Validation Engineer
Hybrid
England, United Kingdom
£ 65 / hour
Freelance
30-01-2025
Job Specifications
We are seeking a skilled Validation Engineer with expertise in single-use technology (SUT) to support validation activities related to bioreactors, mixing systems, and other disposable process equipment used in biopharmaceutical manufacturing. The successful candidate will be responsible for the development and execution of validation protocols (IQ/OQ/PQ), ensuring compliance with GMP, FDA, EMA, and industry standards. This role is critical in ensuring the reliability, efficiency, and regulatory compliance of bioprocessing equipment.
Key responsibilities:
Develop, execute, and document validation protocols (IQ, OQ, PQ) for single-use bioreactors, mixing systems, and other process equipment.
Ensure compliance with GMP, FDA, EMA, ISO, and industry standards related to single-use technology.
Perform risk assessments and gap analyses for single-use components to ensure process integrity.
Collaborate with cross-functional teams, including Manufacturing, Quality Assurance, Process Development, and Regulatory Affairs, to support validation efforts.
Investigate and resolve validation deviations, anomalies, and non-conformances.
Author and review Standard Operating Procedures (SOPs), User Requirement Specifications (URS), and Validation Master Plans (VMPs).
Lead and participate in FAT, SAT, and commissioning of single-use systems.
Conduct performance qualification studies, including sterility, extractables & leachables testing, and integrity testing.
Stay updated with industry trends, technological advancements, and regulatory changes affecting single-use technologies.
Provide training and technical support on validation processes to internal stakeholders.
Qualifications:
Bachelor’s or Master’s degree in Engineering, Biotechnology, Biochemistry, or a related field.
5+ years of validation experience in the biopharmaceutical or medical device industry.
Hands-on experience with single-use bioreactors, mixing systems, and filtration assemblies.
Strong knowledge of GMP, FDA 21 CFR Part 11, ISO 13485, USP, and ICH guidelines.
Experience with risk-based validation approaches and industry best practices.
Familiarity with data integrity principles, electronic validation systems, and automation is a plus.
Please get in touch if you are interested in applying!
About the Company
Placing Talent that Makes A Difference. Talent attraction and retention are critical to our client’s success; Hamlyn Williams’ mission is to support and enable this through the delivery of high-quality staffing solutions. Founded in 2011, we are a global organisation with local offices across North America and Europe, and over 160 colleagues. We cover the Financial Services, Cyber Security, Professional Services, Technology, Life Sciences and Manufacturing industries. Our people are ambitious, we persevere for our custo... Know more
Related Jobs
- Company Name
- Ntrinsic Consulting
- Job Title
- Lead Software Engineer
- Job Description
- Software engineering lead: Hybrid, Swindon once per week, 1 year contract Job Description: "Client & Project: We are seeking for a new talent to join the company where you will have the opportunity to collaborate in the project 'Credit Risk Service'. The client is a financial services company. Responsibilities: As an Application Lead, you will be responsible for leading the effort to design, build, and configure applications, acting as the primary point of contact. Expected to be an SME, collaborate and manage the team to perform. Responsible for team decisions. Engage with multiple teams and contribute on key decisions. Expected to provide solutions to problems that apply across multiple teams. Expert proficiency in .NET Core is required. Expert level of proficiency in Amazon S3 is recommended. MongoDB Expert proficiency is suggested. Develop innovative solutions to enhance application performance Lead and mentor team members to achieve project goals Collaborate with stakeholders to gather requirements and ensure project alignment Conduct regular code reviews to maintain high-quality standards Stay updated on industry trends and technologies to drive continuous improvement Must have - api development using .net core framework 6/8, mongo db or any other no sql DB, experience in writing unit test cases using j-unit, n-unit, x-unit etc.., good design skills, understanding of microservices architecture Good to have - AWS cloud, Lambda's" #contract #work #engineeringlead #Hybrid
- Company Name
- Ubique Systems
- Job Title
- Software Engineer
- Job Description
- Skill: Kafka Confluence Kafka infra person (provisioning, patching, upgrade, incident mgt etc.). Bank uses Confluent platform version 7 (equivalent to Kafka 3.7) additional skills would be AWS, Kubernetes, puppet. The Bank has 2 clusters, one on prep and one on AWS
- Company Name
- McGregor Boyall
- Job Title
- Senior ServiceNow Developer
- Job Description
- Senior ServiceNow Developer - ITAM, HAM, SAM, ITSM Glasgow (2/3 days onsite) - 12 month contract PAYE up to £570/day Global financial services client is seeking a Senior ServiceNow Developer to join the team. Responsible for the overall architecture, design, implementation, and integrity of the ServiceNow application within the enterprise. Key Responsibilities: Hands-on technical delivery of the ServiceNow technical solutions. Research systems and/or programs to determine causes of failure or poor operational performance; then define, test, and implement detailed solutions. Stay current on product developments/ releases to a level required for demonstrations and thought leadership. Skills and Experience required: Hands on experience in technical solution design and implementation of the ServiceNow application. Ability to produce documentation at various levels including technical and consumer facing. Strong background in ITAM process and ServiceNow HAM and SAM Pro development. Expertise and experience with ServiceNow or an equivalent ITSM toolset are essential. ServiceNow experience in the areas of ITSM, ITBM, ITOM, CSM or SecOps and HR products are desirable. ServiceNow Certifications in all areas are highly desirable. Experience in multiple application architectures and supporting technologies. Expertise with scripting languages such as JavaScript. Web service proficiency (REST, SOAP) as well as XML and JSON knowledge. If this is of interest and you have the required skills, please submit your CV over for immediate consideration. McGregor Boyall is an equal opportunity employer and do not discriminate on any grounds.
- Company Name
- GIOS Technology Limited
- Job Title
- AWS Solution Architect
- Job Description
- We are hiring for AWS Solution Architect Location: London / 1 day Per week in Office Expertise in containerization and orchestration tools like Kubernetes (K8S), EKS, and AKS. Familiarity with event-driven architectures and automation using AWS Lambda, CloudWatch, and EventBridge. Utilize cloud observability tools such as CloudWatch, EventBridge, and X-Ray. Automate architectures using AWS EventBridge, Systems Manager, and Lambda. Apply enterprise integration patterns and practices (REST, event-driven architectures). Implement CI/CD practices and tools (AWS CodePipeline, GitLab, GitHub). Strong understanding of enterprise integration patterns such as REST APIs and microservices. Experience with cloud cost optimization strategies and tools. Key Skills: Kubernetes / AWS / Cloud observability / CI/CD practices / REST APIs