*Hi,*
* *
*Please take a look at the below requirement details and let me know if you
are comfortable with it along with your updated resume*
* *
*1. **Linux + C++ Developer- 1 position- Milwaukee, WI– Fulltime on
Birla soft Payroll- Salary USD 80-90K/Yr*
· 5+ year Strong C++, Linux
· OO Design and Development
· Nice to have : Agile exposure , Prior GE (CT/PET/MR) experience
· DOORs, Clearcase, Clearquest
2. *VMWare Admin with Linux - 1 position- Milwaukee, WI– Fulltime on
Birla soft Payroll- Salary USD 80-90K/Yr (**GE Healthcare exp. mandatory)*
*Skills on Priority (Rating):*
o Installation, configuration, and Support of VMware solutions.
o VCloud Director, vSphere, vCenter Lab Manager
o Scripting and automated configuration (Power Shell, Orchestrator)
o Virtual networks Fencing, standard/distributed switches
o Linked Clones, Thin Provisioning, Consolidating Linked VMs
o ESX Command-Line Troubleshooting Methods using SSH access
o Porting VM between different VMware Products and Versions
o P2V & Consolation (Both Physical and VM)
o Other industry Hypervisors & Self-service VM Products
o Installation and Administration of Linux, and windows servers OS
o Troubleshooting performance problems
o Scripting and automated configuration
o OS Customization
o AD, Group Policy
**
*Relevant Exp. 5-6 yrs*
*Roles & Responsibilities:*
o Good communication skills and willing to work with different team
across the organization.
o Understanding the users requirements and drive to achieve it.
o Should have minimal hardware knowledge and understand of HP ILO 2
concepts.
o The candidate may require to work in long hours and weekends depends
on the business requirements
o Should possess experience in coordinating with OEM vendors (VMware and
HP).
o Experience in coordinating with teams for scheduling periodical
maintenance on all hardware
* *
3. *Validation Manager - 1 position- Salt lake City, UT – Fulltime on
Birla soft Payroll- Salary USD 80-90K/Yr *
*Requirements: *6-7 years of industry experience within medical device /
pharma industry or FDA regulated environment preferred
· 2 years of experience in validation management and supervisory
roles.
· Demonstrated proficiency in application of 21 CFR Parts 11 & 21
CFR Part 820 / 210 / 211
· Basic understanding of
§ European Regulations (EMEA)
§ Canadian Regulations (Health Canada)
§ Japanese Regulations (Ministry of health - MOH)
§ UK Regulations (MHRA)
§ Australian Regulations (TGA)
· Experience in developing, executing, monitoring, and managing
computer system validation activities in GMP regulated industry.
· Strong verbal and written communication skills, including
presentation and facilitation skills.
· Extensive experience negotiating with and influencing internal
and external team members
· Strong leadership skills with excellent judgment, willingness to
make decisions and ability to push back on others (i.e., say no) when
appropriate.
*Responsibilities:*
· Provide guidance and direction to systems owners and technical
teams in the development and execution of computer system validation.
· Oversees the completion of projects through the development and
approval of validation schedules, project plans, master plans, validation
protocols and reports for systems that may be complex in nature to support
the healthcare industry.
· Manages the development, implementation and execution for
validation protocols and procedures to ensure computer system validations
meet appropriate international regulatory agency validation requirements
and internal company standards.
· Manages the activities of assigned validation and testing
personnel to ensure the quality of completed work.
· As required, prepares documentation for regulatory submissions
and supports during external or internal regulatory inspections/audits.
· Performing risk assessments from a healthcare perspective for
computer systems or IT/IS infrastructure (Ex. Networks, Datacenter and
Server).
· Works closely with other departments to insure compliance is
maintained across the enterprise.
· System change control compliance management – the review and
assessment of system change control documents for regulatory impact and
executing the resulting required validation tasks.
· Designs, implements, and maintains training programs for
validation processes and equipment.
*Thanks & Regards*
*Ahmed*
*Software Technology Labs Inc.*
*12421 Bob White Lane, Plainfield, IL 60585
Direct: 209 315 8595 | Phone: 406 888 8100 | **
ah...@softwaretechnologylabs.com* <ah...@softwaretechnologylabs.com>* **|***
*Office Locations: Los Angeles, CA | San Jose, CA | India
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