Experience and Expertise:
It is expected to be a subject matter expert (5 years experience) in one or more of the following areas:
1. Validation of aseptic process simulations (Media Fills)
2. Validation of Steam sterilization (autoclave and steam in place)
3. Isolators and validation of decontamination cycles with vaporized hydrogen peroxide (VHP)
4. Cleaning validation / verification of equipment / surfaces used in drug products manufacturing
5. Experience or exposure to manufacturing of sterile injectable products
6. Environmental Monitoring Performance Qualification
7. Air Visualization / Profile Studies
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:
It is expected to coordinate activities with Production, Microbiology and Formulation
Developments as a Validation representative in assigned projects
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:
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
Nesco Resource offers a comprehensive benefits package for our associates, which includes a MEC (Minimum Essential Coverage) plan that encompasses Medical, Vision, Dental, 401K, and EAP (Employee Assistance Program) services.
Nesco Resource 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.
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It is expected to be a subject matter expert (5 years experience) in one or more of the following areas:
1. Validation of aseptic process simulations (Media Fills)
2. Validation of Steam sterilization (autoclave and steam in place)
3. Isolators and validation of decontamination cycles with vaporized hydrogen peroxide (VHP)
4. Cleaning validation / verification of equipment / surfaces used in drug products manufacturing
5. Experience or exposure to manufacturing of sterile injectable products
6. Environmental Monitoring Performance Qualification
7. Air Visualization / Profile Studies
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:
It is expected to coordinate activities with Production, Microbiology and Formulation
Developments as a Validation representative in assigned projects
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:
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
Nesco Resource offers a comprehensive benefits package for our associates, which includes a MEC (Minimum Essential Coverage) plan that encompasses Medical, Vision, Dental, 401K, and EAP (Employee Assistance Program) services.
Nesco Resource 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.