Overview
On Site
Full Time
Skills
SOP
Turnover
Migration
Business Process
Reporting
Inspection
Training
Mechanical Engineering
Adobe AIR
Requirements Management
Pharmaceutics
Medical Devices
Manufacturing
Business Analytics
Business Analysis
Life Sciences
Management
SAP BASIS
Collaboration
Teamwork
Conflict Resolution
Problem Solving
Communication
Job Details
Responsibilities:
- Lead or support cleaning, 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 Cleaning Monitoring as well as validation team 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 OCN 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 Validation as well as Quality.
- Review Planned/Unplanned events and provide an initial assessment for validation lead.
- Review of lifecycle documents for migration into the new electronic system as well as for additional changes for MAR, Tech transfer.
- Responsible for on-time completion of validation activities according to the 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.
- This position provides resources for the controlled collection, assessment and reporting of scientific validation or study data in support of validation of processes. The data will be analyzed using algebraic and/or statistical methods to verify adherence to predetermined and approved process criteria. Reports will be written to communicate the outcome of the studies and/or validations.
- This position will provide sampling and inspection support for process equipment as part of the validation execution process. As such, the person must be trained on sampling and inspection procedures; and may be called upon to provide training for others as needed.
- Work in the standard office environment.
- May on occasion work in a 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. While this description is intended to be an accurate reflection of the job requirements, management.
- A Validation Engineer plans, implements and monitors the validation strategy in highly regulated industries such as pharmaceutical or medical device manufacturing.
- BA/BS in Engineering or Life Sciences.
- 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 schedules.
- Excellent teamwork skills communication and problem-solving skills.
- Good communication.
Employers have access to artificial intelligence language tools (“AI”) that help generate and enhance job descriptions and AI may have been used to create this description. The position description has been reviewed for accuracy and Dice believes it to correctly reflect the job opportunity.