Integrated Services For Productivity & Validation, Inc

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 author

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 author

Relevant experience in a commercial biopharmaceutical manufacturing environment preferably supporting formulation and aseptic filling operations. Understanding of protein science formulation and filling processes. Experience with process monitoring data trending and statistical analy

Relevant experience in a commercial biopharmaceutical manufacturing environment preferably supporting formulation and aseptic filling operations. Understanding of protein science formulation and filling processes. Experience with process monitoring data trending and statistical analy

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

Added attributes: Excellent mathematics skills Effective written and verbal communications skills Experience with spreadsheets and schedules Proficient in SAP Proficient in Excel Word Power Point Smartsheet and other analytics software Knowledge documenting SOPs deviations and/or CAPA

Added attributes: Excellent mathematics skills Effective written and verbal communications skills Experience with spreadsheets and schedules Proficient in SAP Proficient in Excel Word Power Point Smartsheet and other analytics software Knowledge documenting SOPs deviations and/or CAPA

The candidate should have experience in Quality and Compliance regulatory audits validation characterization automation validation reports. Also reviewing and quality approving of deviations critical utilities and environmental monitoring trend reports.RequirementsDoctorate OR Masters

The candidate should have experience in Quality and Compliance regulatory audits validation characterization automation validation reports. Also reviewing and quality approving of deviations critical utilities and environmental monitoring trend reports.RequirementsDoctorate OR Masters

Experience supporting equipment and system decommissioning projects in a regulated manufacturing environment. Strong knowledge of Good Documentation Practices (GDP). Experience with change control processes and risk assessments. Knowledge of commissioning and decommissioning activiti

Experience supporting equipment and system decommissioning projects in a regulated manufacturing environment. Strong knowledge of Good Documentation Practices (GDP). Experience with change control processes and risk assessments. Knowledge of commissioning and decommissioning activiti

Knowledge in Packaging equipment. Knowledge in Design of new equipment process. Knowledge in Engineering Project Knowledge in Validations Experience in Medical Device or Pharma Bilingual (English/Spanish)RequirementsDoctorate OR Masters 2 years of Engineering experience Alternativel

Knowledge in Packaging equipment. Knowledge in Design of new equipment process. Knowledge in Engineering Project Knowledge in Validations Experience in Medical Device or Pharma Bilingual (English/Spanish)RequirementsDoctorate OR Masters 2 years of Engineering experience Alternativel

Bachelors degree in engineering is a plusDeviations managementDeviation assessmentsTrack wiseBiotech and manufacturing experienceRequirementsDoctorate OR Masters 2 years of Manufacturing Operations experience Alternatively Bachelors 4 years of Manufacturing Operations experience Alt

Bachelors degree in engineering is a plusDeviations managementDeviation assessmentsTrack wiseBiotech and manufacturing experienceRequirementsDoctorate OR Masters 2 years of Manufacturing Operations experience Alternatively Bachelors 4 years of Manufacturing Operations experience Alt

Bachelors degree in engineering is a plusDeviations managementDeviation assessmentsTrack wiseBiotech and manufacturing experienceRequirementsDoctorate OR Masters 2 years of Manufacturing Operations experience OR Bachelors 4 years of Manufacturing Operations experience OR Associates

Bachelors degree in engineering is a plusDeviations managementDeviation assessmentsTrack wiseBiotech and manufacturing experienceRequirementsDoctorate OR Masters 2 years of Manufacturing Operations experience OR Bachelors 4 years of Manufacturing Operations experience OR Associates

Validation experience in highly regulated industry If possible filling validation and work on technical documentation.RequirementsDoctorate PhD OR PharmD OR MDOR -Master 3 years of Scientific experienceOR -Bachelors 5 years of Scientific experience.Science background as Engineering

Validation experience in highly regulated industry If possible filling validation and work on technical documentation.RequirementsDoctorate PhD OR PharmD OR MDOR -Master 3 years of Scientific experienceOR -Bachelors 5 years of Scientific experience.Science background as Engineering

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. Experience authoring

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. Experience authoring

Experience providing Manufacturing support (if vials filling preferred). Experience deploying or integrating AI solutions into manufacturing or operational environments. Artificial intelligence software development and computer literacy knowledge. Hands-on experience developing AI/ML

Experience providing Manufacturing support (if vials filling preferred). Experience deploying or integrating AI solutions into manufacturing or operational environments. Artificial intelligence software development and computer literacy knowledge. Hands-on experience developing AI/ML

Bachelors degree in engineering is a plusDeviations managementDeviation assessmentsTrack wiseBiotech and manufacturing experienceRequirementsDoctorate OR Masters 2 years of Manufacturing Operations experience Alternatively Bachelors 4 years of Manufacturing Operations experience Alt

Bachelors degree in engineering is a plusDeviations managementDeviation assessmentsTrack wiseBiotech and manufacturing experienceRequirementsDoctorate OR Masters 2 years of Manufacturing Operations experience Alternatively Bachelors 4 years of Manufacturing Operations experience Alt

Educational background preferred: Science EngineeringExperience in Manufacturing area working with procedures.CAPA/ CAPA EV Change Control develop new procedures enhance currents process Implement new process modify the current SOPs Provide training to operators.RequirementsDoctorate

Educational background preferred: Science EngineeringExperience in Manufacturing area working with procedures.CAPA/ CAPA EV Change Control develop new procedures enhance currents process Implement new process modify the current SOPs Provide training to operators.RequirementsDoctorate

Experience in drug product manufacturing.Process ValidationWriting technical protocols or reports.RequirementsDoctorate OR Masters 2 years of Scientific experience ORBachelors 4 years of Scientific experience.Preferred: Chemical or Mechanical Engineering preferred but not required.R

Experience in drug product manufacturing.Process ValidationWriting technical protocols or reports.RequirementsDoctorate OR Masters 2 years of Scientific experience ORBachelors 4 years of Scientific experience.Preferred: Chemical or Mechanical Engineering preferred but not required.R

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 e

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 e

Relevant experience in a commercial biopharmaceutical manufacturing environment preferably supporting formulation and aseptic filling operations. Understanding of protein science formulation and filling processes. Experience with process monitoring data trending and statistical analy

Relevant experience in a commercial biopharmaceutical manufacturing environment preferably supporting formulation and aseptic filling operations. Understanding of protein science formulation and filling processes. Experience with process monitoring data trending and statistical analy

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

Specific responsibilities include but are not limited to: Support all phases of inspection project managementfrom planning and implementation to monitoring completion and follow-upensuring alignment with goals timelines and quality standards. Lead PD related Project Management project

Specific responsibilities include but are not limited to: Support all phases of inspection project managementfrom planning and implementation to monitoring completion and follow-upensuring alignment with goals timelines and quality standards. Lead PD related Project Management project

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