Validation scientist job description
Updated March 14, 2024
8 min read
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Example validation scientist requirements on a job description
Validation scientist requirements can be divided into technical requirements and required soft skills. The lists below show the most common requirements included in validation scientist job postings.
Sample validation scientist requirements
- Bachelor's degree in a relevant field.
- Knowledge of quality assurance principles.
- Experience in validation processes.
- Proficiency in relevant software.
- Excellent problem solving skills.
Sample required validation scientist soft skills
- Strong communication skills.
- Ability to work independently.
- Organizational and time management skills.
- Ability to handle stressful situations.
Validation scientist job description example 1
Canfield Scientific validation scientist job description
We are looking for an experienced Imaging Method Validation Scientist develop high quality validation documentation, design method validation approach, interpret data, and analyze results across multiple teams. The right candidate will have exceptional communication skills, both written and verbal, meets deadlines while managing changing priorities, is highly motivated with a proactive skillset to work autonomously, and excels in a fast-paced work environment.
Job Description:
Collaborates with cross-functional teams to develop high-quality documentation such as validation reports/plans, white papers outlining imaging methods, manuscripts, publications, or similar
Develop method validation procedures and approaches to assess and validate imaging and image analysis methods for accuracy, reproducibility, and repeatability
Writes statistical methods sections of manuscripts and abstracts for publications or presentations
Define and establish acceptance criteria for image analysis methods
Reviews, interprets, and analyzes data for technical, quality, and compliance to method validation plans
Monitors, processes, and codes data for statistical analysis utilizing various technologies
Interprets and presents data descriptions and analysis results, including the explanation of statistical techniques used, the assumptions made, and the generalization of results
Core Requirements:
Bachelor's degree related field such as biotechnology, engineering, statistics, etc. preferred and at least 3-5 years of relevant work experience
Ability to design a method validation approach based on goal of the project
Demonstrated ability utilizing Microsoft Office Suite
Ability to understand business process changes and accommodating for them when providing solutions, use statistical programming models, and experienced in navigating and manipulating data within a database
Desired:
Photography knowledge/background is advantageous
Canfield Scientific, Inc. is a core imaging lab providing custom photographic systems, image monitoring, and centralized analysis services for the pharmaceutical, biotechnology and cosmetics industries supporting global clinical trials providing primary endpoint data and supporting documentation. Canfield has supported over 3,200 clinical studies, works worldwide with thousands of clinical study sites, and has been retained by many of the world's leading biotechnology and pharmaceutical companies. Canfield's imaging equipment leads the industry providing high-quality, registered, reproducible clinical images. This, together with proactive clinical image monitoring and a world class quality assurance regimen, sets the gold standard in image quality for clinical studies.
Job Description:
Collaborates with cross-functional teams to develop high-quality documentation such as validation reports/plans, white papers outlining imaging methods, manuscripts, publications, or similar
Develop method validation procedures and approaches to assess and validate imaging and image analysis methods for accuracy, reproducibility, and repeatability
Writes statistical methods sections of manuscripts and abstracts for publications or presentations
Define and establish acceptance criteria for image analysis methods
Reviews, interprets, and analyzes data for technical, quality, and compliance to method validation plans
Monitors, processes, and codes data for statistical analysis utilizing various technologies
Interprets and presents data descriptions and analysis results, including the explanation of statistical techniques used, the assumptions made, and the generalization of results
Core Requirements:
Bachelor's degree related field such as biotechnology, engineering, statistics, etc. preferred and at least 3-5 years of relevant work experience
Ability to design a method validation approach based on goal of the project
Demonstrated ability utilizing Microsoft Office Suite
Ability to understand business process changes and accommodating for them when providing solutions, use statistical programming models, and experienced in navigating and manipulating data within a database
Desired:
Photography knowledge/background is advantageous
Canfield Scientific, Inc. is a core imaging lab providing custom photographic systems, image monitoring, and centralized analysis services for the pharmaceutical, biotechnology and cosmetics industries supporting global clinical trials providing primary endpoint data and supporting documentation. Canfield has supported over 3,200 clinical studies, works worldwide with thousands of clinical study sites, and has been retained by many of the world's leading biotechnology and pharmaceutical companies. Canfield's imaging equipment leads the industry providing high-quality, registered, reproducible clinical images. This, together with proactive clinical image monitoring and a world class quality assurance regimen, sets the gold standard in image quality for clinical studies.
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Validation scientist job description example 2
Ortho Clinical Diagnostics validation scientist job description
The Career Potential
Ortho Clinical Diagnostics is committed to improving and saving lives with diagnostics. To do this we hire people who share this dream and are ready for new adventures. As a valued team member, you will carve your own career path and be part of building this company stronger and better than ever before. There is no limit to the experiences, opportunities and new directions you will have access to here at Ortho Clinical Diagnostics. More importantly, you will be driving the surge of a whole new direction in important medicine. That's something we can all take pride in as we take this journey together.
Ortho is known in the industry as a leader in customer service and support. Deeply understanding and exceeding the needs of our clinical lab, hospital and blood bank customers is what we do. It's who we are. If you join Ortho, no matter what your role, you will be expected to keep that Customer Excellence focus in your work.
The Opportunity
As the company continues to grow we are seeking a Validation Scientist II, III (Multiple Openings). The Validation Scientist organizes and leads moderately complex validation projects primarily focused on the validation of new supplies of MicroSlide raw materials, such as those that are replacing materials that have been obsoleted by a supplier (e.g. chemicals and biologicals). This position will work both independently and as a team member to conduct root-cause investigations of factory production failures as needed. Defines and develops test designs to evaluate the failure on product performance and to assess residual product risk. Analyzes data and documents findings in technical reports including a recommendation for the fitness of use of the product.
This position is in Rochester, NY.
The Responsibilities
Leadership of multiple projects concurrently.Plans, leads and documents feasibility trials for new raw materials and/or manufacturing materials.Creates and/or updates existing risk assessments (e.g. FMEA and Product Hazard Analysis).Writes validation plans and reports.Implementation of validated materials into production.Effectively communicates results to management and cross-functional teams; summarizes and presents project status updates to senior leadership team as needed.
The Individual
Minimum BS degree in scientific field (Chemistry, Biology, Biotechnology, or Chemical Engineering field preferred); MS or PhD preferred.Required Travel:>5%
Requirements for Level II:
3-5 years of experience working in regulated environment (FDA, ISO, UDSA, etc.) Experience with VITROS MicroSlide technology required.Experience with Ortho Change Control system required.Experience with data analysis in VAX, LIMS, Excel and Minitab (or equivalent) required.Demonstrated validation experience required; 2+ years preferred.Strong organizational skills, ability to multi-task, and prioritize multiple projects.
Requirements for Level III:
5-7 years of experience working in regulated environment (FDA, ISO, UDSA, etc.) Experience with VITROS MicroSlide technology required.Experience with Ortho Change Control system required.Experience with data analysis in VAX, LIMS, Excel and Minitab (or equivalent) required.Demonstrated validation experience required; 2+ years preferred.Strong organizational skills, ability to multi-task, and prioritize multiple projects.
EOE/AA Disability/Veteran
#LI-SP1
Ortho Clinical Diagnostics is committed to improving and saving lives with diagnostics. To do this we hire people who share this dream and are ready for new adventures. As a valued team member, you will carve your own career path and be part of building this company stronger and better than ever before. There is no limit to the experiences, opportunities and new directions you will have access to here at Ortho Clinical Diagnostics. More importantly, you will be driving the surge of a whole new direction in important medicine. That's something we can all take pride in as we take this journey together.
Ortho is known in the industry as a leader in customer service and support. Deeply understanding and exceeding the needs of our clinical lab, hospital and blood bank customers is what we do. It's who we are. If you join Ortho, no matter what your role, you will be expected to keep that Customer Excellence focus in your work.
The Opportunity
As the company continues to grow we are seeking a Validation Scientist II, III (Multiple Openings). The Validation Scientist organizes and leads moderately complex validation projects primarily focused on the validation of new supplies of MicroSlide raw materials, such as those that are replacing materials that have been obsoleted by a supplier (e.g. chemicals and biologicals). This position will work both independently and as a team member to conduct root-cause investigations of factory production failures as needed. Defines and develops test designs to evaluate the failure on product performance and to assess residual product risk. Analyzes data and documents findings in technical reports including a recommendation for the fitness of use of the product.
This position is in Rochester, NY.
The Responsibilities
Leadership of multiple projects concurrently.Plans, leads and documents feasibility trials for new raw materials and/or manufacturing materials.Creates and/or updates existing risk assessments (e.g. FMEA and Product Hazard Analysis).Writes validation plans and reports.Implementation of validated materials into production.Effectively communicates results to management and cross-functional teams; summarizes and presents project status updates to senior leadership team as needed.
The Individual
Minimum BS degree in scientific field (Chemistry, Biology, Biotechnology, or Chemical Engineering field preferred); MS or PhD preferred.Required Travel:>5%
Requirements for Level II:
3-5 years of experience working in regulated environment (FDA, ISO, UDSA, etc.) Experience with VITROS MicroSlide technology required.Experience with Ortho Change Control system required.Experience with data analysis in VAX, LIMS, Excel and Minitab (or equivalent) required.Demonstrated validation experience required; 2+ years preferred.Strong organizational skills, ability to multi-task, and prioritize multiple projects.
Requirements for Level III:
5-7 years of experience working in regulated environment (FDA, ISO, UDSA, etc.) Experience with VITROS MicroSlide technology required.Experience with Ortho Change Control system required.Experience with data analysis in VAX, LIMS, Excel and Minitab (or equivalent) required.Demonstrated validation experience required; 2+ years preferred.Strong organizational skills, ability to multi-task, and prioritize multiple projects.
EOE/AA Disability/Veteran
#LI-SP1
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Validation scientist job description example 3
Eurofins validation scientist job description
Eurofins Scientific is an international life sciences company, providing a unique range of analytical testing services to clients across multiple industries, to make life and our environment safer, healthier and more sustainable. From the food you eat, to the water you drink, to the medicines you rely on, Eurofins works with the biggest companies in the world to ensure the products they supply are safe, their ingredients are authentic and labelling is accurate.
Eurofins is the global leader in food, environment, pharmaceutical and cosmetic product testing and in agroscience Contract Research Organisation services. Eurofins is one of the market leaders in certain testing and laboratory services for genomics, discovery pharmacology, forensics, advanced material sciences and in the support of clinical studies, as well as having an emerging global presence in Contract Development and Manufacturing Organisations. The Group also has a rapidly developing presence in highly specialised and molecular clinical diagnostic testing and in-vitro diagnostic products.
In over just 30 years, Eurofins has grown from one laboratory in Nantes, France to 55,000 staff across a decentralised and entrepreneurial network of 900 laboratories in over 50 countries. Eurofins offers a portfolio of over 200,000 analytical methods to evaluate the safety, identity, composition, authenticity, origin, traceability and purity of biological substances and products.
In 2020, Eurofins generated total revenues of EUR € 5.4 billion, and has been among the best performing stocks in Europe over the past 20 years.
* Applies GMP/GLP in all areas of responsibility, as appropriate
* Demonstrates and promotes the company vision
* Attendance - Regular attendance and punctuality
* Administration - Administer metrology program; maintain equipment database; tag instruments; perform scheduling with internal clients and external vendors
* Maintenance, Calibration, Qualification, Repair, and Troubleshooting - Routine laboratory equipment such as balances, EMS sensors, thermometers, fume hoods, refrigerators, sonicators, chart recorders, ovens, and pH meters
* Investigations - Initiate and perform equipment failure investigations under minimal supervision
* Vendor Calibrations - Send instruments/equipment to vendors for calibration and repair; coordinate services on-site; communicate with vendors and service personnel regarding instrumentation issues; write transmittal letters regarding shipments and service required; review vendor equipment certificates for compliance and accuracy
* Time Tracking - Maintain departmental spreadsheets to provide time trending and task data
* Continued Growth - Learn operation, maintenance, calibration, repair, and troubleshooting of instruments/equipment through reading equipment manuals, working with experienced metrologists, attendance at internal and external courses, and vendor contact
* Procedures - Review and provide technical input on calibration and qualification procedures
* EMS - Ability to navigate system, review trends, and retrieve/compile data
* Conducts all activities in a safe and efficient manner
* Performs other duties as assigned
* The ideal candidate would possess :
* Relevant experience in a laboratory setting
* Basic competency with laboratory instrumentation
* Strong computer, scientific, and organizational skills
* Excellent communication (oral and written) and attention to detail
* Ability to work independently and as part of a team, self-motivation, adaptability, and a positive attitude
* Ability to learn new techniques, perform multiple tasks simultaneously, keep accurate records, follow instructions, and comply with company policies
* Bachelor's degree in physical science (chemistry, physics, etc.); course work in instrumental analysis helpful; instrument repair and troubleshooting helpful
* Basic Minimum Qualifications :
* At least one year laboratory instrumentation experience; experience working with tools, diagnostic equipment, and electronic hardware; PC experience required
* Authorization to work in the United States indefinitely without restriction or sponsorship
Position is full-time, Monday - Friday 8:00am - 5:00pm. Candidates currently living within a commutable distance of Portage, MI are encouraged to apply.
* Excellent full time benefits including comprehensive medical coverage, dental, and vision options
* Life and disability insurance
* 401(k) with company match
* Paid vacation and holidays
Eurofins is a M/F, Disabled, and Veteran Equal Employment Opportunity and Affirmative Action employer.
Eurofins is the global leader in food, environment, pharmaceutical and cosmetic product testing and in agroscience Contract Research Organisation services. Eurofins is one of the market leaders in certain testing and laboratory services for genomics, discovery pharmacology, forensics, advanced material sciences and in the support of clinical studies, as well as having an emerging global presence in Contract Development and Manufacturing Organisations. The Group also has a rapidly developing presence in highly specialised and molecular clinical diagnostic testing and in-vitro diagnostic products.
In over just 30 years, Eurofins has grown from one laboratory in Nantes, France to 55,000 staff across a decentralised and entrepreneurial network of 900 laboratories in over 50 countries. Eurofins offers a portfolio of over 200,000 analytical methods to evaluate the safety, identity, composition, authenticity, origin, traceability and purity of biological substances and products.
In 2020, Eurofins generated total revenues of EUR € 5.4 billion, and has been among the best performing stocks in Europe over the past 20 years.
* Applies GMP/GLP in all areas of responsibility, as appropriate
* Demonstrates and promotes the company vision
* Attendance - Regular attendance and punctuality
* Administration - Administer metrology program; maintain equipment database; tag instruments; perform scheduling with internal clients and external vendors
* Maintenance, Calibration, Qualification, Repair, and Troubleshooting - Routine laboratory equipment such as balances, EMS sensors, thermometers, fume hoods, refrigerators, sonicators, chart recorders, ovens, and pH meters
* Investigations - Initiate and perform equipment failure investigations under minimal supervision
* Vendor Calibrations - Send instruments/equipment to vendors for calibration and repair; coordinate services on-site; communicate with vendors and service personnel regarding instrumentation issues; write transmittal letters regarding shipments and service required; review vendor equipment certificates for compliance and accuracy
* Time Tracking - Maintain departmental spreadsheets to provide time trending and task data
* Continued Growth - Learn operation, maintenance, calibration, repair, and troubleshooting of instruments/equipment through reading equipment manuals, working with experienced metrologists, attendance at internal and external courses, and vendor contact
* Procedures - Review and provide technical input on calibration and qualification procedures
* EMS - Ability to navigate system, review trends, and retrieve/compile data
* Conducts all activities in a safe and efficient manner
* Performs other duties as assigned
* The ideal candidate would possess :
* Relevant experience in a laboratory setting
* Basic competency with laboratory instrumentation
* Strong computer, scientific, and organizational skills
* Excellent communication (oral and written) and attention to detail
* Ability to work independently and as part of a team, self-motivation, adaptability, and a positive attitude
* Ability to learn new techniques, perform multiple tasks simultaneously, keep accurate records, follow instructions, and comply with company policies
* Bachelor's degree in physical science (chemistry, physics, etc.); course work in instrumental analysis helpful; instrument repair and troubleshooting helpful
* Basic Minimum Qualifications :
* At least one year laboratory instrumentation experience; experience working with tools, diagnostic equipment, and electronic hardware; PC experience required
* Authorization to work in the United States indefinitely without restriction or sponsorship
Position is full-time, Monday - Friday 8:00am - 5:00pm. Candidates currently living within a commutable distance of Portage, MI are encouraged to apply.
* Excellent full time benefits including comprehensive medical coverage, dental, and vision options
* Life and disability insurance
* 401(k) with company match
* Paid vacation and holidays
Eurofins is a M/F, Disabled, and Veteran Equal Employment Opportunity and Affirmative Action employer.
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Updated March 14, 2024
Updated March 14, 2024