Validation Specialist Job Description
Validation specialist
provides computer systems validation support and guidance for electronic quality management systems, spreadsheets, databases and other systems subject to 21CFR Part 11 requirements.
Validation Specialist Duties & Responsibilities
To write an effective validation specialist job description, begin by listing detailed duties, responsibilities and expectations. We have included validation specialist job description templates that you can modify and use.
Sample responsibilities for this position include:
Perform initial & periodical Computerized System validation for all GMP equipment at site (production & QC lab)
Define approaches for cleaning validation strategy
Collaborate with the other departments, within his/her respective areas of responsibility, for Change Management, for developing regulatory documentation, and for cleaning validation activities monitoring
Ensure all Design/Technology Transfer activities include collaboration with R&D, Engineering, Quality, Operations and other functions to develop manufacturing processes to ensure proper scale up, design verification and validation per IVD Design Control requirements
Investigate that manufacturing challenges are conducted properly and process improvements are evaluated and implemented through the change control management process
Lead multiple projects with minimal oversight
Review and approve risk assessment link to CSV
Performed routine Calibration & qualification activities
Verify contract terms, products, pricing, correct use of promotions, and the accuracy of contract information per company policies and procedures
Manage the completion of validation to service level agreements
Validation Specialist Qualifications
Qualifications for a job description may include education, certification, and experience.
Licensing or Certifications for Validation Specialist
List any licenses or certifications required by the position: PV, PQ, OQ, IQ, HEPA, CMO, CCSA, IC, UV, ITIL
Education for Validation Specialist
Typically a job would require a certain level of education.
Employers hiring for the validation specialist job most commonly would prefer for their future employee to have a relevant degree such as Bachelor's and Associate Degree in Engineering, Science, Chemistry, Education, Technical, Biology, Manufacturing, Computer Science, Biotechnology, Sciences
Skills for Validation Specialist
Desired skills for validation specialist include:
GMPs
21CFR Part 11
USP 1058 – and other relevant industry regulations and guidance
GMP
Cleaning validation
Utilities
Microsoft Suite
Templates
Workflows and approval process
FDA
Desired experience for validation specialist includes:
Bachelor’s degree in Engineering, Life Science or Physical Science
At least 1 year experience in in programming in C, C++ or other 3GL programming language
Basic knowledge in Linux, Advanced Interactive Executive (AIX) or Unix operating systems required
Responsible for executing validation studies
Bachelors or advanced degree in Natural/Life Sciences or related field
Five (5) years of experience in Molecular or Immunoassay diagnostics
Validation Specialist Examples
1
Validation Specialist Job Description
Job Description Example
Our growing company is searching for experienced candidates for the position of validation specialist. Please review the list of responsibilities and qualifications. While this is our ideal list, we will consider candidates that do not necessarily have all of the qualifications, but have sufficient experience and talent.
Responsibilities for validation specialist
- Compare information in the signed customer contract against the information in Big Machines Quote (BMI) to ensure the client will be billed correctly
- Ensure all required documents are complete and attached to opportunity to be validated
- Communicate all billing exceptions are added to the opportunity to ensure accurate customer setup and billing
- Confirm all systems are synced
- Verify the customer name, address, contact information, contracting Entity and country scope on the signed sales order form is the same as the billing account in Salesforce
- Confirm the required commissions and close won status is correct on the Opportunity in Salesforce
- Check the BMI Quote accuracy and appropriate levels of approvals are completed
- Verify the contract is legible, complete, signed, with correct date
- Responsible for verifying additional sales order forms have the correct customer name, bill cycle and core products by using the legal contracts on file
- Be able to communicate in writing what needs to be corrected if a contact needs to be rejected
Qualifications for validation specialist
- At least 1 year experience in program in C, C++ or other 3GL programming languages
- Basic knowledge in Linux, AIX or Unix operating systems required
- At least 1 year experience in Korn or bash shell scripting and Perl programming
- At least 1 year experience in problem determination and program debugging skills
- Working knowledge of IVD assay development and design/technical transfer
- Working knowledge of DOE and Statistical analyses
2
Validation Specialist Job Description
Job Description Example
Our growing company is hiring for a validation specialist. Please review the list of responsibilities and qualifications. While this is our ideal list, we will consider candidates that do not necessarily have all of the qualifications, but have sufficient experience and talent.
Responsibilities for validation specialist
- To set and implement standards on compliance topics
- To provide project management on compliance projects and meet project target
- To optimize compliance level according to current standards
- Write and/or review protocols, Final Reports and related supporting studies
- Participate in multifunctional teams for developing risk assessments
- Write periodic review for maintaining the validation status of manufacturing processes
- Write and or/collaborate in the developing of divisional and local validation procedures, within his/her respective areas of responsibility
- Participate in local and divisional teams for developing new projects
- Participate in divisional teams for the sharing and the harmonization of process validation approaches and for developing new strategies
- Support the design, documentation, and calibration of test systems in support of acoustics, power production, loads, thermal, and other measurement campaigns
Qualifications for validation specialist
- Ability to lead cross-functional technical projects
- Experience with use of Risk Assessment tools and the execution of Periodic Reviews
- Master degree in Biology/(Bio-)Engineering/Automation or equivalent
- Relevant experience in the pharmaceutical/agro-food industry
- Risk analysis thinking
- BS/BA in Engineering, Chemistry, or Life Sciences with a minimum of 1 year related experience within the field preferred
3
Validation Specialist Job Description
Job Description Example
Our company is searching for experienced candidates for the position of validation specialist. Please review the list of responsibilities and qualifications. While this is our ideal list, we will consider candidates that do not necessarily have all of the qualifications, but have sufficient experience and talent.
Responsibilities for validation specialist
- Support the development of new test & learn capabilities
- Hold reviews and utilize configuration management to capture documentation
- Under general supervision ensures cleaning and manufacturing processes are validated to required standards
- Works under general supervision to provide quality assurance oversight of commissioning and qualification activities for adhering to compliance with cGMP’s, regulatory, industry, and corporate requirements
- Arranging specialist services to qualify specialist equipment
- Supervising technicians, fitters and contractors as required when external support is utilised for qualification activities
- You will also represent the business in customer audits and regulatory inspections to demonstrate that we have compliant systems
- Creating/maintaining qualification related records, procedures, documents and drawings
- Engaging with project teams to help with selection, installation and commissioning of new equipment
- Provide general support to the Validation organization to meet department goals and objectives
Qualifications for validation specialist
- Liaise with internal customers, including Engineering, Facilities, Production, Print Room Pre-Production, IT, EHS and Project Management
- Perform or oversee validation/qualification activities, ensuring all involved are trained, aware of the specific requirements and resolve issues or conflicts as they arise
- Generate or assist in the generation, review or approval of Standard Operating Procedures, Corporate Policy Statements and other defined critical documentation concerning validation
- Perform or assist audits of vendor/supplier facilities to ensure regulatory, client and internal company requirements are met
- Contribute to the continuous development and improvement of relevant Quality systems, processes and procedures
- Knowledge or experience of validation systems and documentation
4
Validation Specialist Job Description
Job Description Example
Our innovative and growing company is looking for a validation specialist. To join our growing team, please review the list of responsibilities and qualifications.
Responsibilities for validation specialist
- Work on problems of diverse scope where analysis of data requires evaluation of identifiable factors while demonstrating good judgment in selecting creative/practical methods and techniques for obtaining solutions
- Work cross-functionally with internal and external teams
- Act as a champion for Quality Culture and ensure a safe working environment
- Responsible for ensuring and coordinating the support (planning, weekly validation, resources, cost) to RPCs or projects
- Responsible for VMP (Validation Master Plan)
- Review and approve protocols and certificates for IQ/OQ/PQ and check-lists
- Ensure correct and state of the art Validation approaches for change controls from Design Qualification step to the establishment of the Validation Summary report (which is final approved by the QA)
- Make sure that drawings and core files are updated
- Has developed at least one area of expertise and is recognized as such
- Bring expertise and coaching to streams
Qualifications for validation specialist
- Efficiently navigate through contracting systems
- Salesforce and Big Machines
- Act as a Subject Matter Expert on the contracting process within each application
- Provide insight on technical resolutions
- Maintain knowledge of internal pricing, discount and approval models
- Possess solid knowledge of MS Office products and general systems
5
Validation Specialist Job Description
Job Description Example
Our company is looking for a validation specialist. We appreciate you taking the time to review the list of qualifications and to apply for the position. If you don’t fill all of the qualifications, you may still be considered depending on your level of experience.
Responsibilities for validation specialist
- Ensure coordination with all key players (local QA, Global QA, C&M, production,…)
- Writes and facilitates Process Performance Qualifications and Continued Process Verifications
- Maintains validation schedule and assignments to meet quality and scheduled requirements
- Writes and revises SOPs and forms
- Open and clear communication with supervisor
- Lead periodic reviews on validated equipment, systems, and facilities
- Document thorough investigations and proposed CAPAs
- Kaye Validator system experience preferred
- Perform and manage change control while following a rigorous systems development lifecycle
- Follows GLP and Part 11 expectations for computer systems validation
Qualifications for validation specialist
- Working knowledge of contracting concepts and wide range of experience with contract types
- Understanding of the Salesforce workflow, views and dashboards
- Familiarity with Salesforce.com technical requirements, system configuration, and user requirements
- Solid understanding of sales and contract processes
- Must read, write, speak and comprehend the English language
- Operates under limited supervision