Integrated Services For Productivity & Validation, Inc

Experience preparing syringes and vials with cosmetic particle or solution defects for developmental studies equipment characterization training activities and commercial equipment setup. Experience using laboratory equipment and instruments including calipers microscopes and analyti

Experience preparing syringes and vials with cosmetic particle or solution defects for developmental studies equipment characterization training activities and commercial equipment setup. Experience using laboratory equipment and instruments including calipers microscopes and analyti

Provides engineering support for the operation troubleshooting optimization and modification of HVAC utilities and facility systems within a regulated pharmaceutical/biotech environment. Applies engineering principles to resolve operational issues support preventive maintenance strate

Provides engineering support for the operation troubleshooting optimization and modification of HVAC utilities and facility systems within a regulated pharmaceutical/biotech environment. Applies engineering principles to resolve operational issues support preventive maintenance strate

Manufacturing ExperienceOn the floor support to Assess process performance by observation of floor operations and review of performance data.Initiate revise and approve manufacturing procedures.Provide process troubleshooting support.Participate in the NPI process to assess requiremen

Manufacturing ExperienceOn the floor support to Assess process performance by observation of floor operations and review of performance data.Initiate revise and approve manufacturing procedures.Provide process troubleshooting support.Participate in the NPI process to assess requiremen

NPIChange ControlFATsValidationPPQsRequirements-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 related experience.Required

NPIChange ControlFATsValidationPPQsRequirements-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 related experience.Required

CAPARisk AssessmentsDOC editorRequirementsDoctorate 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 experience ORHigh school d

CAPARisk AssessmentsDOC editorRequirementsDoctorate 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 experience ORHigh school d

Statistical Analyses experience Experience in Biotech companies would be a plus Drug substance manufacturing/technical support would be a plusRequirementsMasters degree OR Bachelors degree in Engineering & 2 years of Engineering experience. Preferred background: Chemical EngineeringB

Statistical Analyses experience Experience in Biotech companies would be a plus Drug substance manufacturing/technical support would be a plusRequirementsMasters degree OR Bachelors degree in Engineering & 2 years of Engineering experience. Preferred background: Chemical EngineeringB

Work experience in programming coding system design and architecture algorithms and data structures Experience with statistical software coding languages (e.g. R MATLAB SAS Python) and database languages (e.g. SQL) Experience articulating business questions and using programming tech

Work experience in programming coding system design and architecture algorithms and data structures Experience with statistical software coding languages (e.g. R MATLAB SAS Python) and database languages (e.g. SQL) Experience articulating business questions and using programming tech

GxP Documentation Basic Calibration of Temperature Pressure Level and Analytical InstrumentationSanitary Diaphragms and Gaskets replacement skillsAutoclave/Glasswasher skillsMaximo CMMS DocumentationTechnical Documentation skillsLock Out/Tag Out (LOTO) skillsRequirements Associates an

GxP Documentation Basic Calibration of Temperature Pressure Level and Analytical InstrumentationSanitary Diaphragms and Gaskets replacement skillsAutoclave/Glasswasher skillsMaximo CMMS DocumentationTechnical Documentation skillsLock Out/Tag Out (LOTO) skillsRequirements Associates an

Manufacturing Experience-On the floor support to Assess process performance by observation of floor operations and review of performance data.-Initiate revise and approve manufacturing procedures.-Provide process troubleshooting support.-Participate in the NPI process to assess requir

Manufacturing Experience-On the floor support to Assess process performance by observation of floor operations and review of performance data.-Initiate revise and approve manufacturing procedures.-Provide process troubleshooting support.-Participate in the NPI process to assess requir

Preferred candidates will have GMP manufacturing experience in Quality Assurance including review and approval of change controls deviations CAPAs protocols reports and procedures. Experience supporting packaging/inspection operations strong knowledge of GDP and electronic quality sys

Preferred candidates will have GMP manufacturing experience in Quality Assurance including review and approval of change controls deviations CAPAs protocols reports and procedures. Experience supporting packaging/inspection operations strong knowledge of GDP and electronic quality sys

This role the resources will provide technical engineering support to continuous daily operations by performing troubleshooting activities process optimization strategies upgrades replacements and modifications to the process or equipment in the manufacturing operations.Ensure that al

This role the resources will provide technical engineering support to continuous daily operations by performing troubleshooting activities process optimization strategies upgrades replacements and modifications to the process or equipment in the manufacturing operations.Ensure that al

Experience in Commissioning and Qualification of parenteral products vision system device assembly and packaging (Automatic and HMLV lines).Requirements-Doctorate OR Masters 2 years of Engineering experience OR-Bachelors in Engineering 4 years of Engineering experience.Required Skil

Experience in Commissioning and Qualification of parenteral products vision system device assembly and packaging (Automatic and HMLV lines).Requirements-Doctorate OR Masters 2 years of Engineering experience OR-Bachelors in Engineering 4 years of Engineering experience.Required Skil

Bachelors or higher degree in Environmental Health & Safety or related technical field preferred. Professional certifications such as CSP ASP and OSHA certifications are not required but are highly preferred and considered for this role. Knowledge of EH&S regulations industry standar

Bachelors or higher degree in Environmental Health & Safety or related technical field preferred. Professional certifications such as CSP ASP and OSHA certifications are not required but are highly preferred and considered for this role. Knowledge of EH&S regulations industry standar

General packaging/engineering experience in final product manufacturing within the Pharma/Biotech Industry. Excellent understanding of Good Manufacturing Practices (GMP) and Good Documentation Practices (GDP). Strong knowledge of common materials used in pharmaceutical primary and se

General packaging/engineering experience in final product manufacturing within the Pharma/Biotech Industry. Excellent understanding of Good Manufacturing Practices (GMP) and Good Documentation Practices (GDP). Strong knowledge of common materials used in pharmaceutical primary and se

Experience in project management root cause analysis CAPA determination.Quality mindset and deep compliance knowledge.Proficient in Microsoft Office Programs (Excel Outlook) and usage of Teams.Requirements-Doctorate OR Masters 2 years of directly related experience OR-Bachelors 4 ye

Experience in project management root cause analysis CAPA determination.Quality mindset and deep compliance knowledge.Proficient in Microsoft Office Programs (Excel Outlook) and usage of Teams.Requirements-Doctorate OR Masters 2 years of directly related experience OR-Bachelors 4 ye

This role will serve as the External Supply Quality Record Owner responsible for managing and executing supplier-related Change Control quality records with minimal supervision. The individual will lead cross-functional meetings to ensure the timely progression and closure of Change C

This role will serve as the External Supply Quality Record Owner responsible for managing and executing supplier-related Change Control quality records with minimal supervision. The individual will lead cross-functional meetings to ensure the timely progression and closure of Change C

System Owner Experience- MMP experience Working knowledge and experience with cGMP procedures and engineering practices on pharmaceutical/biotech production processes facilities and equipment. Experience with Maximo Capable of working and/or submitting Purchase Orders (PO) Experience

System Owner Experience- MMP experience Working knowledge and experience with cGMP procedures and engineering practices on pharmaceutical/biotech production processes facilities and equipment. Experience with Maximo Capable of working and/or submitting Purchase Orders (PO) Experience

Experience in biotechnology processes specifically in purification operations.Knowledge in chromatography and UFDF techniquesRequirementsMasters degree OR Bachelors degree in Engineering & 2 years of Engineering experienceShift: 8am a 5PMRequired Skills: Experience in biotechnology pr

Experience in biotechnology processes specifically in purification operations.Knowledge in chromatography and UFDF techniquesRequirementsMasters degree OR Bachelors degree in Engineering & 2 years of Engineering experienceShift: 8am a 5PMRequired Skills: Experience in biotechnology pr

EW Specialist QA Job Description: SPECIFIC RESPONSIBILITIES INCLUDE BUT ARE NOT LIMITED TO: Perform On-the-floor Plant Quality Assurance (PQA) review approval and tracking of cGMP processes procedures testing methods in manufacturing documents and records batch record review MES EBR

EW Specialist QA Job Description: SPECIFIC RESPONSIBILITIES INCLUDE BUT ARE NOT LIMITED TO: Perform On-the-floor Plant Quality Assurance (PQA) review approval and tracking of cGMP processes procedures testing methods in manufacturing documents and records batch record review MES EBR

. 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 manufacturin

. 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 manufacturin