Validation Expert Jobs
By Novartis At , Indianapolis $92,800 - $139,200 a year
Proven project management experience in a cross-functional environment (e.g. multi-site, technical development, other functions).
Strong working knowledge of quality systems and regulatory requirements across multiple health authorities.
3+ years experience in manufacturing/ manufacturing science and/or technology/technical development/quality.
Previous aseptic manufacturing experience is required.
Experience in executing process validation.
Provide technical expertise and facilitate establishment of Quality Risk Assessment (as needed).
Ingénieur Intégration Validation (H/F)
By Equans North America At Atlanta, GA, United States
Linux : administration, création de script
Réseau: TCP/UDP, IP, Ethernet, FTP, WIFI
Bases de données : Oracle, MySql
Protocoles de communication : services web, RS232, RS485, J1708, J1939, etc.
Contrat V.I.E Durée 24 mois
pour une meilleure qualité de ville
Packaging Validation Specialist Jobs
By BeneFit Cosmetics At , San Francisco, 94104 $29.80 - $45.00 an hour
Create and maintain Benefit’s packaging material restriction list; alert packaging engineers if a package under development does not meet restrictions
1- 3 years of Experience in Packaging Development
Knowledge of cosmetic packaging materials & development
Knowledge of package safety tests
Maintain packaging material database and perform country specific import quantity calculations as needed for global reporting.
Complete country specific packaging material reporting to authorities as required to ensure company compliance to applicable packaging regulatory/environmental legislations globally.
Quality Assurance Specialist Ii, Validation
By Novavax, Inc. At , Gaithersburg, Md
Interface with system owners, IT, and facilities engineering to ensure all user and compliance requirements are tested.
Evaluate vendor qualification packages and create Novavax wrappers.
0-5 years of experience in Pharma or/and Biotech environment
At least 2 years of experience with any of the following: Facility, Laboratory or Manufacturing Equipment, Cleaning, and/or Process Validation
Excellent verbal and written communication skills.
Experience working on cross-functional teams.
Quality Assurance Area Specialist - Validation
By Novo Nordisk At , Durham, Nc
General knowledge of Batch Review Processes (BRP), validation processes and Quality Management Systems (QMS) preferred
With P&O review/agreement, equivalent combination of education and internal NN business/operational experience may be substituted for degree as appropriate
Keeps track & informs management about fluctuation in workload
Family Focused Benefits including 12 weeks paid parental & 6 weeks paid family medical leave
Follow all safety & environmental requirements in the performance of duties
Minimum of one (1) year of QA and/or cGMP related experience required, preferably in the pharmaceutical or medical device industry
Model Validation Specialist Jobs
By Shell At Houston, TX, United States
Minimum of (5 – 8) five to eight years working experience in risk management in the Energy industry
Inventory of Models used within the Risk Management Function (RMF) and without as requested
Candidate must have general knowledge of energy markets, natural gas, power, oil crude & products, LNG and Freight
Excellent critical thinking and problem-solving skills
Strong analytical skills with attention to detailed data analysis and complex model configuration
Ability to multi-task and accommodate organic changes in requirements for deliverables
Healthcare Validation Specialist Jobs
By Trinity IT Services At United States
· Knowledge in working with current issue and effect management software
· Knowledge of risk/hazard analysis of business requirements leveraging GAMP 5
· Develops manual test cases with associated test runs using requirement and functional specification documents
· Knowledge of performing validation of BECS Software and Standard Operating Procedures
· Knowledge of FDA and international medical device regulations
· Prefer knowledge and understanding of applicable Regulated Software Application (RSA) modules
Validation Specialist Jobs
By Eurofins Lancaster Laboratories At Easton, MD, United States
Demonstrates strong client service skills, teamwork, and collaboration.
Strong computer, scientific, and organizational skills
A combination of college and related technical experience will be considered (e.g., 14+ years’ experience)
Three years of regulatory experience including quality system/program development
Validation Specialist responsibilities include, but are not limited to, the following
Benefits & Perks To Foster Work/Life Balance
Validation Specialist - Actalent
By Actalent At Parsippany, NJ, United States
Strong understanding and experience with Aseptic techniques, cell manufacture processes and technologies preferred
Review of Validation protocol related data evidence
Review of CSV related data evidence
Review of QC related data evidence
Review of Tech Transfer related data evidence
Ed Trauma Data Validation Specialist - Emergency Room
By Aspirus At , Wausau, 54401, Wi
Full benefits packages available for part- and full-time status.
Annual competencies as required by Aspirus and/or various regulatory agencies based on entity and/or job position.
PTO accrual from day one!
Generous retirement plan with match available for all positions.
Wellness program for employees and their families.
Compassion. Accountability. Collaboration. Foresight. Joy.
Labor And Delivery Nurse Validation Specialist
By GE Healthcare At , Arlington Heights, 60004, Il
Collaborate with Product Management and UX teams on Formative and Summative test initiatives.
Recommend and implement improvements. Interpret requirements for testability and ensure coverage in test case design.
4 years of clinical L&D experience
4 years of experience in NICHD fetal strip interpretation
2 years of experience as a Charge nurse
Working knowledge of word and excel (or equivalent tools)
Validation Specialist 2 Jobs
By Salas O'Brien At , Remote $100,000 - $115,000 a year
Compile, analyze qualification/validation data, and develop Trace Matrices (TM).
Manage multiple projects, ensuring effective customer communication.
Demonstrate excellent written, verbal, and presentation skills.
Assess project scope, manage change, and solve problems.
Bachelor’s degree in a scientific, technical, or engineering discipline with 5 to 7 years of experience working within an FDA-regulated environment.
Considerable knowledge of FDA regulations / cGMPs, and Good Automated Manufacturing Practices (GAMP).
Senior Validation Specialist Jobs
By POINT Biopharma At Indianapolis, IN, United States
Experience in project management, test design, process flow, and troubleshooting.
5+ years relevant experience in validation and GMP.
Proficiency in manage multiple projects, setting priorities, and working in a fast-paced environment.
Experience using precision measuring instrument and electronic testing devices.
Excellent oral and written communication skills
Excellent organizational and interpersonal skills
Validation Manager Jobs
By C3J Therapeutics At , Marina Del Rey, Ca $120,000 - $150,000 a year
Participates in the generation and/or update of validation master plans and reports status to management.
Minimum 10 years’ experience in biotech/pharma Validation projects or equivalent combination of education and experience.
Knowledge of EU/international and US cGMP regulations for pharmaceutical guidelines, manufacturing operations, metrology requirements, validation procedures and practices.
Appropriately challenges the status quo and uses knowledge and experience to continuously improve work processes.
Coordinate qualification and validation trials and testing.
Ensures test methods supporting qualification or validations are scientifically sound, formally documented, and validated or compendial, as applicable.
Validation Lead Jobs
By Valeo At Auburn Hills, MI, United States
Lead, review, and ensure execution of test cases based on requirements, analyzing the test result discrepancies and resolving through debugging
Ensure alignment between global test facilities to ensure proper test planning, requirements, process, and reporting
Support test equipment development, commissioning, qualification, and integration
Support customer discussions, interpretation and creation of function definitions, test requirements, diagnostics, and safety requirements with customer
Minimum of six (6) years of professional test experience in power electronics or vehicle electrification at an OEM or Tier 1
Experience with Automotive protocols like CAN and UDS and Vector tools
Software Provider Validation And Support Specialist I
By North Carolina Department of Revenue At Wake County, NC, United States
Experience entering data with a high level of accuracy into databases/spreadsheets such as Microsoft Access.
Skilled at researching, analyzing, and interpreting data accurately with strong attention to detail.
Validate incoming forms for required specifications
Enter daily activity for required forms in the approval database
Print and distributing incoming forms for review
Deliver/pick up forms to other internal work groups
Validation Analyst Jobs
By Clario At , , Nj
Attending educational workshops and reviewing professional publications
Keeping informed of changes in the regulatory environment and/or regulatory requirements
Bachelor’s degree required in computer sciences, or equivalent and relevant work experience in a software product development environment.
Prior testing experience with pharmaceutical related software, preferred
Strong interpersonal and communication skills, both verbal and written
Ability to manage multiple tasks effectively & efficiently
Specialist Validation Engineer Jobs
By Amgen At , New Albany, Oh $107,134 - $129,381 a year
Proficient technical writing and presentations skills so as to collaborate with technical and senior management staff
Extensive experience in reviewing/approving validation protocols and reports in support of facility/information systems commissioning, qualification, and change administration
Provide technical support and domain expertise for commissioning, qualification, and validation maintenance activities in AOH
Coordinate actions with Manufacturing, Engineering, Quality, and Supply Chain business to ensure that the overall Amgen validation requirements are met
Expertise in information systems qualification for manufacturing facility
Experience with SAFe and traditional Agile methodology coupled with strong GxP experience
Qa Validation Jobs
By BioSpace At North Chicago, IL, United States
Knowledge of quality / compliance management as well as regulations and standards affecting API, Bulk Drug or Finished goods manufacturing preferred
Responsible for participating in implementation and maintenance of the effectiveness of the Quality System to meet all applicable regulatory requirements
Strong verbal and written communication skills
Solid problem solving and analytical skills
Solid interpersonal skills, including ability to negotiate/influence without authority
Ability to supervise junior or contract team members (prior supervisory experience preferred)

Are you looking for a challenging and rewarding role in the field of validation? We are looking for a Validation Specialist to join our team and help ensure the quality of our products and processes. You will be responsible for developing, implementing, and maintaining validation protocols and reports. If you have a passion for quality assurance and a keen eye for detail, this could be the perfect job for you!

Overview A Validation Specialist is responsible for ensuring that products, processes, and systems meet the required standards of quality and safety. They are responsible for creating and executing validation plans, performing validation tests, and documenting results. Detailed Job Description A Validation Specialist is responsible for developing, executing, and documenting validation plans for products, processes, and systems. They must ensure that all products, processes, and systems meet the required standards of quality and safety. They must also ensure that all validation plans are in compliance with applicable regulations and standards. Validation Specialists must be able to create and execute validation plans, perform validation tests, and document results. They must be able to analyze data and identify trends. They must also be able to troubleshoot and resolve validation issues. Validation Specialists must be able to communicate effectively with other departments and stakeholders. They must be able to work independently and as part of a team. Job Skills Required
• Knowledge of validation principles and processes
• Knowledge of applicable regulations and standards
• Ability to create and execute validation plans
• Ability to analyze data and identify trends
• Ability to troubleshoot and resolve validation issues
• Excellent communication skills
• Ability to work independently and as part of a team
Job Qualifications
• Bachelor’s degree in a related field
• At least 3 years of experience in a related field
• Knowledge of applicable regulations and standards
• Knowledge of validation principles and processes
• Ability to create and execute validation plans
Job Knowledge
• Knowledge of validation principles and processes
• Knowledge of applicable regulations and standards
• Knowledge of data analysis and trend identification
• Knowledge of troubleshooting and resolving validation issues
Job Experience
• At least 3 years of experience in a related field
• Experience in creating and executing validation plans
• Experience in analyzing data and identifying trends
• Experience in troubleshooting and resolving validation issues
Job Responsibilities
• Develop and execute validation plans for products, processes, and systems
• Ensure that all products, processes, and systems meet the required standards of quality and safety
• Ensure that all validation plans are in compliance with applicable regulations and standards
• Create and execute validation tests and document results
• Analyze data and identify trends
• Troubleshoot and resolve validation issues
• Communicate effectively with other departments and stakeholders
• Work independently and as part of a team