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*anc...@1pointsys.com <anc...@1pointsys.com>*





*1st*



*Position -- Manufacturing/Material Science Engineer *

*Duration: 10+ months*

*Location: Round Lake, IL*

*Job description – below*

Only USC / GC / GC EAD / H4 EAD / TN / Opt

 Plan, schedule, execute and lead Material Qualification project
assignments including evaluation, selection, validation and implementation
of new materials. Applies Quality Engineering principles to resolve
problems in a cross functional team environment. Essential Duties &
Responsibilities *Establish validation standards, develop testing
protocols, prepare equipment, document test results and maintain records
for later analysis. Coordinate with other personnel or
departments/functions who will be affected by testing. Compose reports and
make adjustments to equipment or processes that require improvement.

With minimal guidance, schedules and leads a team through the planning and
execution of a smaller project or defined piece of a larger project.
Coordinates and interfaces with Manufacturing, Logistics, Quality Control
and Supplier Quality groups to assure successful project execution. * Makes
recommendations and provides solutions using Quality Engineering
principles. * Ability to prioritize multiple tasks. * Employ appropriate
techniques and methods to successfully and independently execute materials
qualification projects. * Identify opportunities for improving existing
manufacturing processes by using tools such as FMEA, SPC, Design of
Experiments etc. * Make technical recommendations regarding equipment
qualification projects. Provide analysis/redesign of qualification
procedures and independently select techniques to solve problems. * Ability
to present a course of action to management and the project team with
minimal assistance using both written and verbal methods. * Contribute to
investigate sources of raw materials, coordinate technical analyses and
specifications, determine impact to manufacturing processes. * Recommend
and develop studies to determine critical raw material parameters and
quality attributes. Ensures alignment between Baxter and the suppliers
testing programs. * Apply statistical tools and risk assessment to analyze
and determine solutions to problems reflecting an understanding quality and
business requirements. * Work with technical teams to apply process
capability studies to understand and evaluate the manufacturing process. *
Contributes to regulatory submissions documents. Qualifications * Current
understanding of pharmaceutical industry regulations and trends in the
regulatory environment. * Strong interpersonal communications skills with
excellent technical writing abilities. * Demonstrated application of
engineering principles on projects. * Possess knowledge of GMP and
regulations related to Material/Equipment/Product Qualification. *
Proficient in Microsoft Office tools (Power point, MS Project, Excel, Word)
* Must have the following personal attributes: integrity and trust, work
ethic, sound judgment, intellectual honesty, pragmatism, courage and
conviction. * Must have passion to innovate and drive for solutions. * Must
display personal accountability for results and integrity. * Must display
eagerness to learn and continuously improve. * Must have uncompromising
dedication to quality. * Must have relentless focus on rapid and
disciplined action. * Must have respect for individuals and the diverse
contributions of all. Education and/or Experience * Bachelor's degree in
engineering or scientific discipline. * Quality Engineer Certification (QE)
preferred * Minimum of 3-5 years of experience in technical Quality,
Validation or related field in Pharmaceutical, Biotechnology or Medical
Device manufacturing. * Validation experience related to materials used in
manufacturing processes. Working Environment * Must be able to work in
controlled or clean room environments requiring special gowning. Will be
required to follow gowning requirements and wear protective clothing over
the head, face, hands, feet and body. No make-up, jewelry, contact lenses,
nail polish or artificial fingernails may be worn in these work
environments. * May be around moving equipment, laboratory instruments and
chemical reagents. * Must be able to work more than 8 hours a day or 40
hours a workweek as required. * Inside working conditions. * May be
required to travel for business reasons, e.g. training and meetings. * Will
have interaction with other people. * Pace may be fast and job completion
demands may be high. Physical Demand The overall physical exertion of this
position is sedentary work to light work. * May be required to use hand /
finger feel for computer use. * May be required to move or lift testing
equipment up to 20 pounds. * May be required to balance occasionally when
completing the following job duty (Gowning)."



*2nd *



*Position -- Infrastructure Engineer*

*Duration: 12+ months*

*Location: Houston, TX*

*Job description – below*

Only USC / GC / GC EAD / H4 EAD / TN / Opt



*Description:*
Responsible for providing technical support to infrastructure project
managers on infrastructure related projects. Develops design proposal
documents adhering to architectural standards and enterprise objectives.
Works closely with engineering teams to ensure detailed design
documentation is developed following the proposal and meets the need of the
project. Consults with various engineering disciplines to gain knowledge of
the technical standards in each area. Duties may include providing
technical direction to the project team, assisting in implementations and
testing. Each project will require different responsibilities as dictated
by scope that you will help the Project Manager to identify. However, you
will need to follow the IPMO Handbook Guidelines for Provisioning
Engineers. Please take time to fully go through this portion of the
handbook and understand what you will be responsible for as a PE.

Develop detailed Infrastructure Solution Designs to include configuration
and integration requirements for network, compute and storage elements.
•Collaborate with Infrastructure Project Managers, business analysts and/or
developers to ensure requirements gathered provide sufficient information
to complete detailed design. •Consult with technology groups (e.g.
application groups, DBAs, middleware, networking) to document platform
configuration in the solution and detailed designs. •Develops, implements
and monitors information systems policies and controls to ensure data
accuracy, security and regulatory compliance. •Ensures all architecture is
in full alignment with the business mission, strategies and processes and
supports the most efficient and secure IT environment to protect company
assets. •Investigates problems and consults with engineering teams for
solutions •Keep abreast of industry and technology trends. •Provide regular
status reports to others involved in the project. •Meet the project
requirements by delivering a quality solution, on time, and within the
planned budget. •May perform other duties as assigned by senior project
managers or management.

*Skill Set Details:*
8+ years as an engineer Experience with virtual serves, Network SAN
storage, end-user devices Only wanting candidates locate to Houston at this
time Experience working with internal customers Exceptional communication
skills. Team Player







*Anchit Bajpai*

*Technical Recruiter*

1 Point System LLC

Unit 103, 206 N College St, Pineville, North Carolina, 28134

*P*: *803-792-4353* *E* : *anc...@1pointsys.com <anc...@1pointsys.com>*

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