Job Description :
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 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

Requirements:
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