Scientist - QC Systems and Equipment

Celltrion Branchburg, LLC•Branchburg Township, NJ

12h•$71,250 - $116,000•Hybrid

About The Position

This position provides in-depth support to the QC laboratories for new and existing laboratory equipment. This includes selection, implementation, maintenance, and continuous improvement of equipment within the QC laboratories. Serve as a technical lead on equipment implementation and validation projects and serve as a technical representative on project teams. Provides technical support in the diagnosis and resolution of QC equipment issues. Identify compliance and data integrity issues related to QC equipment and implement effective resolutions.

Requirements

Bachelor’s degree or higher in the sciences, engineering, related field, or equivalent work experience.
Proficiency with computer systems and laboratory software (Trackwise, Waters Empower, MODA, LabX, STARLims, etc).
Previous experience in a cGMP regulated environment related to QC laboratories or computer systems.
Must have good interpersonal skills and be able to work effectively and efficiently in a team-based environment.
Demonstrated learning agility, and ability to think creatively, try new ideas and apply learnings.
Highly motivated, enthusiastic to learn and share ideas and solutions effectively with management and colleagues.
Strong problem solving and analytical skills are required.
Must have excellent organizational, verbal, and written communication skills; able to efficiently communicate with cross- functional teams and management on recommended course of action, with minimal assistance.

Nice To Haves

Demonstrate strong oral, written communication and interpersonal interaction skills Strong organization and problem-solving skills.
Ability to build relationships across dimensions of difference, ask questions & invite others to contribute.
Speak up with ideas, concerns & to ensure safety of others.
Ability to take initiative, to be assertive, to lead by example and to build high-quality relationships.
Highly flexible, adapting to changes in priorities, requirements, and processes.
Working knowledge and understanding of computer system validation requirements.

Responsibilities

Act as business representative and contact SME for laboratory systems e.g., StarLIMS, MODA, NuGenesis, Empower, LabX.
Serve as a primary interface with customers including but not limited to QC, IDS, VTS, QA and vendors related to QC computerized systems.
Provide support, troubleshooting, and maintenance of QC lab systems (providing ‘on-call’ service, as needed).
Assist with the selection and implementation of equipment within the QC laboratories, as well as upgrades to existing systems.
Provides training, documentation and post- implementations support to users to the new application and or systems.
Lead site deployment and upgrade activities of QC laboratory systems.
Serve as a technical lead on QC computer system validation projects, driving the technical implementation and design/configuration of these systems required to achieve group and corporate objectives (also reviewing validation documentation and executing IQ/OQ/PQ protocols as needed).
Author and manage change control related to QC computer systems, as needed.
Ensure validated computerized lab systems are maintained in a manner compliant with corporate and regulatory requirements (including 21 CFR Part 11).
Identify compliance issues and process improvements related to the ongoing administration of QC computerized systems, implementing effective resolutions.