What are the responsibilities and job description for the Sr. Validation Specialist position at Genesis Technical Staffing, Inc.?
Job Details
Job Description
Job DescriptionCompany Description
Genesis Technical has a contract opportunity for a Senior Validation Specialist in Birmingham, AL. Position is currently through the end of 2025 but could go longer.
Experience and Expertise:
- Are there any specific qualifications or technical skills required? It is expected to be a subject matter expert (5 years experience) in one or more of the following areas:
- Validation of aseptic process simulations (Media Fills)
- Validation of Steam sterilization (autoclave and steam in place)
- Isolators and validation of decontamination cycles with vaporized hydrogen peroxide (VHP)
- Cleaning validation / verification of equipment / surfaces used in drug products manufacturing
- Experience or exposure to manufacturing of sterile injectable products
- Environmental Monitoring Performance Qualification
- Air Visualization / Profile Studiee
- Typically a BS in engineering, chemistry or microbiology
- Knowledge on 21 CFR Part 211 and experience with FDA inspections
- Knowledge of Eudralex Annex 1 (current Version)
Collaboration and Project Involvement:
- Will the candidate interact with other departments? Yes, it is expected to coordinate activities with Production, Microbiology and Formulation Developments as a Validation representative in assigned projects
- If so, what level of responsibility will they have in managing projects, including protocol development and coordination?Establish validation requirements, develop and execute validation protocols analyzed data and prepare final summary reports. Depending on the project, the Sr Specialist may review and or approve work perform by entry level or peers in the department.
Protocols and Documentation:
- What specific standards and regulations should the candidate be familiar with when developing validation protocols and preparing summary reports?
- 21 CFR Part 211 and 210
- Audralex Annex 1
- ISPE cleanroom and environmental control guidelines
- IPEC for cleaning validation / verification
SUMMARY:
Develop validation protocols, execute pre approved test cases and prepare summary reports. Act as validation representative on assigned projects attending project meetings as scheduled by others Perform peer review of executed protocol and data generated by other specialist in the department. Act as subject matter expert on validation of sterilization processes such as autoclave cycles, SIP, dry heat dehydrogenation and VHP decontamination. Act as subject matter expert on aseptic process simulation requirements. Coordinate support from other departments (QC laboratories and or production personnel) when needed to complete validation tasks. Review validation procedures and policies as needed.
Genesis Technical Staffing, Inc., provides proven staffing solutions for the professional work environment. We offer more than 30 years experience in matching the most qualified engineering, design, and technical talent with the most innovative industrial, engineering, and technical companies. Our unique approach is based on integrity, honesty, and the sincere desire to foster mutually beneficial relationships. At Genesis, your success is our success.
Genesis provides equal employment opportunities to all employees and applicants for employment and prohibits discrimination and harassment of any type without regard to race, color, religion, age, sex, national origin, disability status, genetics, protected veteran status, sexual orientation, gender identity or expression, or any other characteristic protected by federal, state or local laws. This policy applies to all terms and conditions of employment, including recruiting, hiring, placement, promotion, termination, layoff, recall, transfer, leaves of absenc
Genesis provides equal employment opportunities to all employees and applicants for employment and prohibits discrimination and harassment of any type without regard to race, color, religion, age, sex, national origin, disability status, genetics, protected veteran status, sexual orientation, gender identity or expression, or any other characteristic protected by federal, state or local laws. This policy applies to all terms and conditions of employment, including recruiting, hiring, placement, promotion, termination, layoff, recall, transfer, leaves of absenc
Company Description
Genesis Technical Staffing, Inc., provides proven staffing solutions for the professional work environment. We offer more than 30 years experience in matching the most qualified engineering, design, and technical talent with the most innovative industrial, engineering, and technical companies. Our unique approach is based on integrity, honesty, and the sincere desire to foster mutually beneficial relationships. At Genesis, your success is our success.
Genesis provides equal employment opportunities to all employees and applicants for employment and prohibits discrimination and harassment of any type without regard to race, color, religion, age, sex, national origin, disability status, genetics, protected veteran status, sexual orientation, gender identity or expression, or any other characteristic protected by federal, state or local laws. This policy applies to all terms and conditions of employment, including recruiting, hiring, placement, promotion, termination, layoff, recall, transfer, leaves of absenc
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