Integrated Services For Productivity & Validation, Inc

Knowledge in: Environmental Monitoring Microbial Identification (Micro ID) Critical Utilities (CU) monitoring Sampling monitoring: equipment and techniques Data trending and evaluation Microbiological testing methods and standards for clean rooms and controlled environments Aseptic be

Knowledge in: Environmental Monitoring Microbial Identification (Micro ID) Critical Utilities (CU) monitoring Sampling monitoring: equipment and techniques Data trending and evaluation Microbiological testing methods and standards for clean rooms and controlled environments Aseptic be

Experience in parenteral products vision system device assembly and packaging.RequirementsDoctorate OR Masters 2 years of Engineering experience Alternatively Bachelors in engineering 4 years of Engineering experience.Required Skills:Experience in parenteral products vision system d

Experience in parenteral products vision system device assembly and packaging.RequirementsDoctorate OR Masters 2 years of Engineering experience Alternatively Bachelors in engineering 4 years of Engineering experience.Required Skills:Experience in parenteral products vision system d

Execute Quality disposition (approval or rejection) of bulk drug substances. Provide Quality oversight to ensure that operations for clinical and licensed pharmaceutical Drug Substance (API) are manufactured tested stored and managed according to current Good Manufacturing Practices

Execute Quality disposition (approval or rejection) of bulk drug substances. Provide Quality oversight to ensure that operations for clinical and licensed pharmaceutical Drug Substance (API) are manufactured tested stored and managed according to current Good Manufacturing Practices

Process Development Scientist to join the Drug Product Process Development Compliance and Lab Operations Group based in Client sites Juncos facility. The group provides scientific expertise and technical support to Client sites Juncos Drug Product commercial facility while supporting

Process Development Scientist to join the Drug Product Process Development Compliance and Lab Operations Group based in Client sites Juncos facility. The group provides scientific expertise and technical support to Client sites Juncos Drug Product commercial facility while supporting

Familiar with distribution testing per ASTM D4169 International Organization for Standardization (ISO) Technical Association of the Pulp and Paper Industry (TAPPI) United States Pharmacopoeia (USP) and European Pharmacopoeia (EP). Strong knowledge of primary and secondary packaging s

Familiar with distribution testing per ASTM D4169 International Organization for Standardization (ISO) Technical Association of the Pulp and Paper Industry (TAPPI) United States Pharmacopoeia (USP) and European Pharmacopoeia (EP). Strong knowledge of primary and secondary packaging s

MustExperience in Regulated IndustryProficient in creating and executing validation and qualification documentationProvide support to vision inspection qualification and characterizationsPlusA Plus: Knowledge in automated vision inspection systemsA Plus: Knowledgeable in CSV. Support

MustExperience in Regulated IndustryProficient in creating and executing validation and qualification documentationProvide support to vision inspection qualification and characterizationsPlusA Plus: Knowledge in automated vision inspection systemsA Plus: Knowledgeable in CSV. Support

Change Control experience Skills in handling multiple responsibilities priorities tasks and projects simultaneously. Skills in working under time pressure. Practical project management software and spreadsheet skills proficient computer operation skills. Effective interactions in a t

Change Control experience Skills in handling multiple responsibilities priorities tasks and projects simultaneously. Skills in working under time pressure. Practical project management software and spreadsheet skills proficient computer operation skills. Effective interactions in a t

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