Validation Engineer-(Bio pharmaceutical, Commissioning ) NO C2C
Company: Infotree Service
Location: Thousand Oaks
Posted on: May 3, 2021
|
|
|
Job Description:
Company DescriptionBio-TechJob Description***working on site 60%
of the time during COVID-19***The Validation Engineer will provide
technical support in all validation activities in alignment with
client Commissioning and Qualification Process (CQP) to ensure that
validation protocols are executed and documented in accordance with
cGMP good documentation and safety compliant practices. Also
support the commissioning strategy based on the URS and Quality
Risk Assessment for Automation and Equipment Systems (QRAES) to
validate equipment design while minimizing project cost and
schedule impact (risk-based approach). The Engineer will review
UserRequirementsSpecifications (URS) and work in partnership with
the Maintenance, Project Management, Engineering Technical Lead,
and Manufacturing to develop and oversee the operation and
reliability of equipment. In addition will work closely with
Quality Assurance (QA) for GMP compliance and provide broad
operational support to the manufacturing floor scientific,
technical interactions with partner organizations such as Process
Development (PD) and Clinical Process Engineering (CPE).
Development of validation protocols in line with CQP, Automation
Systems Delivery SOPs, and cGMP standards. Review the commissioning
reports and ensure that all verification exceptions have been
adequately addressed. Ensure safety during commissioning,
validation, maintenance and manufacturing activities. Collaborates
with Regulatory and Quality partners to assess change control
records and respond to regulatory questions and/or findings. Serves
as technical expert to lead or participate in projects to introduce
new products and/or advanced technologies into the plant. In
addition, the Validation Engineer will support periodic review of
manufacturing systems to ensure that they remain in a validated
state. The Engineer will support the projects in defining
strategies for quality systems verification and work with the
process development team to develop and document appropriate
practices for characterization. The validation engineer is a team
player prepared to work in and embrace a team-based culture that
relies on collaboration for effective decision-making. Relies on
instructions and pre-established guidelines to perform the
functions of the job. Works under immediate supervision. Typically
reports to a supervisor or manager.Education Requirement -
Bachelors with degree in engineering, chemical engineering
preferred.QualificationsEducation Requirement - Bachelors with
degree in engineering, chemical engineering preferred.Additional
InformationTop 3 Must Have Skill Sets:1. General knowledge on
Biopharmaceutical equipment operations and processes such as single
use technologies, Media / Buffer Prep solutions, Inoculation,
Bioreactors, Harvest, Chromatography and Tangential Flow Filtration
as well as Clean Utilities (intermediate level)2. General equipment
knowledge to perform basic troubleshooting of equipment failures or
malfunctions and/or the development of technical assessments.
(intermediate level)3. Experience in validation processes such as
execution of Installation / Operation / Performance qualification
documentation. (expert level)SummaryType: ContractFunction:
OtherSDL2017
Keywords: Infotree Service, Thousand Oaks , Validation Engineer-(Bio pharmaceutical, Commissioning ) NO C2C, Other , Thousand Oaks, California
|
Click
here to apply!
|
Didn't find what you're looking for? Search again!
Other Other JobsLicensed Health Insurance Agent - High Earning Potential Description: p span style font-weight: 400 Assurance, a Prudential company, is hiring Under 65 Health Insurance Sales Agents in your city. /span strong If you apos re already a Licensed Insurance Agent (more...) Company: ASSURANCE Independent Agents Location: San gabriel Posted on: 05/12/2021 Truck Driver CDL A - No Experience Needed! Description: p strong Looking to Get Your CDL or Just Graduated CRST can help /strong /p p /p p strong Were proud to announce the largest team driver pay increase in CRST history Join us and earn up to (more...) Company: CRST Location: San gabriel Posted on: 05/12/2021 Delivery Associate - Logistics LLC Description: p Are you interested in a new opportunity where you can work independently, make a difference in your community, and delight hundreds of customers every day Apply to be a Delivery Associate today. (more...) Company: Amazon Contracted Delivery Partners Location: San Gabriel Posted on: 05/12/2021 Information Security Officer & Physical Security Officer Description: Job Description This role has a central and key role in working with IT vendors on the Information Security of the bank, to ensure the companys information system assets are risk managed for regulatory (more...) Company: Makena Tech Solutions, Inc. Location: San Gabriel Posted on: 05/12/2021 Delivery Associate - Saba Couriers LLC Description: p Are you interested in a new opportunity where you can work independently, make a difference in your community, and delight hundreds of customers every day Apply to be a Delivery Associate today. (more...) Company: Amazon Contracted Delivery Partners Location: San Gabriel Posted on: 05/12/2021 Substitute Teacher Description: Date Posted: 9/1/2020 Application Deadline: Company: Rowland Unified Location: Rowland Heights Posted on: 05/12/2021 Teach English in China. No experience necessary. Apply now Description: apos Job Description: Calling all new and recent graduates EF English First is looking for enthusiastic go-getters to join our global team in China for the experience of a lifetime. Every year, candidates (more...) Company: Education First Location: San Gabriel Posted on: 05/12/2021 Construction Aide Description: Looking for a company that values your potential A job with AT T as a Term Splicing Technician can provide you with exactly that Take advantage of our paid training and wide range of career possibilities. (more...) Company: AT&T Location: San Gabriel Posted on: 05/12/2021 Teach English In China - No Experience Necessary Description: apos Job Description: Calling all new and recent graduates EF English First is looking for enthusiastic go-getters to join our global team in China for the experience of a lifetime. Every year, candidates (more...) Company: Education First Location: San Gabriel Posted on: 05/12/2021 Driver gig - Earn on your schedule Description: p Drive with Uber and earn money anytime it works for you. Driving is an easy way to earn extra, and it s totally flexible around your schedule. You decide when and how much you drive. /p p strong (more...) Company: Uber Location: San Gabriel Posted on: 05/12/2021 |
