US_Validation Engineer III #: 22-06351
Company: HireTalent - Diversity Staffing & Recruiting Firm
Posted on: July 31, 2022
Job Description Job Title: US_Validation Engineer IIILocation:
Oceanside, CADuration: 28 MonthsJob Description
- Lead equipment, utilities, sterilization and/or autoclave
qualification due to equipment modifications for tech transfers,
Make-Assess-Release (MAR) or routine re-qualification
- 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 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
- 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
- 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
- Foster a positive safety culture in which no one gets hurt.
- 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
- Ability to manage and track validation progress in required
detail with data basis and schedules.
- Excellent team work skills communication and problem solving
- Good communication Work Environment/Physical Demands/Safety
- 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,
- BA/BS in Engineering or Life Sciences
Keywords: HireTalent - Diversity Staffing & Recruiting Firm, Oceanside , US_Validation Engineer III #: 22-06351, Engineering , Oceanside, California
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