QC Automation Engineer/Scientist- Cell Therapy (Onsite- Warren, NJ)

About

We are seeking a QC Automation Engineer/Scientist- Cell Therapy for our global Pharmaceutical client. We are seeking an experienced contractor to support the development, qualification, and implementation of automated QC methods for cell therapy assays. This hands-on role will focus on designing, programming, and optimizing automation scripts and workflows for platforms such as Hamilton and Tecan, ensuring seamless technical transfer and compliance within a GMP environment. The successful candidate will collaborate with QC, analytical development, and automation teams to drive continuous improvement and operational excellence in automated QC systems.

This is a 40-hour per-week, 12-month contract (extensions possible), 100% onsite at the client s office in Warren, NJ.

This is a W2 role as a Stage 4 Solutions employee. Health benefits and a 401K are offered.

Responsibilities

• Develop, and qualify automated methods for Cell therapy QC assays (e.g., flow cytometry, cell-based assays, molecular-based assays, and cell viability) using automated liquid handlers and integrated platforms.
• Program and troubleshoot scripts for liquid handlers (e.g., Hamilton) and lab orchestration software (e.g. Cellario).
• Demonstrate that automated assay scripts developed from manual methods are comparable, robust, and fit for intended use through execution of defined development studies.
• Author development reports, work instructions, and supporting technical documentation in compliance with GMP requirements, and support associated validation activities as required.
• Drive troubleshooting and continuous improvement initiatives for automated workflows and systems.
• Drive training sessions and supporting documentation to support hand-off

Requirements

• Must have 3-5 years of hands-on experience in automation of biologic and Cell Therapy assays.
• Demonstrated proficiency in developing and programming automation scripts for liquid handlers (Hamilton, Tecan, or similar platforms) QX.
• Experience with integrated automation systems and lab orchestration tools (e.g., Cellario, HighRes BioSolutions).
• Strong problem-solving skills and ability to troubleshoot automated workflows and hardware/software issues.
• Familiarity with regulatory requirements for QC in the biopharmaceutical industry and experience supporting audits and inspections.
• Experience with programming languages (Python, Visual Basic, etc.) for automation workflows is preferred.
• Background in aseptic technique and bioprocess sample handling is preferred
• Experience in analytical method development for cell therapy or biologics is preferred.
• Bachelor's in Life Sciences, Engineering, or related field or Master's or Ph.D.

Application Instructions

Please submit your resume to our network at https://www.stage4solutions.com/careers/ (please apply to the QC Automation Engineer/Scientist- Cell Therapy role).

Please feel free to forward this project opening to others who may be interested.

About Stage 4 Solutions

Stage 4 Solutions is an equal-opportunity employer. We celebrate diversity and are committed to providing employees with an inclusive environment that is free of discrimination and harassment. All employment decisions are based on the job requirements and candidates qualifications, without regard to race, color, religion/belief, national origin, gender identity, age, disability, marital status, genetic information, or other applicable legally protected characteristics.