Cleaning Validation

**Who are we?**: **Amaris Consulting** is an independent technology consulting firm providing guidance and solutions to businesses. With more than 1000 clients across the globe, we have been rolling out solutions in major projects for over a decade - this is made possible by an international team of 7500 people spread across 5 continents and more than 60...

**Responsibilities**: - Working in a biotech/pharmaceutical environment as a consultant / contractor for various clients of PSC - Working closely with client's employees on various projects and various GMP facilities to help client with validation issues - Commuting to PSC clients' manufacturing for validation projects - Protocol development (IQ, OQ, PQ) /...

PES is an international services company providing Project Management, Construction Management, Commissioning & Qualification and Automation services to our clients in the pharmaceutical, nutritional and related sectors. With offices across Europe, Asia and US, our core focus is on consistently delivering high-quality outcomes for our multinational...

Validation Lead GCF Grade Level: 05 Site: Amgen Singapore Manufacturing (ASM) **Role Description** Amgen discovers, develops and delivers innovative human therapeutics. A biotechnology pioneer since 1980, Amgen was one of the first companies to realize the new science’s promise by bringing safe, effective medicines from lab, to manufacturing plant, to...

Roles & Responsibilities **Department**:MSAT **Reports to**:Validation Manager **Purpose** Support equipment qualification and cleaning validation. **Key Responsibilities** - Develop, review and/or approve validation lifecycle document and protocols/reports in accordance with relevant policies, standards, procedures and guidelines, and completed in a...

**Mission Description** Supporting with execution of validation strategy during and leading up to shut down period (november'24 to Jan'25) in AMS **Profile Requirement** - Field experience with validation engineering - Execution of validation, validation test, qualification test - Have performed IQ and OQ and cleaning validation knowledge - Worked with...

**About the job** - Serve as a site Subject Matter Expert for at least 1 specialized validation area - Planning, performance, support and coordination of Computer System Validation, Equipment validation, Sterilization In Place, cleanroom validation, Clean Utilities Validation (IQ/OQ/PQ/CPV) - Maintain validation status of Computer System Validation -...

Preparation and review of qualification documents e.g., User requirement specification, DQ, IQ, OQ and PQ protocol for equipment, utilities & facility in compliance with the regulatory guidelines. - Execution of qualification and validation activities including process, cleaning, computer system, equipment, utilities, and facility. - Preparation and review...

Roles & ResponsibilitiesWe are seeking highly skilled Commissioning, Qualification, and Validation (CQV) Engineers to provide risk-based CQV services for pharmaceutical and biopharmaceutical clients. This role offers opportunities to work across various areas, including process equipment, CIP/SIP (Clean-In-Place/Sterilize-In-Place), and process manufacturing...

Job Description    At WUXI XDC SINGAPORE PRIVATE LIMITED, we are seeking a skilled Validation Associate Engineer to join our team. In this role, you will be responsible for participating in validation activities during the Commissioning & Qualification stage for our Singapore greenfield site and maintaining validation status after release.    Key...

Roles & ResponsibilitiesHiring for fresh grads 2025Responsibilities● Participate in the validation activities during Commissioning & Qualification stage for Singapore greenfield site and be responsible for validation status maintenance after release.● Ensure compliance with appropriate regulatory and company requirements.● Responsible for drafting or...

Job OverviewWe are seeking a highly skilled Validation Expert to join our quality assurance team. As a key member of our team, you will be responsible for ensuring the compliance of our products with regulatory requirements and maintaining high standards of quality and safety in our operations.About the RoleThis is an exciting opportunity to work in a...

**Responsibilities**: - Troubleshoot IT / OT system in pharmaceutical manufacturing floor such as Windows computer connected to equipment - Support qualification of IT / OT system of pharmaceutical manufacturing equipment - Perform user access management - Perform periodic review - Develop and maintain GxP documentation for IT system. **Requirement**: -...

Your Role About the job - Support equipment qualification, system qualification, and cleaning validation. - Develop, review and/or approve validation lifecycle document and protocols/reports in accordance with relevant policies, standards, procedures and guidelines, and completed in a timely fashion. - Manage qualification execution and lead validation...

**Responsibilities**: - Provide Quality oversight to equipment/system qualification, automation qualification (PCS/BAS) and cleaning validation - Review and approve validation lifecycle document and protocols/reports in accordance with relevant policies, standards, procedures and guidelines timely - Review and approve as needed, qualification/validation...

**Responsibilities**: - Provide Quality oversight to equipment/system qualification, automation qualification (PCS/BAS) and cleaning validation - Review and approve validation lifecycle document and protocols/reports in accordance with relevant policies, standards, procedures and guidelines timely - Review and approve as needed, qualification/validation...

**Responsibilities**: - Validation quality review of lifecycle documents and protocols for Automation CSV qualification, EFU qualification, cleaning validation, laboratory equipment qualification, and IT systems qualification. - Review and approve validation lifecycle document and protocols/reports in accordance with relevant policies, standards, procedures...

Validate and qualify parts, processes and products as requested to ensure compliance to QMS. - Implement and follow-up of CAPA and Process Change Control systems. - Create cleaning validation protocols for PQ - Approval and review of all Data Integrity - Serve as Point of Contact for QA Validation - Review and approve all validation/qualification documents...

**Responsibilities**: - Develop, review and/or approve validation lifecycle document and protocols/reports in accordance with relevant policies, standards, procedures and guidelines, and completed in a timely fashion. - Manage qualification execution and lead validation deviation investigation encountered in qualification. - Collaborate with multi functions...

Job description About the job Provide Quality oversight to equipment/system qualification, automation qualification (PCS/BAS) and cleaning validation. Review and approve validation lifecycle document and protocols/reports in accordance with relevant policies, standards, procedures and guidelines in a timely manner. Review and approve as needed,...