HI,

Hope you are doing great!

This is Harry from Dynamic Enterprise Solutions. We have urgent requirement
with one of our client's, please review below job description and let me
know your interest

 

Position ID : DYES00007905

Title: Senior Technology Engineer (Validation, QA) SDLC in a cGXP
environment 

Location: North Chicago, IL

Duration: 12 Months+

 

Locals Only



Client is seeking a developer who has programming, database and technical
support resolution knowledge. They should be someone who can handle
developing programs or scripts for any application as they come, comfortable
with databases, and who can easily pick up system and move forward with
little direction. They should be able to be independent and take direction
as well as do support when needed.

 

Purpose: 
Describe the primary goals, objectives or functions or outputs of this
position. 
Work collaboratively with technology and business groups to conceive,
design, engineer, implement and support data, software, and technology
solutions that solve significant scientific or business problems.
Investigate, identify, and implement state-of-the-art technology platforms
that drive productivity and efficiency gains in own function and throughout
multiple business areas. Contribute to advancement of technology in area of
expertise. Develop productive collaborations and communications with other
groups across multiple disciplines. 



Responsibilities: 
List up to 10 main responsibilities for the job. Include information about
the accountability and scope. 

1.      Understand and adhere to corporate standards regarding applicable
Corporate and Divisional Policies, including code of conduct, safety, GxP
compliance, data security, and the software development lifecycle. This
includes validation, change control, CAPA and other cGXP policies and
procedures. 
2.      Conceive, design, engineer, and implement data, software, or
technology solutions by studying information needs; conferring with users;
studying systems flow, data usage, and work processes; investigating problem
areas; Routinely demonstrate initiative and creativity in developing
technology solutions. 
3.      Serve as technical expert or lead projects/programs and technical
staff to develop, test and implement significant new products, or
operational improvements or devise new approaches to problems at the
division/business unit. 
4.      Analyzes and resolves technical problems using analytical
problem-solving methods/techniques and associated tools/devices. 
5.      Contribute to advancement of own function by studying
state-of-the-art tools, techniques, and computing equipment; participate in
educational opportunities and professional organizations. 
6.      Demonstrate high proficiency across a wide range of technologies and
platforms related to software design and development, programming languages,
data integration, data warehousing, data analysis and visualization tools,
data storage, network connectivity, and virtualization/cloud environments. 
7.      Highly autonomous and productive in performing activities, requiring
only minimal direction from or interaction with supervisor. Accountable for
total project scope, budget, completion within budget constraints and
scheduled completion date. Accountable for successful and timely completion
of all tasks/projects under direct and matrix control. 
8.      May initiate new areas of investigation that are meaningful,
reliable, and can be incorporated directly into a scientific or business
activity. 
9.      Provides technical leadership and mentors less experienced staff in
in planning, methods, procedures, standards and best practices. Maintains
relationships with affiliates, subsidiaries, and vendors in accordance with
Client Values, Vendor Management Office, and Purchasing to further the
mission, vision and goals of the organization. 
10.     Adapt work schedule to support the business operations. This
includes maintenance works, replacements, upgrades, migrations and other
changes to systems in production during off-peek ours. This might require
working overtime, overnight or on weekends and holidays and to be on call
during the off hours to attend any emergency or critical problem that may
arise with the systems in the area of responsibility. Work may be required
inside a pharmaceutical products manufacturing facility that require special
restriction conditions. Systems used to support the business operations must
be supported 7 days a week and 24 hours a day continuously. 




Qualifications: 

List required and preferred qualifications (up to 10). Include education,
skills and experience. 

*       Bachelor's degree in Computer Engineering preferred or equivalent
plus 4-7 or more years technical experience, or Master's degree plus 5 or
more years' experience or sufficient experience to demonstrate technical
equivalency. 
*       Experience: 

1.      Experience with global scale manufacturing systems
(Documentum/LIMS/MES/PCS, OSI/PI, Track & Trace) development, integration
and support 
2.      Knowledge and experience with all phases of SDLC in a cGXP
environment 
3.      Knowledge and experience with all phases of systems validation 
4.      Highly skilled with shop floor devices infrastructure application
integration support (PC's, printers, barcode scanners, serial devices,
manufacturing testing equipment) 
5.      Highly skilled in architecture infrastructure application
integration (network, servers, databases) 
6.      ITIL expertise including performance metrics development and
management. 

*       Total combined experience required: BS + 10; MS + 8; PhD + 0 
*       Key Stakeholders: 
*       Global BTS Teams, Global Validation, Site BTS, Manufacturing,
Validation, QA, Engineering and Software Vendor 

a.      Years of experience/education/certifcations required: Bachelor's
degree in Computer Engineering preferred or equivalent plus 4-7 or more
years technical experience, or Master's degree plus 5 or more years'
experience or sufficient experience to demonstrate technical equivalency. 
b.      What are the top 3 skills/requirements this person should have? 
c.      Exp with SQL, 
d.      Nava Scripting 

*       Soft Skills: 

a.      Team driven person 
b.      Highly adaptable 
c.      Quick Learner 
d.      Self Starter 
e.      Ability to hit the ground running 




 Thanks & Regards 

Harry John

Dynamic Enterprise Solutions Inc 

1801 Hicks Rd, unit A

Rolling Meadows, IL -60008

 (847) 719-7902 / (847) 874-7274
C 224-635-0898

Email:  <mailto:[email protected]> [email protected]

URL: http//  <http://www.dynamic-enterprise.net/> www.dynamic-enterprise.net

 

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