Process Validation

Job Description Job Description Salary: About Aura: At Aura, our mission is to develop a new class of oncology targeted therapies that deliver meaningful therapeutic benefit to a range of cancer indications with high unmet need in which we believe we can establish a new standard of care. We are driven by our passion and commitment to science and the patients...

Process Validation Engineer (Contract)RESPONSIBILITIESOverseeing and reviewing design and construction work related to process improvements in a cGMP manufacturing facility.Supporting startup, Commissioning, Qualification, and Validation (CQV) of process equipment, and developing process technical transfer documents.Collaborating with senior leadership to...

Process Validation Engineer (Contract)RESPONSIBILITIESOverseeing and reviewing design and construction work related to process improvements in a cGMP manufacturing facility.Supporting startup, Commissioning, Qualification, and Validation (CQV) of process equipment, and developing process technical transfer documents.Collaborating with senior leadership to...

Responsibilities: Understand and able to review vendor Qualification document package in line with regulatory requirements. Knowledge of System and Functional Risk assessment / management, defining risk mitigation plan. Should have good Stakeholder management skills to interact with customer, business, and vendors efficiently. Subject matter...

For Equipment Validation services in the Manufacturing area.WHAT MAKES YOU A FIT:The Technical Part:Bachelor's Degree in Life Science or Engineering and five (5) years of experience in Validation Life Cycle within the Medical Device Industry.Bilingual (English and Spanish)Administrative and according to business needsExperience in: Process...

For Equipment Validation services in the Manufacturing area.WHAT MAKES YOU A FIT:The Technical Part:Bachelor's Degree in Engineering and five years of experience in Validation Life Cycle within the Medical Device Industry.Bilingual (English and Spanish)Administrative and according to business needsExperience in: Equipment troubleshooting.Validation Life...

Responsibilities: Validation Strategy: Develop validation strategies aligned with regulatory standards. Protocol Generation: Author and review validation protocols for processes and equipment. Execution: Lead validation studies and analyze data, ensuring adherence to timelines. Reporting: Prepare comprehensive validation reports with findings and...

Responsibilities: Validation Strategy: Develop validation strategies aligned with regulatory standards. Protocol Generation: Author and review validation protocols for processes and equipment. Execution: Lead validation studies and analyze data, ensuring adherence to timelines. Reporting: Prepare comprehensive validation reports with findings and...

For Equipment Validation services in the Manufacturing area.WHAT MAKES YOU A FIT:The Technical Part:Bachelor's Degree inEngineering and five years of experience in Validation Life Cycle within theMedical Device Industry.Bilingual (English and Spanish)Administrativeand according to business needsExperience in: Troubleshooting of equipment.ValidationLife...

We Believe Quality is Paramount. If You Do Too, We Need You! An award-winning, venture capital-backed biotech is looking for a Senior Validation Engineer to be at the forefront of quality engineering and validation efforts as we grow. This role is tasked with developing validation plans, handling protocols and reports, maintenance of DMR, CAPA/Deviation...

Validation Test Lead @@@ Boston, MA Relevant Experience (in Yrs) Overall IT Experience: 10 years + Validation Lead Experience: 5 years + Test Lead Experience with hands on testing deliverables: 5 years + Hyperion Validation/Testing experience: 2 years+ Nuvolo Validation/Testing experience/Infra Qualification: 2 years+ Life Sciences Projects: 4 years+...

Responsiilities: Must have 12+ years of experience in GxP validation testing on pharmaceutical domain. 3 + years of experience in managing testing projects in multiple towers. Experience in test effort estimation & resources planning across all the projects. Responsible for demand/capacity planning, resource management, stakeholder management ...

Welcome to the forefront of innovation in cutting edge patient treatments! We are thrilled to present an incredible opportunity to join our high performing organization. As a leader within the life science industry, we are constantly pushing the boundaries of what is possible and redefining the standards of excellence. Our dynamic team is composed of vibrant...

When you join the growing BILH team, you're not just taking a job, you're making a difference in people's lives.Job Type:RegularScheduled Hours:40Work Shift:Day (United States of America)Job Summary: Under general supervision of the Director of Coding and Validation, the Coding Validator II is responsible for performing quality reviews on medical records to...

Our client is a leading maker of Power Management ICs and Modules for mobile devices including smartphones, tablets, wearables, and IoT devices. The company has a unique technology that helps solve power consumption in mobile devices while improving RF efficiency, as well as using a digital signal processing technique to restore linearity. They are currently...

Role: Validation/Test Lead Experience : 8+ years' Work Loca tion: Boston, MA Job Type : Contract Duties & Responsibilities Validation/Test hands on in manufacturing/lab systems in pharma companies Overall IT Experience: 10 years + Validation Lead/Test Experience: 5 years + Tools sets experience: •Micro Focus ALM (Client ALM)•MS Office tools...

Job Description As a Model Validation / Quality Assurance Analyst, you will partner with a group of software developers and product owners who implement probabilistic algorithms for modeling insurance application from catastrophic events, while consulting with them to identify areas for validation, with an emphasis on developing creative approaches to...

Job DescriptionJob DescriptionThis position is a 3 month contract.Provides technical support in the development and implementation of customer applications and company products. Conducts on-site enhancements, maintenance and support for new and existing systems. Implements new product configurations/software upgrades, installs network devices and/or hardware...

Job DescriptionJob DescriptionThis position is a 3 month contract.Provides technical support in the development and implementation of customer applications and company products. Conducts on-site enhancements, maintenance and support for new and existing systems. Implements new product configurations/software upgrades, installs network devices and/or hardware...

Welcome to the forefront of innovation in cutting edge patient treatments! We are thrilled to present an incredible opportunity to join our high performing organization. As a leader within the life science industry, we are constantly pushing the boundaries of what is possible and redefining the standards of excellence. Our dynamic team is composed of vibrant...