Validation Documentation Specialist Position Description
- The Validation Documentation Specialist participates in evaluating, developing, planning and implementing qualifications and validations of new equipment and processes. The Validation Documentation Specialist is responsible for writing, reviewing, and executing protocols and reports regarding the qualification of equipment for the purpose of improvements in current product processes, as well as supporting the validation of current and new processes from their early development stages through to implementation.
- Write, review, and assist in execution of IQ/OQ/PQ for GMP equipment.
- Assist Operations in developing new processes including sourcing of equipment and services for process installation and qualification.
- Develop Validation Studies for new product processes.
- Develop Validation Studies for revalidation of processes.
- Prepare and assist in the execution of validation and revalidation studies.
- Assist in writing change controls and reporting impacts of changes to products, processes or equipment.
- Assists in ensuring the Validation and Qualification Master Plans are current.
- Assist in developing cleaning validation protocols.
- Assist in creating standard operating procedures for new or current equipment as necessary.
- Other duties may be assigned as deemed appropriate by management.
- Four year Bachelor Degree in Engineering, Science or related field.
- 1 to 3 years of validation experience in a GMP/GLP environment.
- Strong analytical, oral communication and technical writing abilities.
- Demonstrate mechanical & computer aptitude.
- Strong understanding of GMP.
- Ability to fluently work with Microsoft Word, Excel, Minitab and other applicable software systems as necessary.
- Medical, Dental, and Vision Insurance
- 401K Plan
- Life and AD&D Insurance
Equal Opportunity Employer: Race, Color, Religion, Sex, Sexual Orientation, Gender Identity, National Origin, Age, Genetic Information, Disability, Protected Veteran Status, or any other legally protected group status.