Validation Engineer/Specialist
3 weeks ago
VTI Life Sciences (VTI) is seeking forward-thinking and ambitious engineers looking to accelerate their career in the pharmaceutical, biotechnology and medical device industries. We offer an opportunity to help support our teams of industry subject matter experts and thought leaders while consulting with some of the biggest companies in the Life Sciences industries.
We are looking to staff a Cleaning Validation Engineer for a 9+ month contract with ourfor our client in the Greater San Diego area. This role will support pilot plant cleanability studies and tech transfer activities including support lab coupon studies to determine the cleanability new tech transfer products are compared to current products.
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.
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.
Execution of protocols by performing visual inspections, documentation (rinse samples by mfg).
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.
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.
: Qualifications:
5 -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 and
schedules.
Excellent team work skills communication and problem solving skills
Good communication
VTI Life Sciences strives to maintain and inspire professional excellence by providing Commissioning, Qualification, Quality Engineering, Automation and Validation Services to the Pharmaceutical, Biotechnology, Biologics and Medical Device industries. VTI offers professional development, training, competitive compensation, excellent benefits, 401K plus a stimulating and collaborative work environment. We are committed to providing exciting career opportunities in a work environment that values trust, respect, openness, teamwork, creative talent, enthusiasm and diligence.
As one of the leading global Commissioning, Qualification and Validation Services organizations, VTI is always looking for innovative, talented and experienced validation professionals for our multinational and global offices. We offer some of the best salary and benefit packages in the industry for our full-time/permanent employees as well as competitive hourly pay for our contractors. www.validation.org
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