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Lab Operations Lead (Lab Systems Support)
Ref No.: 19-08963
Location: Summit, New Jersey
Sunrise System Inc. is currently looking for Lab Operations Lead (Lab Systems Support) in Summit, NJ with one of our top client.
 
Job Title: Lab Operations Lead (Lab Systems Support)
Job Id: 19-08963
Location: Summit, NJ 07901
Duration: 5 months
Position Type: Hourly contract Position (W2 only)
 
Brief Description
  • Leads and supports the administration and operations of computerized laboratory systems at multi‐use sites.
  • Experience in Pharmaceutical GxP regulated and non-regulated lab areas.
  • Implements, monitors and provides technical support of standalone laboratory systems and applications.
  • Proven track record of customer service, follow through, identifying issues, exploring resolutions, and implementing solutions that are timely, customer focused and in compliance with GMP and IT standards.
Responsibilities
  • Administration and support of Pharm DEV / QC / MFG / Biologics applications including standalone computerized laboratory systems
  • Ability to link bench-level lab system usage/operation with a corresponding enterprise lab system (i.e. HPLC? -? Empower).
  • Deliver support for GMP systems, installing new releases and patches (hot fixes), and performing upgrades.
  • Responsible for Pharm Dev / QC / MFG / Biologics application's system efficiency and technical support.
  • Perform routine backup operations, ensuring all required data files are successfully backed up to the appropriate media.
  • Repair and recover from hardware and software failures, coordinate and communicate with related vendor or individuals.
  • Prepare, review and update software/hardware qualification documents, change control, guidelines and SOPs.
  • Provides technical support to business groups through the use of troubleshooting procedures and testing.
  • Administration, support and maintenance of Laboratory computer systems adhering to service levels.
  • Manage project teams with emphasis on solutions to technical and compliance challenges in all phases of the System Lifecycle.
  • Oversee the Development/Review/Approval of IT Administrative Procedures.
  • Ensure resources performing IT activities are knowledgeable of and in tune with latest industry regulations and initiatives.
  • Provide input and guidance for technical strategy as it relates to all GMP computerized systems and address any compliance gaps.
  • Ensure all computerized systems remain in compliance post-production
  • Must have basic understanding of network architecture, system diagrams and interfacing components.
  • Combining strong technical ability with excellent communication and interpersonal skills to provide technical solutions that support the business
  • Liaising with laboratory equipment vendors to ensure laboratory and systems can be effectively and securely integrated into the Client computing environment.
  • If so required, manages the vendor to provide application solution fixes.
  • Troubleshooting client instrument workstation and information technology issues
  • Provides feedback and suggestions to the client for future improvements
Regulatory Responsibilities
  • Ensure all computerized systems remain in compliance post-production.
  • Required Competencies‐Knowledge, Skills, and Abilities: 
Knowledge, Skills & Abilities
  • Knowledge of cGMP, GXP, GAMP, SDLC regulations, including 21CFR part 11, and good documentation practices.
  • Advanced knowledge of pharmaceutical, manufacturing and laboratory systems and equipment that support Biologics and clinical manufacturing.
  • Ability to develop, delegate and motivate others including direct and indirect reports.
  • Strong written and verbal communication skills.
  • Excellent interpersonal skills with experience dealing with a diverse workforce.
  • Strong multi‐tasking ability in conjunction with proven organizational skills.
  • Ability to organize assigned tasks in a high paced environment and concurrently monitor tasks / assignments with others that may impact timely completion.
  • Ability to effectively manage multiple tasks and activities simultaneously.
  • Highly proficient computer skills in Microsoft Office Suite – Word, Excel, PowerPoint and Outlook with some knowledge in database systems.
  • Innate ability to learn new software, such as corporate intranet and enterprise business.
  • Ability to create and analyze meaningful metrics. 
Competencies
  • Professional Knowledge
  • Problem Solving
  • Team Player / Building Relationships
  • Multi‐tasking
  • Customer Focus
  • Highly Technical
  • Decisive
  • Ability to work and collaborate with Managed Services and other supporting functional areas with Client 
Experience and Required Skills
  • This position requires a minimum of a Bachelors in Science in Computer Science, Life Science, or
    equivalent industry experience, and 7+ years of relevant technical experience including supporting lab systems.
  • Minimum of 5 years' experience in FDA-regulated industry.
  • Minimum of 5 years' experience managing personnel and/ or projects.
  • Strong IT background and experience in laboratory and manufacturing operations.
  • Knowledge of cGMP in the pharmaceutical industry.
  • Excellent computer skills a must
  • Strong technical and problem-solving skills, strong verbal and written communication skills, and the ability to work independently.
  • Demonstrated understanding of Networking and IT Architecture
Non-technical
  • Experience in a high-availability, on-call environment
  • Customer focused, follow-through
  • Excellent customer service skills – interfacing with scientists, interfacing with vendors and other IT groups
  • Excellent organizational Skills - ability to manage time and multiple tasks
  • Excellent written and verbal skills
  • Strong problem solving skills
  • Strong GMP knowledge (standards, compliance, data integrity).
  • Able to write corresponding investigation documents
  • Problem solving, proven customer relationship and communication skills, and team behaviors
  • Knowledge of laboratory safety practices as defined by the Company and/or customer's site safety
  • Excellent Organizational Skills - ability to manage time and multiple tasks
  • Excellent written and verbal skills 
Contact
Sunny Rajput
Direct: (732) 272 0302 | Email: Sunny.R@sunrisesys.com
Or
Satya S
Direct: (732) 272.0262 | Email: Satya@sunrisesys.com