Lab Operations Lead (Lab Systems Support)

Please send the resumes to careers@starkassociatesllc.com or

Contact: +1 848-300-0022

Job Title: Lab Operations Lead (Lab Systems Support)

Location: Piscataway,NJ

Duartion: 12+ Months

Note: Work on our W2

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 Celgene 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