Integrated Services For Productivity & Validation, Inc

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

In this vital role you will provide technical engineering support to continuous daily operations by performing troubleshooting activities process optimization strategiesupgrades replacements and modifications to the process or equipment in the manufacturing operations.Ensure that all

In this vital role you will provide technical engineering support to continuous daily operations by performing troubleshooting activities process optimization strategiesupgrades replacements and modifications to the process or equipment in the manufacturing operations.Ensure that all

Experience working in a GMP-regulated environment within the pharmaceutical medical device or biotechnology industryProficiency in technical report writingEffective communication skills in both Spanish and English (verbal and written)Familiarity with packaging equipment process charac

Experience working in a GMP-regulated environment within the pharmaceutical medical device or biotechnology industryProficiency in technical report writingEffective communication skills in both Spanish and English (verbal and written)Familiarity with packaging equipment process charac

1. Direct experience providing technical or process-development support to commercial pharmaceutical biotechnology medical-device or combination-product manufacturing operations.2. Experience managing projects3. Experience with sterile injectable products prefilled syringes auto injec

1. Direct experience providing technical or process-development support to commercial pharmaceutical biotechnology medical-device or combination-product manufacturing operations.2. Experience managing projects3. Experience with sterile injectable products prefilled syringes auto injec

Preferred qualifications include experience with data analysis dashboard development statistical evaluation GMP documentation validation principles and process improvement. A standout candidate would have working knowledge of AI-enabled or automation tools such as Python Codex Power A

Preferred qualifications include experience with data analysis dashboard development statistical evaluation GMP documentation validation principles and process improvement. A standout candidate would have working knowledge of AI-enabled or automation tools such as Python Codex Power A

Facilities and Utilities Commissioning and QualificationComputer System ValidationEquipment validationRisk AssessmentsKNEATCDOCS SCADA TRACKWISEMAXIMOGood Documentation Practices Data IntegrityChange ControlsStandard Operation ProcedureSyringe/Vials Inspection ProcessDocuments revisio

Facilities and Utilities Commissioning and QualificationComputer System ValidationEquipment validationRisk AssessmentsKNEATCDOCS SCADA TRACKWISEMAXIMOGood Documentation Practices Data IntegrityChange ControlsStandard Operation ProcedureSyringe/Vials Inspection ProcessDocuments revisio

Experience in recipe entry in packaging equipment automation assessment to determine the correct parameter for the recipe and experience in Systech SystemRequirementsMasters degree OR Bachelors degree and 2 years of Engineering experience ORAssociates degree and 6 years of Engineering

Experience in recipe entry in packaging equipment automation assessment to determine the correct parameter for the recipe and experience in Systech SystemRequirementsMasters degree OR Bachelors degree and 2 years of Engineering experience ORAssociates degree and 6 years of Engineering

Previous experience in change control management project controls and capital projects. Demonstrated experience leading New Product Introduction (NPI) technology transfer process development lifecycle management or commercialization programs. Proven ability to lead complex cross-funct

Previous experience in change control management project controls and capital projects. Demonstrated experience leading New Product Introduction (NPI) technology transfer process development lifecycle management or commercialization programs. Proven ability to lead complex cross-funct

Strong knowledge and demonstrated experience with Quality Systems particularly deviations CAPA management Change Controls and controlled documentation. Some Experience supporting OEFM electronic forms or similar electronic quality and facilities-management systems preferred. Some und

Strong knowledge and demonstrated experience with Quality Systems particularly deviations CAPA management Change Controls and controlled documentation. Some Experience supporting OEFM electronic forms or similar electronic quality and facilities-management systems preferred. Some und

The position is responsible for supporting Quality and Manufacturing operations through accurate Batch Record Review documentation compliance electronic systems management inventory control and timely operational decision-making. The role requires a strong understanding of GMP require

The position is responsible for supporting Quality and Manufacturing operations through accurate Batch Record Review documentation compliance electronic systems management inventory control and timely operational decision-making. The role requires a strong understanding of GMP require

Manufacturing Operation experience (not quality)Document Management create new documents review and approval of documents. This resource must work with manufacturing operatorsRequirements-Doctorate OR Masters 2 years of Manufacturing Operations experience OR-Bachelors 4 years of Man

Manufacturing Operation experience (not quality)Document Management create new documents review and approval of documents. This resource must work with manufacturing operatorsRequirements-Doctorate OR Masters 2 years of Manufacturing Operations experience OR-Bachelors 4 years of Man

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 team or matrixes environmen

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 team or matrixes environmen

- 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 team or matrixs environmen

- 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 team or matrixs environmen