Job summary
Working within the Overarching Pharmaceutical Quality Team and directly reporting to the Lifecycle Manager the Validation Engineer is accountable for the validation for Processes, Facilities, Equipment, Cleaning, Computer Software Validations and IT Projects within a pharmaceutical (cGMP) environment.
We are looking for an experienced professional with extensive experience in this field of expertise. Ability to write, review and execute validation protocols is essential.
Key current projects will include working with the site steam sterilisation autoclave to ensure robust validation in accordance with Annex 1 requirements.
Extensive experience working in a pharmaceutical manufacturing role and under a pharmaceutical quality system is essential.
Main duties of the job
The validation engineer is overall responsible for ensuring equipment is suitable for its intended use through the development and execution of qualification documentation to support the System Life Cycle, including facilities, utilities, equipment, and automation.
Responsible for ensuring compliance by following government regulations including but not limited to, HTM, Eudralex Volume 4, FDA (21 CFR 210/211 and Part 11), HC, EMA and PMU and trust policies and procedures.
The Validation Engineer is responsible for interaction with regulatory agencies (MHRA and regional QA), certifying bodies, management, and critical customers.
The role of validation engineer is varied providing multiple opportunities to influence strategy and direction in the realm of validation and sterility assurance. It is also a role dependant on functional expertise where the successful candidate will become a both a voice and arbiter for equipment quality standards across a diverse portfolio of products within the NHS Guy's and St Thomas' hospital production units.
About us
Guys and St Thomas' has a number of licensed and unlicensed manufacturing units based at the site. You will be working in a team of around 100 professionals supporting the licensed activities at the site.
Job description
Job responsibilities
Refer to the attached job description for full details of the role.
Reporting to the Head of Pharmaceutical Lifecycle, you will lead in planning and managing resources so that validation activities and associated documentation are completed in accordance with schedules and meet regulatory requirements.
Provide specialist advice and recommend actions to Pharmacy manufacturing units for the resolution of OOS, deviations and discrepancies.
Review validation practices and processes in manufacturing facilities to ensure the approach taken is in line with industry best practice and meets regulatory requirements.
Project Phase
- Areas of responsibility include the Project Phase of the System Life Cycle approach to qualification as follows:
- The development of User / Functional requirement Specifications (UR/FS), Verification Plans, Commissioning protocols (FAT/SAT, Hardware & Software Tests), Area Qualification protocols (Clean room Grades A-D), Installation / Operation Qualification protocols, Performance Qualification protocols, associated summary reports and Traceability Matrices.
- Preparation of specifications for the purchasing of materials or equipment.
- The execution of commissioning and qualification protocols for GMP Areas, Utilities, manufacturing and packaging equipment.
- Instrumentation qualification including Installation Qualification, Operational Qualification, and Performance Qualification, as applicable.
- Systems qualification including automation and computerized systems (in collaboration with the data integrity / CSV specialist.
- Maintenance of the equipment database in collaboration with the production engineers
Retirement Phase
- Areas of responsibility include the Retirement Phase of the System Life Cycle approach to qualifications as follows:
- Decommissioning of facility, utility, and equipment including computerized systems.
- Migration, archival and destruction requirements for historic data and records.
- Ensuring the equipment calibration status prior to decommissioning.
- Decommissioning impact assessment regarding the decommissioning plan.
- Ensuring the obsoleting of associated documentation such as SOPs, PMs, and calibration procedures
Project Phase
- Areas of responsibility include the execution & data compilation of qualification protocols:
- Inspecting completed installations and observe operations to ensure conformance to design and equipment specifications and compliance with operational, safety, or environmental standards. Reporting any non-conformances in this area and pursuing resolution to make safe where appropriate.
- Ability to clearly document and describe qualification deviations, provide evaluation of impact and to propose resolutions and corrective actions capturing in the pharmaceutical quality system.
- To generate reports including the provision of graphical representation of collected data, and the ability to use data to identify and correct system problems.
- Analyzing validation test data to determine whether systems or processes have met predefined acceptance criteria.
- Operating computer-assisted engineering equipment to perform engineering tasks such as the BMS and EMS.
- Performing detailed calculations to compute and ensure manufacturing, construction, or installation standards or specifications.
- Responsible for liaison with internal and external parties and interaction with various departments in connection with validation studies which may include validation project oversight, auditing, sampling, protocol execution, or data acquisition as required.
- Perform temperature and humidity mapping studies and engineering studies such as design of experiments and range finding studies.
- Creating, populating, and maintaining databases for tracking validation activities, test results, or validated systems until such a time these are fully integrated with the sites electronic QMS.
Documentation Control
- Areas of responsibility include providing documentation required to support document control, change control, and validation activities:
- Responsible for Hazard Analysis/Component Design FMEA (Failure Mode Effective Analysis) / review. Process FMEA/Risk management and provide inputs to the production, QA and other teams directing validation activities.
- Develops supporting documentation such as process flow diagrams, material specifications, and standard operating procedures.
- Participates in the development of Risk Assessments as part of the Verification Plans relevant to equipment, and responsible for updating and maintaining relevant Verification Plans.
- Preparing/review of technical drawings, specifications of electrical systems, and topographical maps to ensure that installation and operations conform to standards and customer requirements.
- Provide documented evidence to support the release of facilities, utilities and equipment for their intended use.
- Create statistically significant sampling plans, when applicable, to support the qualification approach to achieving fitness for use.
- Responsible for performing gap analysis of different manufacturing systems by reviewing Standard Operating Procedures (SOPs) and Work Instructions (WIs) and ensuring the verification of the closure of any identified gaps
Team Work
Areas of responsibility include the ability to work as part of a team in order to meet company objectives:
- Consulting with engineers, production personnel, or others to discuss existing or potential engineering projects or products.
- Coordinating the implementation or scheduling of validation testing with affected
- departments and personnel.
- Assisting project production efforts to assure projects are completed on time.
- Directing or coordinating manufacturing, construction, installation, maintenance, support, documentation, or testing activities to ensure compliance with specifications, codes, or customer requirements.
- Team member for problem solving to resolve production and quality issues including support for OOS / deviation investigation and CAPA generation.
Training
- To design, develop and manage the validation engineering training programme
- To train any other lifecycle team members in the validation process and procedures
- Perform relevant training to operators or other staff on qualification protocols and standard operating procedures.
- To participates in cross-training in Engineering areas of responsibility with the pharmacy and trust engineering teams.
Audit, Research & Development
- To participate in all internal and external audits / inspections
- To act as the site validation SME for all regulatory inspections
- Provides support for process improvement teams and capital projects including support with writing and reviewing equipment bids with the medical equipment team.
- To contribute to the trust R&D agenda by publishing work where possible in peer reviewed journals or relevant pharmaceutical engineering publications.
Job description
Job responsibilities
Refer to the attached job description for full details of the role.
Reporting to the Head of Pharmaceutical Lifecycle, you will lead in planning and managing resources so that validation activities and associated documentation are completed in accordance with schedules and meet regulatory requirements.
Provide specialist advice and recommend actions to Pharmacy manufacturing units for the resolution of OOS, deviations and discrepancies.
Review validation practices and processes in manufacturing facilities to ensure the approach taken is in line with industry best practice and meets regulatory requirements.
Project Phase
- Areas of responsibility include the Project Phase of the System Life Cycle approach to qualification as follows:
- The development of User / Functional requirement Specifications (UR/FS), Verification Plans, Commissioning protocols (FAT/SAT, Hardware & Software Tests), Area Qualification protocols (Clean room Grades A-D), Installation / Operation Qualification protocols, Performance Qualification protocols, associated summary reports and Traceability Matrices.
- Preparation of specifications for the purchasing of materials or equipment.
- The execution of commissioning and qualification protocols for GMP Areas, Utilities, manufacturing and packaging equipment.
- Instrumentation qualification including Installation Qualification, Operational Qualification, and Performance Qualification, as applicable.
- Systems qualification including automation and computerized systems (in collaboration with the data integrity / CSV specialist.
- Maintenance of the equipment database in collaboration with the production engineers
Retirement Phase
- Areas of responsibility include the Retirement Phase of the System Life Cycle approach to qualifications as follows:
- Decommissioning of facility, utility, and equipment including computerized systems.
- Migration, archival and destruction requirements for historic data and records.
- Ensuring the equipment calibration status prior to decommissioning.
- Decommissioning impact assessment regarding the decommissioning plan.
- Ensuring the obsoleting of associated documentation such as SOPs, PMs, and calibration procedures
Project Phase
- Areas of responsibility include the execution & data compilation of qualification protocols:
- Inspecting completed installations and observe operations to ensure conformance to design and equipment specifications and compliance with operational, safety, or environmental standards. Reporting any non-conformances in this area and pursuing resolution to make safe where appropriate.
- Ability to clearly document and describe qualification deviations, provide evaluation of impact and to propose resolutions and corrective actions capturing in the pharmaceutical quality system.
- To generate reports including the provision of graphical representation of collected data, and the ability to use data to identify and correct system problems.
- Analyzing validation test data to determine whether systems or processes have met predefined acceptance criteria.
- Operating computer-assisted engineering equipment to perform engineering tasks such as the BMS and EMS.
- Performing detailed calculations to compute and ensure manufacturing, construction, or installation standards or specifications.
- Responsible for liaison with internal and external parties and interaction with various departments in connection with validation studies which may include validation project oversight, auditing, sampling, protocol execution, or data acquisition as required.
- Perform temperature and humidity mapping studies and engineering studies such as design of experiments and range finding studies.
- Creating, populating, and maintaining databases for tracking validation activities, test results, or validated systems until such a time these are fully integrated with the sites electronic QMS.
Documentation Control
- Areas of responsibility include providing documentation required to support document control, change control, and validation activities:
- Responsible for Hazard Analysis/Component Design FMEA (Failure Mode Effective Analysis) / review. Process FMEA/Risk management and provide inputs to the production, QA and other teams directing validation activities.
- Develops supporting documentation such as process flow diagrams, material specifications, and standard operating procedures.
- Participates in the development of Risk Assessments as part of the Verification Plans relevant to equipment, and responsible for updating and maintaining relevant Verification Plans.
- Preparing/review of technical drawings, specifications of electrical systems, and topographical maps to ensure that installation and operations conform to standards and customer requirements.
- Provide documented evidence to support the release of facilities, utilities and equipment for their intended use.
- Create statistically significant sampling plans, when applicable, to support the qualification approach to achieving fitness for use.
- Responsible for performing gap analysis of different manufacturing systems by reviewing Standard Operating Procedures (SOPs) and Work Instructions (WIs) and ensuring the verification of the closure of any identified gaps
Team Work
Areas of responsibility include the ability to work as part of a team in order to meet company objectives:
- Consulting with engineers, production personnel, or others to discuss existing or potential engineering projects or products.
- Coordinating the implementation or scheduling of validation testing with affected
- departments and personnel.
- Assisting project production efforts to assure projects are completed on time.
- Directing or coordinating manufacturing, construction, installation, maintenance, support, documentation, or testing activities to ensure compliance with specifications, codes, or customer requirements.
- Team member for problem solving to resolve production and quality issues including support for OOS / deviation investigation and CAPA generation.
Training
- To design, develop and manage the validation engineering training programme
- To train any other lifecycle team members in the validation process and procedures
- Perform relevant training to operators or other staff on qualification protocols and standard operating procedures.
- To participates in cross-training in Engineering areas of responsibility with the pharmacy and trust engineering teams.
Audit, Research & Development
- To participate in all internal and external audits / inspections
- To act as the site validation SME for all regulatory inspections
- Provides support for process improvement teams and capital projects including support with writing and reviewing equipment bids with the medical equipment team.
- To contribute to the trust R&D agenda by publishing work where possible in peer reviewed journals or relevant pharmaceutical engineering publications.
Person Specification
Qualifications
Essential
- Batchelor of Science degree in maths, engineering, computer science or related scientific discipline or extensive experience to equivalent level working in a pharmaceutical validation role
Desirable
- Six Sigma / lean processing trained
Experience
Essential
- Familiar with best practices systems such as Total Quality Management, Good Manufacturing Practices, and Lean Manufacturing
- Possesses broad comprehensive knowledge of technologies in pharmaceutical manufacturing and / or packaging industries
- Specific quality and compliance expertise in sterile dose forms and /or functional expertise in validation
- Demonstrated ability to manage, lead and motivate a team.
- Previous experience of using computerised systems for validation data input and trending including reporting and trend analysis
Desirable
- Familiarity with working with Getinge Autoclave or water cascade autoclaves
- Experience with working with WFI generation system
- Hands on experience in pharmaceutical quality assurance and compliance, manufacturing and/or development, working with a broad range of pharmaceutical dosage forms.
- Development of a validation service
Skills
Essential
- Capable of accurately performing mathematical operations and routinely making numerical entries without errors.
- Detail oriented, capable of following instructions precisely, and capable of accurately transcribing detailed information
- Demonstrated understanding of current regulations governing Specials manufacture and the role of the MHRA
- Demonstrated understanding of validation of equipment & processes and experience of ensuring validation plans are adhered to.
Desirable
- Demonstrated ability to manage commissioning and qualification activities for pharmaceutical equipment and systems
- Able to work in a methodical and organized fashion and maintain mental focus to ensure efficient and accurate completion of individual tasks.
Person Specification
Qualifications
Essential
- Batchelor of Science degree in maths, engineering, computer science or related scientific discipline or extensive experience to equivalent level working in a pharmaceutical validation role
Desirable
- Six Sigma / lean processing trained
Experience
Essential
- Familiar with best practices systems such as Total Quality Management, Good Manufacturing Practices, and Lean Manufacturing
- Possesses broad comprehensive knowledge of technologies in pharmaceutical manufacturing and / or packaging industries
- Specific quality and compliance expertise in sterile dose forms and /or functional expertise in validation
- Demonstrated ability to manage, lead and motivate a team.
- Previous experience of using computerised systems for validation data input and trending including reporting and trend analysis
Desirable
- Familiarity with working with Getinge Autoclave or water cascade autoclaves
- Experience with working with WFI generation system
- Hands on experience in pharmaceutical quality assurance and compliance, manufacturing and/or development, working with a broad range of pharmaceutical dosage forms.
- Development of a validation service
Skills
Essential
- Capable of accurately performing mathematical operations and routinely making numerical entries without errors.
- Detail oriented, capable of following instructions precisely, and capable of accurately transcribing detailed information
- Demonstrated understanding of current regulations governing Specials manufacture and the role of the MHRA
- Demonstrated understanding of validation of equipment & processes and experience of ensuring validation plans are adhered to.
Desirable
- Demonstrated ability to manage commissioning and qualification activities for pharmaceutical equipment and systems
- Able to work in a methodical and organized fashion and maintain mental focus to ensure efficient and accurate completion of individual tasks.
Disclosure and Barring Service Check
This post is subject to the Rehabilitation of Offenders Act (Exceptions Order) 1975 and as such it will be necessary for a submission for Disclosure to be made to the Disclosure and Barring Service (formerly known as CRB) to check for any previous criminal convictions.
Applications from job seekers who require current Skilled worker sponsorship to work in the UK are welcome and will be considered alongside all other applications. For further information visit the UK Visas and Immigration website (Opens in a new tab).
From 6 April 2017, skilled worker applicants, applying for entry clearance into the UK, have had to present a criminal record certificate from each country they have resided continuously or cumulatively for 12 months or more in the past 10 years. Adult dependants (over 18 years old) are also subject to this requirement. Guidance can be found here Criminal records checks for overseas applicants (Opens in a new tab).
UK Registration
Applicants must have current UK professional registration. For further information please see
NHS Careers website (opens in a new window).
Additional information
Disclosure and Barring Service Check
This post is subject to the Rehabilitation of Offenders Act (Exceptions Order) 1975 and as such it will be necessary for a submission for Disclosure to be made to the Disclosure and Barring Service (formerly known as CRB) to check for any previous criminal convictions.
Applications from job seekers who require current Skilled worker sponsorship to work in the UK are welcome and will be considered alongside all other applications. For further information visit the UK Visas and Immigration website (Opens in a new tab).
From 6 April 2017, skilled worker applicants, applying for entry clearance into the UK, have had to present a criminal record certificate from each country they have resided continuously or cumulatively for 12 months or more in the past 10 years. Adult dependants (over 18 years old) are also subject to this requirement. Guidance can be found here Criminal records checks for overseas applicants (Opens in a new tab).
UK Registration
Applicants must have current UK professional registration. For further information please see
NHS Careers website (opens in a new window).
