- Lead or support cleaning, equipment, sterilizationand autoclave qualifications
- Ensure the timely completion of cleaning monitoring as well as validation team assignments.
- Provide swab, rinse and visual inspection for cleaning validation sampling
- Perform temperature mapping for CTU and SIP
- Author and review qualification protocols, engineering change orders, SOP changes, engineering commissioning and turnover packages.
- Review planned/unplanned events and provide initial assessment for validation lead.
- Review of lifecycle documents for migration into new electronic system
- Responsible for on-time completion of validation activities according to the overall current manufacturing schedule.
- Ensure coordination of validation requirements with Quality, Manufacturing & Engineering.
- 7+ years of relevant validation engineer experience
- BA/BS in Engineering or Life Sciences
- Experience in cleaning validation sampling (swab, rinse and visual inspection)
- Have experience with autoclave qualification
- Have experience performing temperature mapping for CTU and SIP
- Have the ability to coordinate with other groups for sample timing,
- Experience using electronic systems for document management
- 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
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Validation Engineer-Cleaning Validation/Temperature Mapping - California, United States - VTI Life Sciences
Description
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 Validation Engineer with strong experience in cleaning validation and temperature mapping for a 9+ month project with our biopharmaceutical client in the Greater San Diego area.
Responsibilities:
VTI Life Sciencesstrives 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.VTIoffers 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,VTIis 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.
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