- Responsible for review of qualification and validation documentation, such as protocols, reports and SOPs fornew facilities/cleanroom validations/commissioning activities.
- Responsible for review of qualification protocols (IQ/OQ/PQ) and validation assessments for equipment used in manufacturing suites.
- Review of equipment user requirements.
- Responsible for ensuring validations are executed as per the procedures and protocols.
- Review and approve final validation/qualification packages.
- Execute protocols when required.
- Work with multiple groups (external and internal) in accomplishing the tasks assigned.
- Review vendor documents before and after qualification activities.
- Responsible for ensuring the validation documentation complies with both internal requirements and external regulations.
- Completing risk assessments to ensure equipment, systems, processes and facilities remain in a validated state.
- Conducting impact assessments, root cause analysis and resolution for validation deviations
- Monitoring any changes or maintenance to equipment and make the decisions on whether a full revalidation is required.
- Support in Change plans.
- Support with the environmental monitoring program as required.
- Mapping out the manufacturing processes and finding ways to improve processes.
- Project planning, scheduling and reporting, and working with the Project Manager to ensure delivery timelines are met.
- Excellent problem-solving, time management, and organizational skills, with good attention to detail.
- Self-motivated and conscientious, with a quality first and can-do attitude.
- Excellent communication skills with the ability to create solutions and communicate outcomes effectively with different audiences.
- Demonstrable ability to establish effective collaborative and operational relationships with diverse teams in Bio-Techne.
- Able to work to deadlines in a positive, flexible and pro-active way.
- Ability to engage respectfully with different points of view and to influence others.
- Bachelor's Degree in science or engineering with experience in facilities and equipment validation.
- Experience of GMP manufacturing, facilities, equipment qualifications and process validations, including cleanrooms.
- Knowledge of cGMP manufacturing regulations for the MHRA, FDA and other countries as required.
- Experience in commissioning of new buildings/facilities, including cleanrooms.
- Detailed knowledge of facility and equipment qualification processes.
- Demonstrated track record of high levels of personal and independent productivity.
- Possess excellent verbal and written communication skills.
- Good technical writing skills for drafting and revising validation SOPs that comply with both internal requirements and external regulations.
- Demonstrated collaborative and teamwork skills, with a high level of decision making and problem solving.
- Thorough grasp of H&S, quality, and SOP requirements.
-
Validation Commissiong Engineer
Found in: SonicJobs Direct Apply UK - 1 day ago
GK Search Limited Bristol, United Kingdom Full timeAre you a Validation Commissioning Engineer with a strong cleanroom background? Do you have experience withing a clean room setting as well as taking on commissioning / validation responsbilities? Are you looking to take on a varied, senior and challenging role and be an integral ...
-
Quality Assurance Validation Engineer
Found in: SonicJobs Direct Apply UK - 4 days ago
Li Ca Scientific Recruitment Bristol, United Kingdom Full timeQuality Assurance Validation Engineer · Permanent · Bristol · We are pleased to be partnering with our long standing client in Bristol at an exciting time in their business where they will be commissioning a new Good Manufacturing Practice (GMP) facility. This will be in a new ...
-
Test & Validation Engineer
Found in: Click to Hired UK C2 - 5 days ago
Randstad Technologies Recruitment Bristol, United Kingdom Permanent, Full timeRandstad are recruiting for a Test & Validation Engineer for a client based in Bristol. They are a rapidly growing company that specialise in designing and manufacturing high pressure hydraulic components and systems predominantly for the Automotive and Aerospace sectors. · The ...
-
Testing and Validation Engineer
Found in: Jooble UK O C2 - 5 days ago
Randstad Technologies Recruitment Bristol, United KingdomRandstad are recruiting for a Test & Validation Engineer for a client based in Bristol. They are a rapidly growing company that specialise in designing and manufacturing high pressure hydraulic components and systems predominantly for the Automotive and Aerospace sectors. · The ...
-
Senior Validation Engineer
Found in: Talent UK C2 - 4 days ago
IC Resources Bristol, United Kingdom Full timeAn opportunity has become available for a Senior Validation Engineer to join a revolutionary AI startup based in Bristol. · As a Senior Validation Engineer you will have a number of responsibilities that include;Post silicon validation and characterisation · Create and execute co ...
-
Product Validation Engineer
Found in: Appcast UK C C2 - 5 days ago
Dabster Bristol, United KingdomKey Responsibilities : 1) Develop testbenches for a non-volatile memory IP · 2) Creation of agents · 3) Make adaptations to existing and create new tests for new features of the NVM IP · 4) Show that the relevant tests are passing · 5) Define verification coverage · 6) Testb ...
-
Senior Validation Engineer
Found in: beBee S2 UK - 4 days ago
IC Resources Bristol, United Kingdom Full timeAn opportunity has become available for a Senior Validation Engineer to join a revolutionary AI startup based in Bristol. As a Senior Validation Engineer you will have a number of responsibilities that include;Post silicon validation and characterisationCreate and execute complex ...
-
Product Validation Engineer
Found in: Jooble UK O L C2 - 4 days ago
Dabster Bristol, United KingdomKey Responsibilities:1) Develop testbenches for a non-volatile memory IP2) Creation of agents3) Make adaptations to existing and create new tests for new features of the NVM IP4) Show that the relevant tests are passing5) Define verification coverage6) Testbench Qualification usi ...
-
Senior Validation and Verification Engineer
Found in: Jooble UK O C2 - 3 days ago
European Recruitment Bristol, United KingdomCPU Verification Engineer - Cutting Edge - Global Leader - Reputable Semiconductor Company · Would you like to work at one of the most cutting edge leading semiconductor companies globally? I'm currently on the lookout for multiple Verification Engineers to work within the CPU t ...
-
Senior Validation and Verification Engineer
Found in: Jooble UK O C2 - 5 days ago
European Recruitment Bristol, United KingdomCPU Verification Engineer - Cutting Edge - Global Leader - Reputable Semiconductor Company · Would you like to work at one of the most cutting edge leading semiconductor companies globally? · I'm currently on the lookout for multiple Verification Engineers to work within the CPU ...
-
Senior Verification/Validation Engineer
Found in: Jooble UK O C2 - 1 day ago
AtkinsRéalis Bristol, United KingdomLeading the edge of transformation · You might know us for the great work we do across our wide variety of projects. We're proud to say it's thanks to our people's diversity of thought, expertise and knowledge. So, when it comes to your life outside of work, ask us about our fle ...
-
Senior Validation and Verification Engineer
Found in: Jooble UK O L C2 - 5 days ago
European Recruitment Bristol, United KingdomCPU Verification Engineer - Cutting Edge - Global Leader - Reputable Semiconductor CompanyWould you like to work at one of the most cutting edge leading semiconductor companies globally?I'm currently on the lookout for multiple Verification Engineers to work within the CPU team a ...
-
RF Validation Engineer
Found in: Talent UK C2 - 6 days ago
IC Resources Somerset, United Kingdom Full timeA wireless communications company based in Somerset is seeking an RF Validation Engineer to join their team. · As an RF Validation Engineer you will have a number of responsibilities that include;RF and electronics testing · Automated test development · Analysing test performance ...
-
Engineering Maintenance Assessor
Found in: SonicJobs Direct Apply UK - 1 day ago
Revorec Recruitment Solutions Bristol, United Kingdom Full timeEngineering Maintenance Apprenticeship Assessor · Bristol - Hybrid (Commutable from Gloucester, Weston Super Mare, Bath) · £31,000 - £34,500 DOE + Pension, Funded Training, Mileage Expenses, Progression & Benefits · Are you passionate about engineering and education? Do you have ...
-
Systems Engineer
Found in: SonicJobs Direct Apply UK - 1 day ago
Henderson Scott Bristol, United Kingdom Full timePosition Available: Systems Engineer (Modelling & Tools Team Lead) · Location: Gloucestershire (Hybrid) & Dynamic Working Hours · Salary: Up to £55,000 + Paid Overtime & Company Bonus & Very Good Pension Package · Experience needed: Experience of systems engineering within a comp ...
-
Systems Engineer Team Lead
Found in: SonicJobs Direct Apply UK - 1 day ago
Henderson Scott Bristol, United Kingdom Full timePosition Available: Systems Engineer Team Lead (Modelling & Tools) · Location: Gloucestershire (Hybrid) & Dynamic Working Hours · Salary: Up to £55,000 + Paid Overtime & Company Bonus & Very Good Pension Package · Experience needed: Experience of systems engineering within a comp ...
-
Gas Engineer
Found in: SonicJobs Direct Apply UK - 1 day ago
Niyaa People Ltd Bristol, United Kingdom Full timeWe have an exciting Gas Engineer vacancy available working for a leading maintenance contractor in social housing properties. You will be working mainly in the Bristol area. This is a permanent position, providing a company van, fuel card plus lots more great benefits. · Some gre ...
-
Mechanical Design Engineer
Found in: SonicJobs Direct Apply UK - 5 days ago
Universal Business Team Bristol, United Kingdom Full timeWe are currently seeking a Mechanical Design Engineer to join a well-established, family-run SME based in Bristol. As a Mechanical Design Engineer, you will play a vital role in the design and development of innovative and efficient mechanical systems. Working closely with the en ...
-
Senior Defence Systems Engineer
Found in: SonicJobs Direct Apply UK - 4 hours ago
JAM Recruitment Ltd Bristol, United Kingdom Full timeDo you have extensive experience within systems engineering ? Are you interested in mission system engineering solutions within the Defence sector? If so, the following permanent roles may be right for you... · My client is a market leader within the Defence sector who are lookin ...
-
Principal Systems Engineer
Found in: SonicJobs Direct Apply UK - 3 days ago
JAM Recruitment Ltd Bristol, United Kingdom Full timeDo you want to lead technical teams within systems engineering ? Are you interested in mission system engineering solutions within the Defence sector? If so, the following permanent roles may be right for you... · *Opportunities for Mission Systems Engineers, Senior Systems Engin ...
Quality Validation Engineer - Bristol, United Kingdom - Bio-Techne
Description
Description
By joining the Bio-Techne team you will have an impact on future cutting-edge research. Bio-Techne, and all of its brands, provides tools for researchers in Life Sciences and Clinical Diagnostics.
Bio-Techne is committed to product quality, customer satisfaction, continued improvement, minimising environmental impacts and conserving natural resources. Environmental and quality management is an integral core value and vital part of the Bio-Techne culture.
Position Summary:
The QA Validation Engineer will work with suppliers and employee teams on the commissioning and qualification of a new GMP facility. This includes equipment IQ/OQ/PQ activities as well as validation and qualification of ISO 7 and ISO 8 cleanrooms. They will be responsible for ensuring all systems are running according to required specifications.
Role and Responsibilities
Qualifications
Personal Qualities and Attributes:
Education and Experience:
Bio-Techne is committed to product quality, customer satisfaction, continued improvement, minimising environmental impacts and conserving natural resources. Environmental and quality management is an integral core value and vital part of the Bio-Techne culture.