Project Manager for Manufacturing IT Systems/Pharma

Please call me at 408-675-8983 OR Email me : harika@cognateinc.com
 to discuss If you are qualified for this position & submit your resume in Word doc along with a brief cover letter and full contact info.
 
Role: Project Manager for Manufacturing IT Systems
Location: RTP, North Carolina
Duration: 6+ Months.
 
Management:
  • Interface and build collaborative partnerships with key site functions including Manufacturing, Technical Operations, Engineering, and Quality to deliver site goals and objectives.
  • Actively manage contractor activities to ensure work quality and safe practices to facilitation of contractor training.
  • Provide training or presentations on IT systems and tasks to site engineering personnel.
 
Performance: 
  • Maintain and support manufacturing automation LAN (Local Area Network) and VLANS.
  • Maintain and support all manufacturing automation servers, switches, routers, workstations and thin-clients.
  • Strong Server OS (operating Systems, MS-Win 2008, 2012, 2016) and VM (virtualization) knowledge.
  • Maintained 100% customer satisfaction for all technical support calls.
  • Provide hands-on detailed diagnostics/troubleshooting support for manufacturing, development, and utilities
 
Automated process control and monitoring systems
  • Support the design and implementation of sound engineering solutions for mitigating existing operational issues, drive continuous improvement, and introduce new technology in accordance with FDBU standards and cGMP regulatory requirements while following GAMP guidelines
  • Support capital projects with an automation element from conception, design and initial specifications through completion and turnover.
  • Develop/Revise User Requirement Specifications, Functional Specifications, Design Specifications, and Guidelines for new and existing control systems
  • Develop and execute validation protocols in compliance with IQ/OQ/PQ requirements and the Site Master 
 
Validation Plan strategy
  • Perform data back-ups of the DCS and BMS systems
  • Develop, revise and abide by standard operating procedures and automation engineering documents.
  • Lead, support, and perform investigations relating to complex manufacturing deviations and anomalies associated with automation systems and control system software in order to properly identify root cause and implement appropriate corrective and preventative actions to prevent reoccurrence
 
Other duties as assigned
Requirements Management:
  • Demonstrated leadership, interpersonal, technical aptitude, and problem solving skills.
  • Strong Project Management skills and be able to sell and justify projects.
  • Must be flexible and able to manage multiple priorities and projects
  • Must be results driven and goal oriented with the ability to manage risks
  • Excellent organizational, verbal and written communication skills with the ability to effectively communicate within cross-functional teams and to upper management
  • Ability to organize and present technical overviews to engineering staff, cross functional departments, and upper management
  • Maintains effective relationships across functional units gaining their trust and respect
  • Puts accomplishing the goals of the group ahead of accomplishing individual goals
  • Openly shares knowledge/information needed to accomplish a task or solve a problem
  • Exhibits professionalism and sets an example for others to follow
  • Self-starter and detail oriented
  • Ability to discuss normally encountered technical issues, both verbally and written, in a manner that is understood by non-technical personnel
 
Technical:
1. Controls (Knowledge on controls engineering should be fine)
  •  Understanding of DCS systems, i.e., DELTA-V.
  • Working knowledge in OSI-PI.
  • Basic knowledge of a variety of automation software applications, process control, Ladder
 
2. IT
  • Troubleshoot and repair hardware issues, like workstation motherboards, power supplies and peripherals.
  • Manage and troubleshoot Virtualization systems (Vmware ESXI/vSphere, MS-Hyper-V),
  • Provide Technical Support for the Windows/PC and teams
  • Document issues, bugs, and workarounds via SAS Notes and Defects.
  • Software & Hardware troubleshooting: POST Errors, malware, routers, switches
  • Software Management via Group Policy & SCCM services Manage print servers
  • Proficient computer skills with experience using MS Office software
  • Excellent documentation skills.
  • Strong technical aptitude for problem solving and data driven decision making
  • Good working knowledge of electrical systems, instrumentation and process controls
  • Basic knowledge of Oracle and SQL Server databases
 
3. Regulatory
  • Basic knowledge of IQ/OQ/PQ requirements in a regulated industry
  • Basic knowledge of FDA regulation 21 CFR Part 11
  • Knowledge of Data Integrity on FDA regulated environments
  • Knowledge of compliance industry regulations (cGMP, GxP, 21 CFR Part 11, GAMP, SOX and ISO)
 
Education and Experience
  • Bachelor’s Degree in Engineering
  • 10+ years relevant experience in process automation, IT systems, hardware and virtualization, preferably in cGMP regulated industry
  • Microsoft certified Engineer (desirable)
 
Certifications and Skills
  • SCADA-DCS (DeltaV,) including S88 batch, Ladder Logic (RSLogix, ControlLogix), OSISoft PI System, VBA, and VB.Net. (not mandatory)
  • Familiar with cGMP tasks/items such as: SOPs, MOC, incident  reporting (IR), and PSUSRs. 
  • Experience with virtualization systems (Vmware ESXI/vSphere, MS-Hyper-V), 
  • Microsoft certified Engineer  (desirable)
 
How to Apply:
If you are qualified for this position, please submit your resume in Word format along with a brief cover letter to APPLY NOW through this site.
 
 
About Us:
Headquartered in the heart of Silicon Valley, Cognate Inc. was established in 2005 and is a leading IT staffing and IT Consulting Company. Our focus areas includes Staffing and Consulting for Cloud Computing, Data Analytics, Big Data, Enterprise Security & Risk Management, Mobile Applications Development, IT Infrastructure Support, Enterprise Applications Support, E-Commerce, and Software & Platform as Service etc.

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