Support assigned protocols on the floor during execution.
Develops protocols (with the Responsible Engineer) as needed.
Reviews completed protocols for completeness, cGMP compliance and data acceptability – including those with significant technical issues.
Writes protocol final reports as required to assist Process Engineering as needed.
Tracks protocol execution status using the group’s protocol database as needed.
Trains manufacturing personnel on all validation procedures, protocols and concepts.
Reviews Critical Work Orders to evaluate validation impact.
Develops and manages studies to respond to Regulatory observations.
Contributes sections to Regulatory submissions.
Other tasks as determined appropriate by the Validation Manager.
Able to follow-up and resolve most (~85%) validation protocols with issues regardless of severity of issues.
Issue Assessment includes consideration of impact throughout the facility.
Able to plan and schedule validation projects at the site level. When projects fall behind schedule, manages the situation through resource allocation to completion.
Responsible for all validation activities within specific production area(s) as assigned.
Coordinates validation execution between all involved departments.
Able to lead a team during the execution of validation projects.
Seen as a resource and expert for validation issues by others throughout the company.
Fully proficient in the use of Lotus Notes, Word, Excel, Visio, Access, Project and Documentum. Able to learn new software packages as required.
Understands the operation of the majority (~85%) of process and utilities equipment
Has a solid understanding of the science behind validation. Can explain all validation concepts and practices to other employees.
Has basic understanding of validation practices industry-wide.
Has fair understanding of Regulatory expectations of validation.
AS in life science, engineering or equivalent. 8-12 years experience in pharmaceutical, biotech or related industries, OR BS in life science, engineering or equivalent. 4-7 years experience in pharmaceutical, biotech or related industries.