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.
• 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
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.
• Professional Knowledge
• Problem Solving
• Team Player / Building Relationships
• Customer Focus
• Highly Technical
• Ability to work and collaborate with Managed Services and other supporting functional areas with Celgene
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
• - 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