Integrated Services For Productivity & Validation, Inc

Specific responsibilities include but are not limited to: Provide solutions to a variety of technical problems of moderate scope and complexity. Under general supervision will evaluate select and apply standard engineering techniques basic principles and procedures. Assistance given f

Specific responsibilities include but are not limited to: Provide solutions to a variety of technical problems of moderate scope and complexity. Under general supervision will evaluate select and apply standard engineering techniques basic principles and procedures. Assistance given f

The candidate should poses a BS in Science Engineering Physics Biology Chemistry or related fields. It should have experienced working in the pharmaceutical industry quality organization supporting deviations validation reports qualifications investigations at least 5 years of experie

The candidate should poses a BS in Science Engineering Physics Biology Chemistry or related fields. It should have experienced working in the pharmaceutical industry quality organization supporting deviations validation reports qualifications investigations at least 5 years of experie

Experience in the inspection (manual/automatic) packaging area incoming (primary containers) Process Development LabWilling to work in a Process Development laboratory environment.RequirementsDoctorate OR Master 2 years of Scientific experience ORBachelors 4 years of Scientific expe

Experience in the inspection (manual/automatic) packaging area incoming (primary containers) Process Development LabWilling to work in a Process Development laboratory environment.RequirementsDoctorate OR Master 2 years of Scientific experience ORBachelors 4 years of Scientific expe

o Knowledge in document handling on Veeva Vault (CDOCs) or similar platformso Technical writing expertiseo Change control handling (owner)o Project handlingo Use of Smartsheet or similar platformRequirementsDoctorate OR Masters 2 years of Manufacturing Operations experience ORBachelo

o Knowledge in document handling on Veeva Vault (CDOCs) or similar platformso Technical writing expertiseo Change control handling (owner)o Project handlingo Use of Smartsheet or similar platformRequirementsDoctorate OR Masters 2 years of Manufacturing Operations experience ORBachelo

Experience in biotechnology processes specifically in purification operations.Knowledge in chromatography and UFDF techniques.RequirementsMasters degree OR Bachelors degree in Engineering & 2 years of Engineering experienceRequired Skills:Experience in biotechnology processes specific

Experience in biotechnology processes specifically in purification operations.Knowledge in chromatography and UFDF techniques.RequirementsMasters degree OR Bachelors degree in Engineering & 2 years of Engineering experienceRequired Skills:Experience in biotechnology processes specific

Quality Professional with Validations and Commissioning & Qualifications of manufacturing equipment and laboratory bench equipment experience (IOQ PQ Functional Test). In addition to Technical Writing Quality Systems (Deviations Change Control) and Maintenance (PM Work Orders Job Plan

Quality Professional with Validations and Commissioning & Qualifications of manufacturing equipment and laboratory bench equipment experience (IOQ PQ Functional Test). In addition to Technical Writing Quality Systems (Deviations Change Control) and Maintenance (PM Work Orders Job Plan

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

-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

Engineering Experience in Manufacturing Operations Hands-on experience in process engineering manufacturing support or production systems within a regulated environment (biotech pharmaceutical or similar).Technical Knowledge Familiarity with automation systems process equipment and

Engineering Experience in Manufacturing Operations Hands-on experience in process engineering manufacturing support or production systems within a regulated environment (biotech pharmaceutical or similar).Technical Knowledge Familiarity with automation systems process equipment and

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

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

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

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

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

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

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