QC Lab Systems & Equipment Validation Lead

Celltrion Branchburg; Branchburg Township (NJ); Hybrid; USD 71.000 - 116.000; Vollzeit

Benefits dieser Stelle

Paid time off

Medical, dental, and vision insurance

Life insurance

Company retirement plan

Wellness programs

Disability benefits

Zusammenfassung

Celltrion Branchburg, LLC is seeking a QC Equipment and Laboratory Systems Specialist to support QC laboratories, lead equipment implementation, and ensure data integrity in a regulated environment. The role requires a bachelor’s or higher in the sciences, and expertise with key QC software.

Ideal candidates will lead validation projects, coordinate with QC, QA and vendors, and maintain compliant computer systems while collaborating across teams. Hybrid work options may be available.

Qualifikationen

• 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, LabVantage, 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 in a team-based environment.
• Demonstrated learning agility and ability to think creatively and apply learnings.
• Highly motivated, enthusiastic to learn and share ideas with management and colleagues.
• Strong problem solving and analytical skills are required.
• Excellent organizational, verbal, and written communication skills; cross-functional collaboration.

Aufgaben

• Act as business representative and SME for laboratory systems (e.g., LabVantage, MODA, NuGenesis, Empower, LabX).
• Serve as a primary interface with customers including QC, IDS, VTS, QA and vendors related to QC computerized systems.
• Provide support, troubleshooting, and maintenance of QC lab systems (on‑call as needed).
• Assist with selection and implementation of equipment and upgrades in QC labs.
• Provide training, documentation and post-implementation support to users.
• Lead site deployment and upgrade activities of QC laboratory systems.
• Lead QC computer system validation projects and drive technical implementation per IQ/OQ/PQ.
• Author and manage change control related to QC computer systems.

Kenntnisse

Strong problem solving

Interpersonal skills

Teamwork

Learning agility

Communication skills

Analytical skills

Organizational skills

Verbal and written communication

Ausbildung

B.S. or higher in science

M.S. in science

B.S. with 3+ years experience

M.S. with 2+ years experience

Tools

Trackwise

Waters Empower

MODA

LabX

LabVantage

Jobbeschreibung

Celltrion Branchburg, LLC is seeking a QC Equipment and Laboratory Systems Specialist to support QC laboratories, lead equipment implementation, and ensure data integrity in a regulated environment. The role requires a bachelor’s or higher in the sciences, and expertise with key QC software.

Ideal candidates will lead validation projects, coordinate with QC, QA and vendors, and maintain compliant computer systems while collaborating across teams. Hybrid work options may be available.