7992 Validation Engineer III
Lead equipment, utilities, sterilization and/or autoclave qualification due to equipment modifications for tech transfers, Make-Assess-Release (MAR) or routine re-qualification activities.
Ensure the timely completion of Requalification as well as Project Team validation assignments.
Any deviations, anomalies or schedule impacting items are to be reported to site management.
This position provides trained technical resources for the development and execution of validation protocols in accordance with the Company and global procedures.
The person will maintain up-to-date training status in the Cornerstone (or equivalent) system.
Author and review qualification protocols, engineering change orders, SOP changes, Engineering commissioning and turnover packages.
Approval support of any qualification protocols will require approval of the site Head of Validation as well as Quality.
Review Planned/Unplanned events and provide initial assessment for validation lead.
Review of lifecycle documents for migration into new electronic system as well as for additional changes for MAR, Tech transfer.
Responsible for on-time completion of validation activities according to overall current manufacturing schedule.
Ensure coordination of Validation requirements with Quality, Manufacturing & Engineering.
Ensure the integration of environmental health, safety, and security into the business processes, systems and programs while reporting safety and environmental incidents including injuries, illnesses, and safety suggestions within one’s functional area. Foster a positive safety culture in which no one gets hurt.
Education and Experience:
BA/BS in Engineering or Life Sciences.
10 years of experience in the validation field of facilities, equipment and computers.
Expert in current validation requirements and FDA expectation of facility, equipment, and computer validation.
Establish and maintain good relationships with various site functional groups as well as external validation contractors and consultants.
Ability to manage and track validation progress in required detail with data basis and
Excellent team work skills communication and problem solving skills.
Work Environment/Physical Demands/Safety Considerations:
Work in standard office environment.
May on occasion work in clean room environment with large mechanical equipment, piping, and pumps connecting to tanks serviced by high-pressure steam, water and air together this creates a load environment.
Maybe exposed to hazardous materials.
Job descriptions are not intended, and should not be construed, to be all-inclusive lists of all responsibilities, skills, efforts, or working conditions associated with a job.
PLEASE NOTE: Our client has mandated COVID-19 vaccination for their workforce, all external personnel providing services to our client are required to comply with this requirement.