Validation Engineer III

• Description:A Validation Engineer plans, implements, and monitors the validation strategy in highly regulated industries such as pharmaceutical or medical device manufacturing.
• 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 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.

AdditionalThis 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.

Job RequirementsEducation and Experience5 -7 years of relevant validation engineer experience. 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 andschedules. Excellent team work skills communication and problem solving skills. Good communication. 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.

The hiring range for this position is $70 to $80 per hour. The base pay actually offered will take into account internal equity, and may also vary depending on the candidate's geographic region, job-related knowledge, skills, and experience amongst other factors.

Harvest Technical Services is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, gender, gender identity or expression, sexual orientation, national origin, genetics, pregnancy, disability, age, veteran status, or any other federal, state, or local protected class.