Integrated Services For Productivity & Validation, Inc

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

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

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

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

Preferred qualification in experience with Inspection Development process. Basic Knowledge in statistics using Minitab JMP or other statistical software Project Management Skills Knowledge in development documentation protocols and reports Excellent Communication and Teamwork skills

Preferred qualification in experience with Inspection Development process. Basic Knowledge in statistics using Minitab JMP or other statistical software Project Management Skills Knowledge in development documentation protocols and reports Excellent Communication and Teamwork skills

o Experience Working with Clean Utilities Systems such as Distilled Water Purified Water RO System.o Experience working on Clean Gases Process Air GMP gases supply like Oxygen Nitrogeno Experience documenting and managing Deviation non-conformanceo Proficient in GMP documentation and

o Experience Working with Clean Utilities Systems such as Distilled Water Purified Water RO System.o Experience working on Clean Gases Process Air GMP gases supply like Oxygen Nitrogeno Experience documenting and managing Deviation non-conformanceo Proficient in GMP documentation and

Lead cycle development for the E-Beam Isolator SAPA-P and Glove Integrity Tester (GIT)Evaluate cycle development data resultsCoordinate & support equipment characterization and qualification activities.Create characterization protocols data spreadsheets and reports from the Debagger E

Lead cycle development for the E-Beam Isolator SAPA-P and Glove Integrity Tester (GIT)Evaluate cycle development data resultsCoordinate & support equipment characterization and qualification activities.Create characterization protocols data spreadsheets and reports from the Debagger E

Responsible of performing finance partnering activities to support capital site strategy.Responsible for developing implementing and maintaining the financial plans and policies of the capital organization. In charge of establishing fiscal controls preparing financial reports advising

Responsible of performing finance partnering activities to support capital site strategy.Responsible for developing implementing and maintaining the financial plans and policies of the capital organization. In charge of establishing fiscal controls preparing financial reports advising

Bachelors Degree in Engineering preferred Mechanical Electrical or Chemical Excellent written and verbal communication skills Technical writing experience Working knowledge and experience with cGMP procedures and engineering practices on pharmaceutical/biotech production processes fac

Bachelors Degree in Engineering preferred Mechanical Electrical or Chemical Excellent written and verbal communication skills Technical writing experience Working knowledge and experience with cGMP procedures and engineering practices on pharmaceutical/biotech production processes fac

Preferred candidates will have Validation Experience in Parenteral Manufacturing. Specifically experience focused in Aseptic Process Validation Aseptic Techniques Environmental Monitoring Performance Qualifications Environmental Characterizations Airflow Visualization (Smoke Tests). E

Preferred candidates will have Validation Experience in Parenteral Manufacturing. Specifically experience focused in Aseptic Process Validation Aseptic Techniques Environmental Monitoring Performance Qualifications Environmental Characterizations Airflow Visualization (Smoke Tests). E

Preventive Maintenance Execution ExperienceKnowledge Reading Drawing (Electrical/Mechanical)Machine Timing Adjustment ExperienceBasic knowledge in PLC/AutomationHydraulic and Pneumatic System KnowledgeVision System basic KnowledgeRequirementsAssociates and 6 months of maintenance work

Preventive Maintenance Execution ExperienceKnowledge Reading Drawing (Electrical/Mechanical)Machine Timing Adjustment ExperienceBasic knowledge in PLC/AutomationHydraulic and Pneumatic System KnowledgeVision System basic KnowledgeRequirementsAssociates and 6 months of maintenance work

Expericence in Quality and ComplianceExperience with validation protocols and reports for clean utilities manufacturing processes cleaning processes equipment computerized systems change control records deviationsetc. Experience in biological processes is desired.RequirementsDoctorate

Expericence in Quality and ComplianceExperience with validation protocols and reports for clean utilities manufacturing processes cleaning processes equipment computerized systems change control records deviationsetc. Experience in biological processes is desired.RequirementsDoctorate

NPI Change Control Documentation Review Validation C&Q PPQ FATRequirementsDoctorate OR Masters 2 years of directly related experience ORBachelors 4 years of directly related experience ORAssociates 8 years of directly related experience ORHigh school/GED 10 years of directly relat

NPI Change Control Documentation Review Validation C&Q PPQ FATRequirementsDoctorate OR Masters 2 years of directly related experience ORBachelors 4 years of directly related experience ORAssociates 8 years of directly related experience ORHigh school/GED 10 years of directly relat

Change Control Documentation Review Validation PPQRequirementsDoctorate OR Masters 2 years of directly related experience ORBachelors 4 years of directly related experience ORAssociates 8 years of directly related experience ORHigh school/GED 10 years of directly related experienc

Change Control Documentation Review Validation PPQRequirementsDoctorate OR Masters 2 years of directly related experience ORBachelors 4 years of directly related experience ORAssociates 8 years of directly related experience ORHigh school/GED 10 years of directly related experienc

Aseptic Process NPI Change Control FATs Validation and PPQsRequirementsDoctorate OR Masters 2 years of directly related experience ORBachelors 4 years of directly related experience ORAssociates 8 years of directly related experience ORHigh school/GED 10 years of directly related

Aseptic Process NPI Change Control FATs Validation and PPQsRequirementsDoctorate OR Masters 2 years of directly related experience ORBachelors 4 years of directly related experience ORAssociates 8 years of directly related experience ORHigh school/GED 10 years of directly related

Aseptic Process NPI Change Control FATs Validation and PPQsRequirements-Doctorate OR-Masters 2 years of directly related experience OR-Bachelors 4 years of directly related experience OR-Associates 8 years of directly related experience OR-High school/GED 10 years of directly rela

Aseptic Process NPI Change Control FATs Validation and PPQsRequirements-Doctorate OR-Masters 2 years of directly related experience OR-Bachelors 4 years of directly related experience OR-Associates 8 years of directly related experience OR-High school/GED 10 years of directly rela

NPIChange ControlDocumentation ReviewValidationPPQFATRequirementsDoctorate OR Masters 2 years of directly related experience OR Bachelors 4 years of directly related experience ORAssociates 8 years of directly related experience ORHigh school/GED 10 years of directly related exper

NPIChange ControlDocumentation ReviewValidationPPQFATRequirementsDoctorate OR Masters 2 years of directly related experience OR Bachelors 4 years of directly related experience ORAssociates 8 years of directly related experience ORHigh school/GED 10 years of directly related exper

NPI Change ControlFATsValidationPPQsRequirementsDoctorate OR Masters 2 years of directly related experience ORBachelors 4 years of directly related experience ORAssociates 8 years of directly related experience ORHigh school/GED 10 years of directly related experience.Life Science

NPI Change ControlFATsValidationPPQsRequirementsDoctorate OR Masters 2 years of directly related experience ORBachelors 4 years of directly related experience ORAssociates 8 years of directly related experience ORHigh school/GED 10 years of directly related experience.Life Science

Experience with: VeevaTrackwiseCAPAChange ControlRequirementsDoctorate degree OR Masters degree and 3 years of Manufacturing Operations experience ORBachelors degree and 5 years of Manufacturing Operations experience ORAssociates degree and 10 years of Manufacturing Operations experie

Experience with: VeevaTrackwiseCAPAChange ControlRequirementsDoctorate degree OR Masters degree and 3 years of Manufacturing Operations experience ORBachelors degree and 5 years of Manufacturing Operations experience ORAssociates degree and 10 years of Manufacturing Operations experie