Job Description
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.
The ideal candidate will have a strong background in robotic engineering, automation system development, and bioanalytical data workflows, with experience in regulated environments. While the primary focus will be on vaccine-related assays and systems, the role may also support other modalities and methods across internal and external bioanalytical laboratories.
Key Responsibilities
Design, develop, and implement robotic automation work cellstailored to bioanalytical laboratory workflows, ensuring seamless integration with existing systems.
Lead thedevelopment, validation, and enhancement of LIMS and related software modulesto 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 applystatistical and machine learning modelsto 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 overseecomputer system validationsfor 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.
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U.S. Hybrid Work Model
Effective September 5, 2023, employees in office-based positions in the U.S. will be working a Hybrid work consisting of three total days on-site per week, Monday - Thursday, although the specific days may vary by site or organization, with Friday designated as a remote-working day, unless business critical tasks require an on-site presence.This Hybrid work model does not apply to, and daily in-person attendance is required for, field-based positions; facility-based, manufacturing-based, or research-based positions where the work to be performed is located at a Company site; positions covered by a collective-bargaining agreement (unless the agreement provides for hybrid work); or any other position for which the Company has determined the job requirements cannot be reasonably met working remotely. Please note, this Hybrid work model guidance also does not apply to roles that have been designated as "remote".
The salary range for this role is
$85,600.00 - $134,800.00This is the lowest to highest salary we in good faith believe we would pay for this role at the time of this posting. An employee's position within the salary range will be based on several factors including, but not limited to relevant education, qualifications, certifications, experience, skills, geographic location, government requirements, and business or organizational needs.
The successful candidate will be eligible for annual bonus and long-term incentive, if applicable.
We offer a comprehensive package of benefits. Available benefits include medical, dental, vision healthcare and other insurance benefits (for employee and family), retirement benefits, including 401(k), paid holidays, vacation, and compassionate and sick days. More information about benefits is available at https://jobs.merck.com/us/en/compensation-and-benefits.
You can apply for this role through https://jobs.merck.com/us/en (or via the Workday Jobs Hub if you are a current employee). The application deadline for this position is stated on this posting.
San Francisco Residents Only:We will consider qualified applicants with arrest and conviction records for employment in compliance with the San Francisco Fair Chance Ordinance
Los Angeles Residents Only:We will consider for employment all qualified applicants, including those with criminal histories, in a manner consistent with the requirements of applicable state and local laws, including the City of Los Angeles' Fair Chance Initiative for Hiring Ordinance
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Merck & Co., Inc., Rahway, NJ, USA, also known as Merck Sharp & Dohme LLC, Rahway, NJ, USA, does not accept unsolicited assistance from search firms for employment opportunities. All CVs / resumes submitted by search firms to any employee at our company without a valid written search agreement in place for this position will be deemed the sole property of our company. No fee will be paid in the event a candidate is hired by our company as a result of an agency referral where no pre-existing agreement is in place. Where agency agreements are in place, introductions are position specific. Please, no phone calls or emails.
Employee Status:
RegularRelocation:
VISA Sponsorship:
Travel Requirements:
Flexible Work Arrangements:
Not ApplicableShift:
Valid Driving License:
Hazardous Material(s):
Required Skills:
Assay, Assay, Automation, Bioanalysis, Biochemistry, Cell-Based Assays, Cell Culture Techniques, Clinical Judgment, Clinical Workflows, Data Analysis, Data Visualization, Detail-Oriented, Drug Metabolism, Ethical Compliance, GMP Documentation, Good Laboratory Practices (GLPs), Immunizations, Immunoassays, Immunotherapy, Laboratory Automation, Laboratory Informatics, Laboratory Information Management System (LIMS), Ligand Binding Assay, Liquid Chromatography-Mass Spectrometry (LC-MS), Management Process {+ 5 more}Preferred Skills:
Job Posting End Date:
09/10/2025*A job posting is effective until 11:59:59PM on the day BEFOREthe listed job posting end date. Please ensure you apply to a job posting no later than the day BEFORE the job posting end date.
Requisition ID:R363546