Job description

Job Role: LIMS ENL Development Lead

Location: Branchburg, NJ (Currently Remote)

Duration: 12+ Months

KEY RESPONSIBILITIES:

· Experience Required: 5-10 years

· Strong development concepts of LIMS – LabWare (V6 / V7/V8)

· Detailed knowledge on Labware LIMS/ELN Architecture, Labware Database Structures, SAP Crystal Reports, Oracle - PL/SQL

· Hands on Experience in LIMS/ELN application development - Interfacing, Upgrade and validation

· Experience in Labware Modules like LIMS/ELN Stability, EM, Inventory, Storage Location Management, Instrument Interfaces, Lot, Sample Management for Clinical Trial & Manufacturing Domain

DETAILED SKILLS:

· Hands on experience on requirement gathering and configuration/development of Laboratory Information Management System (LIMS) e.g. LabWare (preferably V6-V7/V8 expertise)

· Experience in Labware Modules like LIMS Stability, EM, Inventory, Storage Location Management, Instrument Interfaces, Lot, Sample Management for Clinical Trial & Manufacturing Domain

· Ability to Solve all Technical Issues in Labware LIMS/ELN, including Interfaces to ERP, Label Printing Software, MDM and all modules

· Carried out relevant support activities like ensuring 24X7 application availability, Process Improvement & Automation, Impact analysis and replication of application issues et. al.

· Have hands on experience in SDLC and Agile model delivery & in ITIL and ITSM process integrations.

· Labware Certification.

· Labware Devtrack access

· Proven ability to lead and manage a team of

· 5- 10 consultants

OTHER RESPONSIBILITIES:

· Experience with risk based approaches for IT Application development.

· Ability to work independently, manage multiple priorities, and work in an unstructured environment.

· Excellent oral and written communication skills

· Knowledge of Pharma domain.

· Conduct GxP Analysis, Gap/Risk Assessment

· Knowledge of any scripting language is desirable

· Working on Proposals, Estimation and Presentations

KEY SKILLS/KNOWLEDGE:

· Strong foundation of Industrial Automation and Manufacturing IT Systems

· Good understanding of biopharmaceutical manufacturing including formulation, aseptic, drug substance processing and packaging processes.

· Experience with Agile Software development and JIRA

· Experience in ALM/eVal.

· Exposure of automation tools like Qtest and Tosca.

· Possesses expertise in Good Documentation and Good Testing Practices

Job Type: Contract

Pay: $45.00 - $50.00 per hour

Schedule:

• 8 hour shift

Work Location: Remote

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