Quality Professional with experience in Quality System and addition some knowledge or to be familiar with in PASx/MES application MAXIMO SAP LIMS QMTS and Veeva. Available during weekends and holidays as requested always available to be on site. RequirementsDoctorate OR Masters 2 ye

Quality Professional with experience in Quality System and addition some knowledge or to be familiar with in PASx/MES application MAXIMO SAP LIMS QMTS and Veeva. Available during weekends and holidays as requested always available to be on site. RequirementsDoctorate OR Masters 2 ye

Knowledge and experience in: Process Safety Pre-Start Up Safety Reviews Process Safety Management (PSM) High Risk Processes Hazardous/Compressed Gases Combustible Dust Risk Assessments and Machine Safeguards.RequirementsMaster degree or Bachelor degree & 2 years of directly related ex

Knowledge and experience in: Process Safety Pre-Start Up Safety Reviews Process Safety Management (PSM) High Risk Processes Hazardous/Compressed Gases Combustible Dust Risk Assessments and Machine Safeguards.RequirementsMaster degree or Bachelor degree & 2 years of directly related ex

Deviations documentation and Change Control Management.Requirements-Doctorate OR-Masters 2 years of Manufacturing Operations experience OR-Bachelors 4 years of Manufacturing Operations experience OR-Associates 8 years of Manufacturing Operations experience OR-High school/GED 10 ye

Deviations documentation and Change Control Management.Requirements-Doctorate OR-Masters 2 years of Manufacturing Operations experience OR-Bachelors 4 years of Manufacturing Operations experience OR-Associates 8 years of Manufacturing Operations experience OR-High school/GED 10 ye

Manufacturing Equipment ownership at CMMS system (Work orders approval closing PM strategy spare parts definition/accuracy/updates) reliability and change control assessments and requirements. Collaborate with Engineering Staff to ensure the best maintenance strategy on manufacturing

Manufacturing Equipment ownership at CMMS system (Work orders approval closing PM strategy spare parts definition/accuracy/updates) reliability and change control assessments and requirements. Collaborate with Engineering Staff to ensure the best maintenance strategy on manufacturing

Experience in data analysis.Optional knowledge of aseptic operation (filling and support).Recommended experience in engineering reliability elements and process excellence.Recommended experience in maintenance systems and asset management.RequirementsMasters degree OR Bachelors degree

Experience in data analysis.Optional knowledge of aseptic operation (filling and support).Recommended experience in engineering reliability elements and process excellence.Recommended experience in maintenance systems and asset management.RequirementsMasters degree OR Bachelors degree

Engineer with years of experience preferably in aseptic processing environments including Fill/Finish operations such as vial and syringe filling lines. Experience in characterization activities and performance qualification (PQ) for New Product Introductions (NPI).RequirementsDoctora

Engineer with years of experience preferably in aseptic processing environments including Fill/Finish operations such as vial and syringe filling lines. Experience in characterization activities and performance qualification (PQ) for New Product Introductions (NPI).RequirementsDoctora

Scientific Data Analysis Strong Technical Writing (English and Spanish) mainly focuses Strong knowledge in Microsoft Excel as a Tool for Data Analysis Good Communication skills Project Management Sample Management Knowledge in Computer System and Method Validation (Experience prefera

Scientific Data Analysis Strong Technical Writing (English and Spanish) mainly focuses Strong knowledge in Microsoft Excel as a Tool for Data Analysis Good Communication skills Project Management Sample Management Knowledge in Computer System and Method Validation (Experience prefera

o Laboratory Equipment Validationo Periodic Monitoringo Periodic Reviewo Equipment Data Integrityo Equipment Procuremento Decommissioning processo New equipment Introduction and Maintenanceo Others:Biochemistry (eg. Compendial testing physical methods)High-Performance Liquid Chromatog

o Laboratory Equipment Validationo Periodic Monitoringo Periodic Reviewo Equipment Data Integrityo Equipment Procuremento Decommissioning processo New equipment Introduction and Maintenanceo Others:Biochemistry (eg. Compendial testing physical methods)High-Performance Liquid Chromatog

Experience (manufacturing process development or quality assurance) in Biotech or pharmaceutical industry with progressively increasing responsibility and demonstrated experience in compliance problem solving critical thinking project management and quality systems. Proficient and ex

Experience (manufacturing process development or quality assurance) in Biotech or pharmaceutical industry with progressively increasing responsibility and demonstrated experience in compliance problem solving critical thinking project management and quality systems. Proficient and ex