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Validation Engineer
4038 Avenida de La Plata Oceanside, CA 92056 US
Job 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 ones functional area. Foster a positive safety culture in which no one gets hurt.
Additional
- 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.
Job Requirements Education and 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 and schedules.
- 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.
- 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
Pay Rate Range: $75-95/hr depending on experience
Equal Opportunity Employer: We are proud to be an equal opportunity employer. We welcome and encourage applications from all qualified candidates regardless of race, sex, gender identity or expression, disability, age, religion or belief, sexual orientation, or any other characteristic protected by applicable laws and regulations. It is our policy not to discriminate against any applicant or employee, and we are committed to fostering a diverse, inclusive, and respectful work environment across all locations in which we operate. We believe that diversity, equity, and inclusion are fundamental to our mission and enhance our ability to serve clients globally. If you have a disability or require any reasonable accommodations during the application or interview process, please inform your recruiter or contact us directly so that we can explore the appropriate arrangements.
Fraud Alert: Candidate safety is a top priority at Planet Pharma. The industry has seen an increase in people falsely representing themselves as recruiters to gather personal information from job seekers. For your safety, do not provide sensitive data to anyone you have not spoken with thoroughly, never provide banking information during the application process and always double check the email address of the Recruiter to ensure it’s from an official Planet Pharma domain (@planet-pharma.com, @planet-pharma.co.uk, and @ppgadvisorypartners.com) and not a domain with an alternative extension like .net, .org or .jobs.
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