758 Validation Specialist jobs in the United Kingdom

Hobson Prior is seeking an Engineering Validation Specialist on a permanent basis, to join a dynamic team in London.

In this role, you will ensure that all equipment and computerized systems used in regulated processes meet the required standards. You will act as a subject matter expert on validation, ensuring compliance with EU, UK, and FDA regulations while supporting quality management activities.

Please note that to be considered for this role you must have the right to work in this location.

Responsibilities:

• Ensure all equipment, facilities, and systems are validated and compliant with regulatory requirements.
• Review and approve validation documents, protocols, and reports.
• Collaborate with various departments to align validation plans with business objectives.
• Support audits and inspections by acting as a subject matter expert.
• Address and resolve issues related to validation and compliance.
• Maintain inspection readiness and ensure documentation meets quality standards.
• Manage changes and deviations effectively, ensuring timely resolution.

Key Skills and Requirements:

• Experience working within a cGMP pharmaceutical/biotechnology manufacturing environment
• Knowledge of computerized system validation
• Experience working on equipment validation

For more information, please contact William Hay

If you are interested in applying to this exciting opportunity, then please click 'Apply' or to speak to one of our specialists visit the 'Contact Us' page.

Hobson Prior is a leading life sciences recruiter focused on finding exceptional people and matching them with the finest positions across the globe. Hobson Prior is acting as an Employment Agency in relation to this vacancy.

By submitting this application, you confirm that you've read and understood our privacy policy, which informs you how we process and safeguard your data -

ROLE OVERVIEW

We are supporting a leading Pharmaceutical company who are seeking a Senior Validation Specialist to join their team in the Essex area. As the Senior Validation Specialist, you will play a crucial role in ensuring that all GMP processes, equipment, and computerised systems meet regulatory and business requirements.

KEY DUTIES AND RESPONSIBILITIES:

Your duties as the Senior Validation Specialist will be varied however the key duties and responsibilities are as follows:

1. Provide ongoing engineering validation support for GxP processes, equipment and computerised systems across the site.

2. Act as a subject matter expert in EU and FDA regulations, ensuring compliance with validation policies and procedures.

3. Review and approve validation documentation, ensuring timely and compliant submissions.

4. Support QMS activities, including deviation investigations and change control impact assessments.

ROLE REQUIREMENTS:

To be successful in your application to this exciting role as the Senior Validation Specialist we are looking to identify the following on your profile and past history:

1. Relevant degree in Engineering, Sciences, or equivalent.

2. Extensive industry experience in engineering validation, with a focus on computer system validation.

3. A working knowledge and practical experience with GxP regulations and guidelines.

Key Words: Senior Validation Specialist / GxP / Computer System Validation / Engineering Validation / Life Sciences / Regulatory Compliance / QMS / EU Regulations / FDA Regulations / Validation Documentation / Deviation Investigations

Hyper Recruitment Solutions Ltd (HRS) is an Equal Opportunities employer. We welcome applications from anyone who meets the role requirements. HRS exclusively supports the Life Science sectors, combining recruitment expertise with scientific knowledge to help you advance your career.

Customer Validation Specialist

Hybrid working

£28,000 - £31,000 DOE

London Bridge

This role will focus on carrying out detailed validation checks, supporting our fraud prevention efforts, and ensuring accuracy in line with market best practice.

You will work closely with both the Customer Care and Underwriting teams, with particular focus on complex validations that require a high level of accuracy and judgement.

What you'll do:

• Conduct validation checks on a wide range of documents and policies, ensuring data accuracy against internal systems
• Using tools to identify document fraud and flag cases when relevant
• Handle inbound enquiries and conduct outbound calls with customers as part of the validation process, providing clear explanations and ensuring a positive customer experience
• Record and track validation outcomes with precision and in compliance with procedures
• Escalate potential fraud cases in line with agreed processes
• Collaborate with Customer Care and Underwriting to ensure compliance and service consistency
• Spot trends and highlight opportunities for automation or process improvements
• Maintain close understanding of our customers and products by occasionally supporting Customer Fulfilment activities (phone, email, live chat)
• Support colleagues by resolving validation related queries to provide comprehensive responses to customers

What we're looking for:

• Previous experience in a customer service or validation operations role within a regulated environment
• Strong attention to detail with an ability to spot discrepancies quickly and accurately
• Good working knowledge of document handling and validation processes
• Confidence using digital tools and platforms to manage workload effectively
• Clear written and verbal communication skills
• Ability to work independently while collaborating with the wider team
• Experience in a fraud or compliance setting desirable

Please be aware this advert will remain open until the vacancy has been filled. Interviews will take place throughout this period, therefore we encourage you to apply early to avoid disappointment.

Tate is acting as an Employment Business in relation to this vacancy.

Tate is committed to promoting equal opportunities. To ensure that every candidate has the best experience with us, we encourage you to let us know if there are any adjustments we can make during the application or interview process. Your comfort and accessibility are our priority, and we are here to support you every step of the way. Additionally, we value and respect your individuality, and we invite you to share your preferred pronouns in your application.

Want a 3D Career? Join Norgine.

At Norgine, our colleagues Dare themselves to be different and try new things, Drive to achieve their goals and beyond, and Develop themselves and their community.

We call it the 3D career at Norgine and it offers you a fully-rounded experience with no limits.

Bring everything about yourself that you’re proud of, whether that’s your passion for making a difference, focus on others’ well-being, or intellectual curiosity to unleash in a fast-paced environment and supportive community.

In return, get a sense of belonging, a long-term career with ongoing development and upskilling, and a company that cares about people’s wellness as much as you do.

Because at Norgine, we transform lives with innovative healthcare solutions.

We have an exciting opportunity for a Validation Specialist - 12 months FTC to join Norgine.

Core Responsibilities

Enhance Validation practice and compliance; support improvement to validation system; streamline processes. Identify risk areas and required mitigation to meet regulatory inspections e.g. MHRA, FDA, Notified Body etc. through routine compliance activities and specific validation projects

Requirements

•  Maintain all validation compliance activities in a timely manner in line with the Site Validation Plan.

• Work closely with all site departments reliant on validation support to facilitate validation aspects of all projects.

• Advise and contribute to Process Flow and Risk Assessment activities.

• Draft Validation Plans, Protocols and Reports when required.

• Subject matter expert within Investigations, CAPA, Quality Events.

• Functional expert for Change Request Impact assessments when delegated or in absence of Validation Section Leader

• Report validation status to Validation Section Leader

• Be aware of updated regulatory guidance and modify site procedures accordingly to maintain compliance

• Contribute to the Validation Community of practice when required.

Acting in a capacity on behalf of Norgine Ltd. to:

Ensure that the Site Validation Master Plan is maintained accurately and Validation Plans are implemented for all relevant aspects of Equipment, Process, Cleaning, Computer Systems, Facilities/Utilities and Analytical Method validation. Maintain and support the updating of Validation Schedules within a team based validation structure.

Author or review and approve the development and implementation of Validation Master Plans, protocols, reports and standard operating procedures relevant to Validation.

Technical input into all Validation Lifecycle activities as part of a cross functional team. Provide guidance and support to other internal site departments ensuring compliance with applicable regulatory requirements (MHRA, EU, FDA, U.S., Notified Body and international), International Standards, and quality/validation regulations and guidance documents.

Schedule and coordinate the review of process and equipment validation and re-validation / periodic review in accordance with the established Company validation policy and associated procedures. Complete validation protocols and reports, and ensure compliance with all relevant Quality Standards and regulatory requirements.

Provide support to Norgine global organisation, (e.g. participating in the Validation Community of Practice) as appropriate, relating to validation activities and associated regulatory activities and procedures.

Serve as subject matter expert and/or team member to support Quality Investigations, CAPA, customer complaint reports, audit findings, failure investigations and continuous improvement opportunities. Ensure accurate and timely resolution and closure to all issues.

Contribute to and perform related training on site with regards to validation lifecycle and compliance.

Prepare and present validation reports and Key Performance Indicators for management review. Review and monitor trends; initiate continuous improvement opportunities, communicate any matters outside the norm to the Validation Section Leader / Site Director of Quality.

Support the IT department to ensure compliance with software and hardware validation regulatory requirements. Provide support in achieving / maintaining compliance with 21 CFR Part 11 / EU GMP Annex 11 and other guidance documents as appropriate to business needs.

Comply with all statutory and Company requirements for health and safety.

The above list is not exhaustive and the job holder may be expected to perform other reasonable tasks within the boundaries of their skills, in the interest of the job and the Company’s performance.

RELATIONSHIPS:

• Maintains excellent working relationships with all departments across Hengoed site.

• Liaise with other manufacturing sites within Norgine and through the External Network Structure.

SKILLS & KNOWLEDGE

• Bachelors/Undergraduate Degree in a science or engineering related discipline (chemistry, biology, process engineering, pharmaceutical or medical technology preferred). Alternatively, in house or external training in Validation, Quality and Regulatory activities.

• Previous Validation experience (minimum 5 - 10 years) in Healthcare/Pharmaceutical manufacturing/packing, medical device or biologics industry.

• Previous team leadership experience (direct or indirect) desirable, operating in a matrix organization.

• Demonstrated expertise in cGMP’s, EU/FDA regulations, GAMP guidelines, assessment of risk and drafting of plans, protocols, reports and procedures

• Demonstrated understanding of Quality Assurance, Quality Control and Validation Risk Based Principles

• Demonstrated computer skills and a working knowledge of basic computer software (Microsoft Office, Excel, Visio etc. preferred)

• Demonstrated verbal and written communication skills, including the ability to conduct oral presentations

• Demonstrated success working within a team environment

• Ability to travel by car and/or plane, typically up to 5%. Additional travel may be required based on business need.

KEY COMMITTEE MEMBERSHIPS :

Validation Community of Practice.

Benefits

Our benefits may vary per location. Please liaise with the Norgine TA representative to obtain more information.

Sound good? Find out more about the career you’ll have with Norgine, then apply here.

#LI-PP1

Important: Visa sponsorship is not available for this role. Applicants must already have the right to work in the UK. Prior experience with Continued Process Verification (CPV) / Process Validation is essential.

Title: Technical Associate II, MSAT (CPV / Process Validation SME)

Location: Stevenage, UK (occasional London)

Working Pattern: On-site 5 days per week. Fixed shifts also available if preffered

About the Company

A leading biotechnology company at the forefront of advanced cell and gene therapy. With a state-of-the-art site in Stevenage, they are delivering commercial manufacturing in the UK and already have products approved in the US. Their approach combines computational design with modular T-cell programming to develop adaptable therapies for cancer and autoimmune disease.

The Opportunity

This is an expansion role within MSAT, focused on process validation and CPV. You’ll act as the subject matter expert for validation activities, supporting GMP manufacturing and technology transfer. It’s a hands-on, fully on-site role offering exposure to ATMP manufacturing and commercial readiness in a fast-growing biotech.

Key Responsibilities

• Act as SME for process validation and CPV, supporting routine GMP manufacturing.
• Provide floor and on-call support during tech transfer and batch execution.
• Conduct product impact assessments, root cause analysis, and CAPAs.
• Review and maintain GMP documentation including batch records, sampling plans, and material specifications.
• Contribute to CPV data entry, trending, and verification.
• Support technology transfer of new products into GMP.
• Represent MSAT in cross-functional teams and support process improvements.

Requirements

Essential:

• 2–5 years’ experience in GMP manufacturing.
• Direct experience with process validation or CPV.
• Strong technical writing, communication, and problem-solving skills.
• Ability to work independently and cross-functionally in a fast-paced environment.
• Fully on-site availability in Stevenage.

Preferred:

• Experience in ATMP, biologics, or other regulated manufacturing.
• Background in technology transfer or process/product lifecycle management.
• Degree in science, engineering, or equivalent practical experience.
• Familiarity with QMS, deviations, CAPAs, and regulatory requirements.
• Exposure to aseptic processing, cell culture, or downstream processing.
• Experience with data analysis tools and continuous improvement methodologies.

Important: Visa sponsorship is not available for this role. Applicants must already have the right to work in the UK. Prior experience with Continued Process Verification (CPV) / Process Validation is essential.

Title: Technical Associate II, MSAT (CPV / Process Validation SME)

Location: Stevenage, UK (occasional London)

Working Pattern: On-site 5 days per week. Fixed shifts also available if preffered

About the Company

A leading biotechnology company at the forefront of advanced cell and gene therapy. With a state-of-the-art site in Stevenage, they are delivering commercial manufacturing in the UK and already have products approved in the US. Their approach combines computational design with modular T-cell programming to develop adaptable therapies for cancer and autoimmune disease.

The Opportunity

This is an expansion role within MSAT, focused on process validation and CPV. You’ll act as the subject matter expert for validation activities, supporting GMP manufacturing and technology transfer. It’s a hands-on, fully on-site role offering exposure to ATMP manufacturing and commercial readiness in a fast-growing biotech.

Key Responsibilities

• Act as SME for process validation and CPV, supporting routine GMP manufacturing.
• Provide floor and on-call support during tech transfer and batch execution.
• Conduct product impact assessments, root cause analysis, and CAPAs.
• Review and maintain GMP documentation including batch records, sampling plans, and material specifications.
• Contribute to CPV data entry, trending, and verification.
• Support technology transfer of new products into GMP.
• Represent MSAT in cross-functional teams and support process improvements.

Requirements

Essential:

• 2–5 years’ experience in GMP manufacturing.
• Direct experience with process validation or CPV.
• Strong technical writing, communication, and problem-solving skills.
• Ability to work independently and cross-functionally in a fast-paced environment.
• Fully on-site availability in Stevenage.

Preferred:

• Experience in ATMP, biologics, or other regulated manufacturing.
• Background in technology transfer or process/product lifecycle management.
• Degree in science, engineering, or equivalent practical experience.
• Familiarity with QMS, deviations, CAPAs, and regulatory requirements.
• Exposure to aseptic processing, cell culture, or downstream processing.
• Experience with data analysis tools and continuous improvement methodologies.

Want a 3D Career? Join Norgine.

At Norgine, our colleagues Dare themselves to be different and try new things, Drive to achieve their goals and beyond, and Develop themselves and their community.

We call it the 3D career at Norgine and it offers you a fully-rounded experience with no limits.

Bring everything about yourself that you’re proud of, whether that’s your passion for making a difference, focus on others’ well-being, or intellectual curiosity to unleash in a fast-paced environment and supportive community.

In return, get a sense of belonging, a long-term career with ongoing development and upskilling, and a company that cares about people’s wellness as much as you do.

Because at Norgine, we transform lives with innovative healthcare solutions.

We have an exciting opportunity for a Validation Specialist - 12 months FTC to join Norgine.

Core Responsibilities

Enhance Validation practice and compliance; support improvement to validation system; streamline processes. Identify risk areas and required mitigation to meet regulatory inspections e.g. MHRA, FDA, Notified Body etc. through routine compliance activities and specific validation projects

Requirements

•  Maintain all validation compliance activities in a timely manner in line with the Site Validation Plan.

• Work closely with all site departments reliant on validation support to facilitate validation aspects of all projects.

• Advise and contribute to Process Flow and Risk Assessment activities.

• Draft Validation Plans, Protocols and Reports when required.

• Subject matter expert within Investigations, CAPA, Quality Events.

• Functional expert for Change Request Impact assessments when delegated or in absence of Validation Section Leader

• Report validation status to Validation Section Leader

• Be aware of updated regulatory guidance and modify site procedures accordingly to maintain compliance

• Contribute to the Validation Community of practice when required.

Acting in a capacity on behalf of Norgine Ltd. to:

Ensure that the Site Validation Master Plan is maintained accurately and Validation Plans are implemented for all relevant aspects of Equipment, Process, Cleaning, Computer Systems, Facilities/Utilities and Analytical Method validation. Maintain and support the updating of Validation Schedules within a team based validation structure.

Author or review and approve the development and implementation of Validation Master Plans, protocols, reports and standard operating procedures relevant to Validation.

Technical input into all Validation Lifecycle activities as part of a cross functional team. Provide guidance and support to other internal site departments ensuring compliance with applicable regulatory requirements (MHRA, EU, FDA, U.S., Notified Body and international), International Standards, and quality/validation regulations and guidance documents.

Schedule and coordinate the review of process and equipment validation and re-validation / periodic review in accordance with the established Company validation policy and associated procedures. Complete validation protocols and reports, and ensure compliance with all relevant Quality Standards and regulatory requirements.

Provide support to Norgine global organisation, (e.g. participating in the Validation Community of Practice) as appropriate, relating to validation activities and associated regulatory activities and procedures.

Serve as subject matter expert and/or team member to support Quality Investigations, CAPA, customer complaint reports, audit findings, failure investigations and continuous improvement opportunities. Ensure accurate and timely resolution and closure to all issues.

Contribute to and perform related training on site with regards to validation lifecycle and compliance.

Prepare and present validation reports and Key Performance Indicators for management review. Review and monitor trends; initiate continuous improvement opportunities, communicate any matters outside the norm to the Validation Section Leader / Site Director of Quality.

Support the IT department to ensure compliance with software and hardware validation regulatory requirements. Provide support in achieving / maintaining compliance with 21 CFR Part 11 / EU GMP Annex 11 and other guidance documents as appropriate to business needs.

Comply with all statutory and Company requirements for health and safety.

The above list is not exhaustive and the job holder may be expected to perform other reasonable tasks within the boundaries of their skills, in the interest of the job and the Company’s performance.

RELATIONSHIPS:

• Maintains excellent working relationships with all departments across Hengoed site.

• Liaise with other manufacturing sites within Norgine and through the External Network Structure.

SKILLS & KNOWLEDGE

• Bachelors/Undergraduate Degree in a science or engineering related discipline (chemistry, biology, process engineering, pharmaceutical or medical technology preferred). Alternatively, in house or external training in Validation, Quality and Regulatory activities.

• Previous Validation experience (minimum 5 - 10 years) in Healthcare/Pharmaceutical manufacturing/packing, medical device or biologics industry.

• Previous team leadership experience (direct or indirect) desirable, operating in a matrix organization.

• Demonstrated expertise in cGMP’s, EU/FDA regulations, GAMP guidelines, assessment of risk and drafting of plans, protocols, reports and procedures

• Demonstrated understanding of Quality Assurance, Quality Control and Validation Risk Based Principles

• Demonstrated computer skills and a working knowledge of basic computer software (Microsoft Office, Excel, Visio etc. preferred)

• Demonstrated verbal and written communication skills, including the ability to conduct oral presentations

• Demonstrated success working within a team environment

• Ability to travel by car and/or plane, typically up to 5%. Additional travel may be required based on business need.

KEY COMMITTEE MEMBERSHIPS :

Validation Community of Practice.

Benefits

Our benefits may vary per location. Please liaise with the Norgine TA representative to obtain more information.

Sound good? Find out more about the career you’ll have with Norgine, then apply here.

#LI-PP1