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: DYES00007003

Title: SUPPLY CHAIN BUSINESS ANALYST (SAP BO & Dodeca skills)

Location: Santa Clara, California

Duration: 10 Months+

Rate:$ 62/hr Max

 

Locals are highly preferred

 

Critical skills: 

Advanced Excel, Hyperion, SAP Business Objects. Basic Outlook and Windows.
Dodeca skills a plus. Must be able to communicate clearly - oral and written
Must be skilled in process mapping, process improvement, and identifying
ways to simplify and automate data reports.

 

SUPPLY CHAIN BUSINESS ANALYST, NOT IT. Critical skills: Advanced Excel,
Hyperion, SAP Business Objects. Basic Outlook and Windows. Dodeca skills a
plus. Must be able to communicate clearly - oral and written Must be skilled
in process mapping, process improvement, and identifying ways to simplify
and automate data reports.

 

 

Position ID: DYESFK00001581-1

Title: Validation Engineer 

Location: Canton, MA

Duration: 12 Months+ 

Experience Level: 10 + Years

 

Locals Preferred (Direct on Site work)

 

Job Description and Qualification for Validation Engineer.


Job Description:

*         Draft Qualification Protocols (IQ, OQ, and PQ) and/or provide
support during protocol review and approval 

*         Execute Qualification Protocols for Equipment and Utility System
(HVAC and CA) 

*         Setting up Temperature Data Acquisition equipment (KAYE Validator)

*         Perform Temperature Mapping studies for Environmental Chambers

*         Collect and Analyze data accumulated during temperature mapping
studies

*         Draft Summary Reports and applicable protocol amendments.

*         Author Summary Reports and applicable protocol amendments.

*         Execute Qualification Protocols and/or provide support during
protocol executions.

*         Write and investigate Discrepancies and Deviation Reports which
occurs during execution of the Qualification Protocols

*         Collaborate with Metrology department to assure that all
instruments related to equipment are in calibrated state during execution of
the protocols.

*         Provide support for day to day validation activities, associated
with validation life cycle

 

Qualifications:

*         BS/MS in chemical, biomedical, or mechanical engineering or
relevant discipline

*         3 to 5 years of experience working within cGMP regulated
production environment.

*         Must be familiar with Validation Life Cycle

*         Must have a working knowledge of cGMP type systems and practices
(21CFR Part 210 and 211)

*         Knowledge of Temperature Data Acquisition equipment (KAYE
Validator)

*         Strong technical skills - ability to operate equipment and setup
thermocouple wires

*         Strong technical writing and documentation skills are required.

*         Must demonstrate strong interpersonal and teamwork skills.

*         Authorization to work in Unites States is Required.

 

Position ID: DYESFK0001578-1

Title: Technical Writer (CSV & TrackWise)

Location: Boston (Canton) MA

Duration: 12 Months+ 

 

Locals Preferred (Direct on Site work)

 

Job Description Summary

Independently responsible for the efficient and thorough investigation of
process deviations and customer complaints, determination of root cause, and
initiation of corrective/preventative actions designed to adequately address
and correct the Quality related deficiencies identified during the
investigation process. Responsible to provide proactive corrections based on
noted trends to minimize the potential for repeat incidents that may lead
to, or result in, the issuance of Product Discards, Field Actions, or
Recalls. The position requires working with minimal supervision to manage
assigned investigations from initiation to completion.

 

 

Job Description

*       Responsible for ensuring compliance with relevant Standard Operating
Procedures, while gathering, analyzing and applying information from
internal and external sources in order to perform a risk assessment of the
impact each process deviation and complaint has on the product, process, and
patient health and safety.   
*       As part of each investigation, gathers information from all
necessary internal and external sources in order to evaluate the impact of
the deviation on previously manufactured product, as well as the risk to
future operations.
*       Prepares and analyzes manufacturing and laboratory analytical
historical data and uses methodical root-cause analysis tools to determine
root causes and effectively communicates the root cause to management.
*       The incumbent will need to properly assess the manufacturing or
analytical environment, independently conceive, and advise management on
appropriate corrective/preventative actions designed to mitigate Quality
deficiencies identified in the investigative process using industry accepted
analytical tools.
*       The individual in the position provides technical expertise to the
site to ensure that investigation corrective and preventative actions are
complete, thorough, accurate, and timely.
*       Updates and maintains all related enterprise quality management
systems in compliance with various governing procedures and policies as they
relate to investigations and performs trend analysis.
*       Works independently to comply with procedure driven guidelines
relating to Deviation and complaint investigations and makes decisions that
directly affect patient health and safety.
*       Demonstrates strong technical skills; provides technical assistance
to area supervisors or managers to solve complex problems.
*       Ensures that deadlines are maintained and closely monitors the need
for extensions to be administered in relation to Subsequent Actions and
Investigations in order to maintain compliance in this area.
*       Perform any other tasks/duties as assigned by Manufacturing
Management.

 

Requirements

*       BA/BS Degree in science field, e.g., Biology, Microbiology,
Chemistry, Pharmacy, etc. or equivalent combination of education and
experience.
*       At least three years' experience in a GMP manufacturing environment,
writing standard operating procedures and protocols and/or reports is also
required. Must be familiar with regulatory (FDA) requirements.
*       Good deductive and inductive critical thinking skills required.
*       Advanced writing skills required.
*       Candidate must possess strong interpersonal, written, and verbal
communication skills.  Incumbent must be able to interface positively with
Regulatory Agencies, vendors, and company departments. 
*       Proficient in MS Office programs, including Word and Excel.
*       Prefer candidates proficient with software programs TrackWise and
Documentum.

 

Position ID: DYES00010178

Title: Share Point with Office 365 Engineer

Location: North Chicago, IL

Duration: 6 Months+

 

Locals Preferred 

 

Description:

 6+ years of relevant, hands-on experience in managing, designing and
supporting Office 365 cloud technologies. 
 3+ years of relevant, hands-on experience supporting Office 365 ,
SharePoint Online, Teams, Onedrive, Yammer, Tenant,, Tenant, O365 Groups etc
in an Enterprise Environment. 
  Need experience in migrations of Teams, Yammer, Tenant,, Power Platform
services, content from O365 to O365 cloud 
  Need experience in Box Drive and migrations from Box to SharePoint and
Onedrive. 
  Experience working with Teams , Yammer, Tenant,, Power Automate , Power
BI, Power Apps. 
  Experience working with customers troubleshooting issues, providing
innovative and creative solutions to different challenges. 
  Experience working with Migrations from Cloud to Cloud. 
  Experience working with multiple teams in a huge collaboration
environment. 
  Experience in PowerShell scripting for Administrative or engineering
projects required. 
  Experience with Quest- Metalogix on demand and essentials , skysync,
Sharegate tool required. 
  Strong understanding of generally accepted system administration
methodologies, tools, and techniques, and desire to instill these practices
in both individual and teammates' work. 
  Experience working with Managed Service Providers preferred. 
  Understanding of networking and common datacenter infrastructure 
  Good written documentation skills and demonstrable experience of
documenting systems and procedures 
  Ability to communicate to all levels of audience and structure messages in
keeping with the listeners experience, background and expectation 
  Ability to adapt to a fast paced and ever evolving business and technology
landscape 
  Ability to collaborate and work with team members in and out of the
SharePoint environment spanning multiple geographic sites and various lines
of technology platforms 
  Ability to organize task and set priorities with minimal supervision while
raising awareness to issues or conflicts before it impacts deadlines and
goals 
  Experience with and wiliness to follow a strict change management and
incident tracking process 
  Excellent troubleshooting skills with a scientific approach to problem
investigation and resolution 
  Thorough understanding of working principles, and experience supporting
SharePoint, Nintex Forms/Workflows, Custom Solution deployments/support 
  Ability to design and create basic sites/solutions using OTB SharePoint
webparts/layouts/pages etc. 
  Lead SharePoint Engineering projects with minimal supervision. 

Experience in administrating a highly available multi-platform/site
SharePoint environment 
Requirements: 
  Required SharePoint knowledge: Office 365, SharePoint 2013, SharePoint
Online 
  Preferred - Experience in Microsoft Windows technology including 
  AD, DNS, Firewalls, Certificates and other network concepts. 

INTAKE CALL NOTES: 
Top 3 skills required: 
1. Office 365 Migration Experience ( O365 to O365 Cloud ) 
2. Architect experience with leading service migrations such as Teams,
Yammer, Tenant,, Power Platform 
3. Experience with Quest, Metalogix On demand and essentials 

 

 

 

Thanks & Regard's

Harry John
Dynamic Enterprise Solutions Inc
1801 Hicks Rd, unit A
Rolling Meadows, IL -60008
(847) 719-7902 /© 224-635-0898
Email: [email protected]



 

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