Lab analyst Jobs in Durham, NC

Position Summary

The Lab and Manufacturing Systems Support Analyst will provide IT support for KBI Biopharma’s laboratory and manufacturing environments and be the primary contact for issues related to Lab and Manufacturing Systems as they relate to IT. The position will require basic IT skills in relation to networking, hardware, databases, and operating system level knowledge. The Lab and Manufacturing System Support Analyst will support various technologies used throughout the lab and manufacturing environments including but not limited to : Empower, SoftMax Pro, Unicorn, MassLynx, Chemstation, SoloVPE, 32Karat, UV WinLab, PharmSpec, and Compass technologies. The position requires a working knowledge of the aforementioned lab and manufacturing systems and the ideal candidate should have prior experience in administration and or the end use of at least some including at least some of these systems and the instruments which they support.

The Lab Systems Support Analyst will be required to resolve routine requests that may include project / folder creation, system backups, account requests, etc.; as well as troubleshooting and resolution of complex issues related to Lab Systems. The position will require interaction with end-users to ensure that all end-user requests are fulfilled, and issues are resolved in a timely manner. The Lab Systems Support Analyst must be customer-focused and a good communicator.

The Lab and Manufacturing Systems Support Analyst will be required to serve as the Lead and / or Subject Matter Expert (SME) on projects relating to the installation, validation, and deployment of laboratory and manufacturing systems. The position requires basic knowledge of the Computer Systems Validation (CSV) process and will assist in the writing and execution of CSV deliverables as required. Previous knowledge and experience with Data Integrity remediation and support is a huge plus.

Position Responsibilities

Work within an agile team and framework

Resolve routine requests that may include project / folder creation, system backups, account requests

System Administrator providing Support to various technologies used throughout the lab and Manufacturing environments including but not limited to : Empower, SoftMax Pro, Unicorn, MassLynx, Chemstation, SoloVPE, 32Karat, UV WinLab, PharmSpec, and Compass technologies.

Be the Subject Matter Expert for Laboratory enterprise systems such as Empower and SoftMax Pro, UV WinLab.

Support and or Lead instrument inductions following established GMP processes

Support business priorities and be flexible to meet demand

Adhere to documented System Development Life Cycle as well as relevant regulations, policies, and standards

Lead and Support Identifying the root cause of issues and implementing permanent solutions to prevent future occurrences.

Support and Drive Implementing proactive monitoring to ensure early warnings and quick recovery

Effective communicator with all cross-functional areas regarding applicable IT tasks and deliverables

Support Lab and Manufacturing IT System Support team across multiple offices with a distributed workforce

Customer-focused and a good communicator

Position Requirements

3+ years of experience in a GMP regulated industry

Experience in system administration of Lab and Manufacturing system applications (i.e. : Empower, SoftMax Pro, UV WinLab, Unicorn)

Solid understanding of GMP applications

Basic knowledge of Computer Systems Validation (CSV) process

Knowledge of the IT system development life cycle and software quality assurance in a regulated environment

Knowledge of general networking concepts and IT best practices

Ability to work both independently and with teams at various levels in the organization

Strong communication skills, both verbal and written as well as capable of presenting the right level of information to management

Strong analytical and organizational skills

Salary : $76,400-$100,300

Salary range provided per current averages and expectations. The salary and job title for this opening will be based on the selected candidate’s qualifications and experience and may be outside this range. KBI has a robust total rewards strategy which includes an annual bonus structure for all employees, medical, dental, and vision coverage, paid PTO and holidays, Sabbatical program, 401K matching with 100% vesting in 60 days and employee recognition programs.