Integrated Services For Productivity & Validation, Inc

Experience of bio-processing unit operationsKnowledge in Root Cause Analysis methodologies (Fishbone Six Boxes Fishbone 5 Whys Kepner Tregoe)Familiar with Lean Manufacturing PracticesAbility to communicate and collaborate with technical and management staff within manufacturing proces

Experience of bio-processing unit operationsKnowledge in Root Cause Analysis methodologies (Fishbone Six Boxes Fishbone 5 Whys Kepner Tregoe)Familiar with Lean Manufacturing PracticesAbility to communicate and collaborate with technical and management staff within manufacturing proces

Preferred experience in Packaging Area.Knowledge in equipment characterization/validation Vision system (inspection system analysis).RequirementsDoctorate OR Masters 2 years of Engineering experience Alternatively Bachelors in Engineering 4 years of Engineering experience8hrs shift

Preferred experience in Packaging Area.Knowledge in equipment characterization/validation Vision system (inspection system analysis).RequirementsDoctorate OR Masters 2 years of Engineering experience Alternatively Bachelors in Engineering 4 years of Engineering experience8hrs shift

Educational background in Mechanical Electrical Industrial and/or Chemical Engineering Experience with equipment and/or process troubleshooting in a regulated environment. Knowledge of pharmaceutical/biotech processes and GMP production operations. Organizational & technical writing

Educational background in Mechanical Electrical Industrial and/or Chemical Engineering Experience with equipment and/or process troubleshooting in a regulated environment. Knowledge of pharmaceutical/biotech processes and GMP production operations. Organizational & technical writing

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

Experience in C&Q process Validation and Packaging.RequirementsDoctorate OR Masters 2 years of Engineering experience OR Bachelors in engineering 4 years of Engineering experience.Preferred: Bachelors in engineering 4 years of Engineering experience.Required Skills:Experience in C&

Experience in C&Q process Validation and Packaging.RequirementsDoctorate OR Masters 2 years of Engineering experience OR Bachelors in engineering 4 years of Engineering experience.Preferred: Bachelors in engineering 4 years of Engineering experience.Required Skills:Experience in C&

Experience in project management Root cause analysis CAPAs determination. Quality mind set and deep compliance knowledge. Proficient in Microsoft Office Program (Excel outlook) usage of MS Teams and proficient in Artificial intelligence programs (ChatGPT).RequirementsDoctorate OR Mast

Experience in project management Root cause analysis CAPAs determination. Quality mind set and deep compliance knowledge. Proficient in Microsoft Office Program (Excel outlook) usage of MS Teams and proficient in Artificial intelligence programs (ChatGPT).RequirementsDoctorate OR Mast

Specific responsibilities include but are not limited to: Own change controls for manufacturing process changes Support major/trend deviation investigations throughout the whole lifecycle including Root Cause Analysis investigation determination of Corrective/Preventive Actions auth

Specific responsibilities include but are not limited to: Own change controls for manufacturing process changes Support major/trend deviation investigations throughout the whole lifecycle including Root Cause Analysis investigation determination of Corrective/Preventive Actions auth

Specific responsibilities include but are not limited to: Own change controls for manufacturing process changes Support major/trend deviation investigations throughout the whole lifecycle including Root Cause Analysis investigation determination of Corrective/Preventive Actions autho

Specific responsibilities include but are not limited to: Own change controls for manufacturing process changes Support major/trend deviation investigations throughout the whole lifecycle including Root Cause Analysis investigation determination of Corrective/Preventive Actions autho

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