Automation And Robotic Engineering Scientist

Automation And Robotic Engineering Specialist

The PDMB Bioanalytics group at our West Point, PA site is dedicated to regulated pharmacokinetic (PK), immunogenicity, and molecular assay development and validation, supporting the development of small molecules, vaccines, and biotherapeutics. We conduct GLP and clinical sample analysis with a commitment to scientific excellence and regulatory compliance.

Position Summary: We are seeking a highly talented and motivated Automation and Robotic Engineering Specialist to lead the design, development, and implementation of advanced robotic automation and Laboratory Information Management Systems (LIMS) solutions within our regulated bioanalytical laboratory environment. This role will focus on creating innovative automation work cells and data management systems that enhance sample tracking, bioanalytical data analysis, and regulatory compliance.

Key Responsibilities:

• Design, develop, and implement robotic automation work cells tailored to bioanalytical laboratory workflows, ensuring seamless integration with existing systems.
• Lead the development, validation, and enhancement of LIMS and related software modules to support sample chain of custody, data analysis, and data management in compliance with regulatory standards.
• Collaborate with cross-functional teams and external partners to understand and optimize end-to-end sample tracking, testing, data analysis, archival, and submission processes.
• Manage day-to-day robotic automation and LIMS operations supporting method qualification, validation, and clinical study workflows, including user training, troubleshooting, and clinical data reconciliation.
• Develop and apply statistical and machine learning models to automate and improve bioanalytical data management and assay analysis.
• Define and implement data classification frameworks, including data architecture and taxonomies, to enhance data integrity and accessibility.
• Identify and integrate new capabilities for data handling and system interoperability, including electronic lab notebooks, clinical databases, and biospecimen management systems.
• Execute and oversee computer system validations for laboratory computerized systems and equipment, ensuring compliance with regulatory requirements.
• Serve as a subject matter expert during regulatory audits related to laboratory automation and computerized systems.
• Develop and maintain departmental SOPs and computer work instructions related to bioanalytical laboratory automation and data systems.

Education and Experience Requirements:

• Minimum: B.S. degree in Lifesciences, Engineering, Information Technology, or related sciences with 8+ years of relevant industry experience; or M.S. with ~4 years; or Ph.D. with 1+ years.
• Proven experience implementing or utilizing custom or commercial LIMS in regulated bioanalytical laboratories.
• Hands-on experience with scientific assays, including multiplex and single-plex bioanalytical assays supporting vaccines or drug development (e.g., immunogenicity, cell-based assays, PK, PCR serotyping).
• Demonstrated experience in robotic automation system design, development, and deployment within laboratory settings.
• Direct involvement in computer system validations.
• Strong analytical, problem-solving, and project management skills.
• Excellent verbal and written communication skills with a collaborative mindset.
• Familiarity with regulatory data standards and clinical/laboratory data transfer processes.
• Proficiency with data management tools such as Watson and LabMatrix.
• Ability to work independently and manage multiple priorities effectively.

Preferred Qualifications:

• Experience specifically with vaccines bioanalytical assays, particularly immunogenicity or molecular-based assessments.
• Experience developing and deploying end-to-end assay automation solutions using robotics and liquid handlers.
• Programming skills to automate data workflows and robotic system integration.
• Expertise in statistical analysis of laboratory data and development of machine learning algorithms.
• Experience driving improvements in regulated bioanalytical data workflows, either within LIMS or through statistical applications.
• Working knowledge of data standards such as CDISC and their application to bioanalytical data.
• Intermediate proficiency in Microsoft Office Suite.