Cleaning Validation Specialist Job at Amaris Consulting (Singapore)

Validation Specialist

Location

United States , Shawnee

Salary:

Not provided

Argenta

Expiration Date

Until further notice

Requirements

Bachelor’s degree in Engineering, Life Sciences, Pharmaceutical Sciences, or a closely related field, and 2 years of experience in pharmaceutical validation, quality systems, or related GMP-regulated environments. Must have hands-on experience conducting equipment qualification (IQ/OQ/PQ) for manufacturing and laboratory equipment. Must have experience with thermal validation using Ellab or equivalent systems, including thermocouple mapping and lethality validation. Must have experience leading or supporting sterilization validation (e.g., SIP, depyrogenation, or aseptic process simulations) aligned with ISO 17665 and PDA guidelines. Must have experience with computerized system validation (CSV) in accordance with 21 CFR Part 11, GAMP 5, and Data Integrity (ALCOA+) principles. Must have experience in process validation (PV) and continued process verification (CPV), including protocol drafting, sampling plans, execution, and statistical analysis. Must have experience in cleaning validation, including MACO and PDE-based limit calculations, toxicological risk assessments, and swab sampling strategies. Must have experience with statistical tools, including JMP, for data analysis, trend monitoring, and process capability assessments. Must have experience working with cloud-based system migrations and enterprise platforms (including SAP, Empower, MODA, and Fiix). Must have experience with Quality Management Systems (QMS), including document control, audit trail review, and deviation/CAPA processes. Must have experience with FDA 21 CFR Parts 210, 211, 820, EU Annex 1, and relevant ICH and PDA regulatory standards. Must have good written and verbal communication skills in English.

Job Responsibility

Develop User Requirement Specifications (URS), Functional Requirements (FRS), Configuration/Design Specifications, Risk Assessments, Requirement Traceability Matrices (RTMs), Validation Plans (VMP), Test Plans, and Validation Summary Reports (VSR). Execute validation lifecycle documents including Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ) for both manufacturing and laboratory systems. Lead and support Process Validation (PV) activities: define sampling plans, verify Critical Process Parameters (CPPs), collect in-process and final product samples, and compile validation reports per ICH Q8–Q10. Support and execute Aseptic Process Simulations (Media Fills), including operator qualification, process simulation design, and result evaluation in compliance with sterility assurance standards. Perform Cleaning Validation, including swab sampling strategy, MACO/PDE-based residue limit calculations, and execution of cleaning protocols. Conduct validation of thermal processes such as Steam-in-Place (SIP) and Depyrogenation tunnels, including thermocouple mapping, endotoxin challenge studies, and F0 calculation using tools such as Ellab. Facilitate risk assessments for GxP computerized systems, ensuring compliance with 21 CFR Part 11, GAMP 5, and Data Integrity (ALCOA+) guidelines. Execute retrospective validation for legacy systems and close compliance gaps via change control, system remediation, and updated documentation. Support cloud-based system transitions and data migrations for systems such as SAP ByDesign, MODA, Empower, ZenQMS, and Fiix, ensuring business continuity and data integrity. Perform Continued Process Verification (CPV), using statistical tools such as JMP for trend analysis, control charting, and capability studies (Cp/Cpk). Serve as a validation representative during internal and regulatory audits
address audit findings through CAPAs and technical document revisions. Draft and review Standard Operating Procedures (SOPs), Risk Assessments, and final validation documentation for various qualification and compliance activities.

Fulltime

Validation Specialist

The role of the Validation Specialist is to implement and execute tasks relating...

Location

Ireland , Stamullen

Salary:

Not provided

PCI Pharma Services

Expiration Date

October 31, 2026

Requirements

Bachelor’s or associate degree or Diploma / Certificate in Quality / Validation
minimum 2 years’ experience working in Manufacturing or Quality
Demonstrate interest in Validation
Capability to follow clear goals, communicate clearly and ensure progress to completion meeting predefined targets
Ability to manage multiple tasks and set priorities
Problem Solving and Troubleshooting skills
Self-motivated with a results driven approach
Flexibility to work across different shifts on request in line with business needs
Adaptable and ability to work collaboratively
Proficient in Microsoft Office products (incl. Excel, PowerPoint, Word, etc.)

Job Responsibility

Ensure safe work practices are being followed at all times, report any near misses immediately to the EHS Department
Ensuring all validation activities on site relating to Facility, Equipment and Processes meet the expectations of clients but more specifically meet regulatory requirements (HPRA/ FDA)
Comply with Site Validation Master Plan
Generate validation protocols for new and existing computer systems, facilities, equipment and processes and review/approve all reports
Generate and maintain documentation for cleaning validation performed at PCI sites in Ireland
Execute validation activities, with minimal supervision, in conjunction with Technical, Production and Engineering functions
Perform sampling in support of validation studies, including AQL, and cleaning validation
Manage tooling validations and associated documentation
Ensure the strict implementation of validation procedures plus the timely and accurate completion of all validation documentation
Support complaint investigations, deviation investigations and change controls as required

Fulltime

Senior Validation Specialist

The role of the Senior Validation Specialist is to implement and execute tasks r...

Location

Ireland , Stamullen, Co. Meath

Salary:

Not provided

PCI Pharma Services

Expiration Date

Until further notice

Requirements

Min 3 years' Quality experience
Min 2 years' Validation experience
Equipment Qualification (IQ, OQ, PQ) – Hands on experience in protocol generations, execution, completion
Process Validation (PV) experience
New Product Introduction (NPI) - Generation, execution and close out of validation projects
Communication Customer/Internal stake holders/Suppliers
Experience with deviation, CAPA processes
Flexible and able to manage multiple priorities simultaneously
Periodic reviews

Job Responsibility

Support the validation effort for all Strategic Projects on site
Ensure all validation activities on site relating to Facility, Equipment and Processes meet the expectations of clients but more specifically meet regulatory requirements (HPRA/ FDA)
Prepare, review and or approval of qualification and/or validation documentation (VMPs, specifications, protocols, reports etc.) in relation to instrument, equipment, facilities (including cold stores), utilities, automated systems, manufacturing processes and cleaning processes including FAT, SAT, IQ, OQ, PQ phases in conjunction with program Quality representation
Drive solutions, in conjunction with the appropriate department, to ensure customer related validation problems are communicated and corrective actions are in place and closed in a timely manner
Thorough investigation of Quality and Validation issues using Root Cause Analysis methodology and implementation of robust corrective and preventative actions to prevent recurrence
Support change controls as required
Execute validation activities, with minimal supervision, in conjunction with Technical, Production and Engineering functions
Ensure the strict implementation of validation procedures plus the timely and accurate completion of all validation documentation
Supports the coordination & scheduling of packaging validation activities in alignment with planning & packaging functions
Perform Periodic reviews, revalidations, and continued process verifications on a scheduled basis

Fulltime

Accounts Receivable Specialist

We are looking for an Accounts Receivable Specialist to support day-to-day accou...

Location

United States , Oakland

Salary:

Not provided

Robert Half

Expiration Date

Until further notice

Requirements

2–5+ years of experience handling receivables, cash applications, or general accounting work
Hands-on experience with ERP/accounting systems (e.g., Sage Intacct or similar)
Understanding of nonprofit accounting standards (GAAP) or work supporting grant-funded programs
Strong accuracy and ability to manage large volumes of transactions across multiple entities
Skilled in investigating, reconciling, and resolving payment discrepancies
Clear and professional communication skills, both written and verbal

Job Responsibility

Track daily deposits by downloading bank reports, logging cash/check receipts, and entering details into internal systems
Assign payments to the correct projects and funding sources and notify stakeholders of deposits
Keep accurate, well-organized records of all receipts and transactions
Investigate unknown payments using internal tools and external platforms (e.g., PayPal Giving Fund, CyberGrants, Zeffy, Neon One)
Contact donors, partners, or teams to clarify missing details and resolve allocation issues
Monitor and clear unidentified receipts promptly
Reconcile cash activity weekly against bank records and monthly across platforms, bank data, and accounting systems
Review and resolve variances, escalating issues when needed
Prepare clean, validated data and backup for system uploads
Maintain tracking files for fundraising and payment platforms (e.g., Stripe, Square, Eventbrite, Benevity)

What we offer

medical insurance
vision insurance
dental insurance
life insurance
disability insurance
401(k) plan

Fulltime

Specialist Software Engineer

Location

India , Hyderabad

Salary:

Not provided

Amgen

Expiration Date

Until further notice

Requirements

Doctorate degree / Master's degree / Bachelor's degree and 8 to 13 years of experience in Computer Science, IT or related field
Solid understanding and experience in cloud computing principles, particularly within the AWS ecosystem
Knowledge of HTML, CSS, JavaScript, and Typescript along with popular front-end frameworks like React or Angular
Proficiency in Python/PySpark development, Fast API, REST APIs, Databricks, DevOps Tools, CI/CD, Data Ingestion, and GraphQL
In-depth knowledge of data engineering concepts, ETL processes, and data architecture principles
Experienced with API integration, serverless, microservices and Event-driven architecture
Ability to write clean, efficient, and maintainable code
Experience with software engineering best practices, version control (Git, Subversion, etc.), CI/CD (Jenkins, Maven, etc.), automated unit testing, and DevOps
Ability to quickly learn, adapt, and apply new technologies
Strong problem-solving and analytical skills

Job Responsibility

Design, prototype, develop, and deploy cloud-based full-stack applications using modern software engineering practices and Generative AI technologies
Build responsive, accessible, and high-performing user interfaces using React and TypeScript
Develop reusable UI components, design patterns, APIs, modules, integrations, reports, and enhancements
Partner with UX designers, product managers, business stakeholders, QA, and engineering teams
Analyze functional and technical requirements and convert them into scalable software architecture
Lead technical design discussions and architecture reviews
Build and integrate back-end services, APIs, and system interfaces
Ensure software quality through clean code, code reviews, automated testing, CI/CD, performance optimization, accessibility validation, and defect resolution
Create and maintain technical documentation for architecture, design, deployment, disaster recovery, operations, and support
Provide ongoing support, troubleshooting, maintenance, and performance improvements for production applications

Fulltime

Site Agent

We are seeking an experienced, contract Site Agent to lead the successful execut...

Location

United Kingdom , Reigate

Salary:

375.00 - 425.00 GBP / Day

Randstad

Expiration Date

July 04, 2026

Requirements

SMSTS (Site Management Safety Training Scheme)
Temporary Works Coordinator (TWC) qualification (essential)
CSCS Card applicable to a management role (Black Manager Card preferred)
Degree / HND / HNC in Civil Engineering or Construction Management
Full, valid UK Driving License (essential)
Valid EUSR Water Hygiene Card (highly desirable)
Tier 1 Pedigree: Direct, previous experience working in a contract management capacity (Sub Agent / Site Agent) within a Tier 1 civil engineering environment is essential
Clear Career Progression: A demonstrable history of technical progression moving from Engineer to Sub Agent, and into a Site Agent role
AMP Framework & Sector Experience: Prior experience delivering clean water, wastewater, or heavy drainage infrastructure assets under the AMP (Asset Management Period) Framework is highly desirable
IT & Systems Literacy: Fully proficient with modern digital site management tools, electronic compliance platforms, and programming software

Job Responsibility

Package Delivery & Autonomy: Manage and deliver large-scale civil infrastructure packages from inception to handover, supporting and reporting directly to the Project Manager
Multidisciplinary Interfacing: Coordinate civil works with parallel engineering disciplines and specialist trades. Manage physical and logistical crossovers, ensuring structures are delivered in sequence for seamless system integration without interface delays
Planning & Programming: Plan on-site works, produce and update detailed 4-week lookahead programs, and actively feed progress data into the master Primavera P6 delivery program
Commercial Administration: Maintain strong commercial awareness
proactively identify project delays, track variations, and draft/raise Early Warning Notices (EWNs) under the contract
Technical Compliance: Review project drawings and specifications, raise Requests for Information (RFIs) and Technical Queries (TQs), and compose/review robust Safe Systems of Work (SSOW), including RAMS, ITPs, and permits
Temporary Works Coordinator (TWC): Act as the technical authority on-site for temporary works, utilizing your deep knowledge of requirements to coordinate closely with site teams and fulfill TWC duties
HSEQ Enforcement: Enforce absolute compliance with all HSEQ requirements specific to major civils delivery, including live services, lifting operations (LOLER/PUWER), excavations, and environmental constraints
Culture & Stakeholder Management: Maintain a professional, collaborative work culture with all subcontractors, clients, asset owners, and delivery stakeholders

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AI Specialist

Fugro is a global leader in geodata solutions, operating at the forefront of dig...

Location

Netherlands , Nootdorp

Salary:

Not provided

Fugro

Expiration Date

Until further notice

Requirements

BSc degree in Computer Science, Data Science or a related field
A minimum of 3 years in AI model development and deployment
Certifications in AWS or Azure AI Fundamentals
Python for Data Science
Proficiency in Python and ML libraries
Understanding of data preparation and feature engineering
Basic knowledge of MLOps and Cloud platforms
Excellent English language skills, both written and oral

Job Responsibility

Build and train AI models using approved frameworks and datasets
Optimize models for performance and scalability
Validate outputs and ensure alignment with business requirements
Prepare and clean data for modelling activities
Integrate AI models into applications and workflows
Maintain data lineage and documentation
Ensure adherence to responsible AI principles and organisational policies
Work with the NextGen AI Lead to prioritise tasks and deliverables
Participate in knowledge sharing and continuous improvement activities
Collaborate with data engineers, IT teams, innovation groups and business stakeholders

What we offer

Competitive salary
29 holidays per year based on a fulltime employment (of which 4 are appointed by Fugro management) and the possibility to purchase 12 additional days
Extensive career & training opportunities both nationally and internationally
Flexible working hours and the ability to work from home in accordance with your manager and corporate policies
Commuting allowance
Modern pension scheme
Collective health insurance
Possibility to register with our corporate fitness plan
Coaching options through our EAP (Employee Assistance Program)

Fulltime

Field Tech Senior Manager

Location

Philippines , Taguig City

Salary:

Not provided

NTT DATA

Expiration Date

Until further notice

Requirements

Strong verbal and written communication skills
Manages escalated client situations with a focus on building positive client relationships
Excellent understanding of internal service processes and able to articulate these to clients
Strong technical and product knowledge

Job Responsibility

Supervise and manage a team of IT desktop support associates, smart hands, network & voice resources
Ensure the team provides effective & timely day-to-day IT support, advice, guidance & diagnosis, and timely incident resolution for client
Facilitate the day-to-day management of client incidents and requests & tech room operations ensuring a timely response within the established Service Level Agreement (SLA)
Perform follow up on incidents/requests with client as needed to ensure customer satisfaction
Assist the client portfolio to meet their goals in infra management and uptime
Manage the day-to-day work activities of the team, including rosters, timelines, expected customer experience, billing, prioritizing, and allocating workflow
Provide timely and effective advice, information, and expert technical interpretation on complex IT support matters
Work closely with HRBP to ensure corrective actions are put in place as needed
Place the customer at the center of all decision making
Be the key IT Support point of contact for the client portfolio

Fulltime

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Cleaning Validation Specialist

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Job Responsibility

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