ZipRecruiter

Log In

1

Senior Labware Lims Developer Jobs in New York (NOW HIRING)

MSD

Sr. Specialist, Technical Support

Rahway, NJ · On-site

Perform investigations, change requests, and ensure compliance with engineering documentation ... Knowledge of integrated software applications, including SCADA, MES and LIMS systems, in support of ...

previous page

Showing results 41-60

All JobsLabware Lims Developer JobsSenior Labware Lims Developer JobsSenior Labware Lims Developer Jobs in New York

Senior Labware Lims Developer information

What are the typical collaboration points between a Senior Labware LIMS Developer and laboratory staff during system enhancements?

A Senior Labware LIMS Developer frequently collaborates with laboratory staff to gather requirements, validate workflows, and ensure that system enhancements align with actual lab processes. This involves conducting user interviews, participating in design reviews, and providing training or support during user acceptance testing. Regular communication helps bridge gaps between technical capabilities and lab needs, resulting in solutions that improve efficiency and data integrity within the lab environment.

What are the key skills and qualifications needed to thrive as a Senior Labware LIMS Developer?

To thrive as a Senior Labware LIMS Developer, you need expertise in software development, database management, and extensive experience with LabWare LIMS, often supported by a degree in computer science, bioinformatics, or a related field. Proficiency in LabWare scripting, SQL, JavaScript, and familiarity with laboratory workflows and compliance standards like GxP are typically required, along with relevant certifications. Strong analytical thinking, problem-solving, and effective communication skills enable you to translate complex lab requirements into robust technical solutions. These competencies are essential for delivering reliable, scalable LIMS implementations that support scientific operations and regulatory compliance.

What is the difference between Senior Labware Lims Developer vs Labware Lims Analyst?

AspectSenior Labware Lims DeveloperLabware Lims Analyst
CredentialsTypically requires a degree in life sciences, computer science, or related field; certifications in Labware LIMS are commonOften holds similar degrees; certifications in Labware LIMS may be preferred but less emphasized
Work EnvironmentFocuses on software development, customization, and integration within laboratory settingsPrimarily analyzes data, supports system users, and ensures data integrity in labs
Employer & Industry UsageUsed by biotech, pharma, and clinical labs for system development and maintenanceEmployed in similar industries for data analysis and system support roles

The Senior Labware Lims Developer primarily focuses on developing and customizing LIMS software, while the Labware Lims Analyst concentrates on data analysis and system support. Both roles require relevant certifications and work within laboratory environments, but their core responsibilities differ significantly.

What is a Senior Labware LIMS Developer?

A Senior Labware LIMS Developer is an experienced software professional who specializes in designing, developing, and maintaining Laboratory Information Management Systems (LIMS) using LabWare software. They work closely with laboratory staff and IT teams to customize and optimize LIMS solutions, ensuring efficient data management and compliance with industry regulations. These developers often lead complex projects, troubleshoot technical issues, and mentor junior team members to enhance laboratory workflows.
What are the most commonly searched types of Labware Lims Developer jobs in New York? The most popular types of Labware Lims Developer jobs in New York are:
What are popular job titles related to Senior Labware Lims Developer jobs in New York? For Senior Labware Lims Developer jobs in New York, the most frequently searched job titles are:
What job categories do people searching Senior Labware Lims Developer jobs in New York look for? The top searched job categories for Senior Labware Lims Developer jobs in New York are:
What cities in New York are hiring for Senior Labware Lims Developer jobs? Cities in New York with the most Senior Labware Lims Developer job openings:
Senior Labware Lims Developer jobs near you
Infographic showing various Senior Labware Lims Developer job openings in New York as of June 2026, with employment types broken down into 74% Full Time, and 26% Contract. Highlights an 100% In-person job distribution.

Sr. Manager IT Quality Assurance Validation Computerization Systems

Lynkx Staffing LLC

Saddle Brook, NJ • On-site

Full-time

Re-posted 7 days ago

Job description

Senior Manager IT Quality Assurance Validation Computerization Systems Allendale, NJ Lynkx Staffing LLC specializes in placing talented professionals in the Biotechnology, Pharmaceutical and Medical Devices IT & Human Resources disciplines in New Jersey. The Senior Manager IT Quality will be responsible for supporting the Computerized System Project Teams in the review and QA approval of system validation and infrastructure qualification documentation and protocols, in accordance with FDA regulations/guidelines, 21 CFR Part 11, EU Annex 11, GAMP5, ICH Q10 and latest industry practices. The incumbent will also be responsible for QA oversight of all GxP computerized system activities implementation projects for the company to ensure compliance with regulatory requirements. The scope includes working with multi-functional teams on system implementations, problem resolution, and process improvement projects. Assist in maintaining and, where applicable, improving the effectiveness of the computer system validation and data integrity program. Will participate in the execution of highly complex and specialized projects and must be innovative and practical in project validation problem-solving.
  • Provide QA oversight and assurance that all GxP computerized system implementation and validation activities are executed in accordance with internal procedures and standards and meet all regulatory requirements.
  • Contribute expertise and provides guidance in 21 CFR Part 11, GAMP5, and EU GMP Annex 11 requirements and data integrity principles and requirements as well as participates in assessments.
  • Develop and evaluate quality processes and system standards to ensure compliance with company standards and governmental regulatory requirements.
  • Work closely and collaboratively with various business partners including Information Technology and system owners to effectively and efficiently implement new computerized systems, system upgrades, or system modifications.
  • Review and QA approve various types of system validation and infrastructure qualification documentation, including but not limited to, Master Plans, User Requirements and Functional Requirements Specifications, Design Specifications, IQ, OQ, PQ, Traceability Matrix, Validation protocols and reports.
  • Coordinate implementation validation/qualification strategies and serve as the subject matter expert.
  • Present project status reports to management as well as project teams.
  • Review Change Control requests and assess impact to validation. Support the necessary computerized system validation activities for changes.
  • Perform gap analysis of validation documentation, systems and practices. Communicate identified gaps including recommending and implementing corrective actions and improvements.
  • Participate in supplier site Validation Assessments/Audits and assist to troubleshoot and improve systems and processes. Review corrective actions and implementation closure evidence of observations/recommendations identified in the report.
  • Support internal, client, and regulatory audits and inspections.
  • Generate or review/update computer system related policies, procedures, templates, forms, etc.
  • Maintain up-to-date knowledge and understanding of quality system requirements as they apply to computerized system in accordance with cGxP’s regulations, GAMP, industry standards, policies and procedures.
  • Performs other quality system related duties as necessary.
REQUIREMENTS
  • BA/BS Degree in a Scientific or Engineering discipline
  • 8 + years experience computerized system experience with IT compliance/validation/qualification activities.
  • 8 + years experience working in an FDA-regulated, GxP-related environment.
  • Demonstrated experience and expertise in 21 CFR Part 11 to ensuring site compliance.
  • Comprehensive knowledge in Software Validation and Data Integrity Principles.
  • Demonstrated experience, results, and accomplishments in QMS and LIMS system implementations.
  • Working knowledge or expertise in Software validation practices and Software Development Life Cycle (SDLC) models.
  • Working knowledge or expertise in Validations of Databases, Custom Software, Configurable Software, Non-Configurable Software, Infrastructure Software, Off-the-shelf software and various computerized systems.
  • Working knowledge or expertise in Design Qualifications (DQ), Installation Qualifications (IQ), Operational Qualifications (OQ), and Performance Qualifications (PQ).
  • Knowledge of Software Risk Management Principles and tools.
  • Knowledge and proven ability working with Risk Management methodologies and tools.
  • Comprehensive knowledge of GAMP5, 21 CFR Part 11, and EU Annex 11 as well as FDA 21 CFR Parts 210/211 (cGMP), ICH Q10, Eudralex Vol 4. Knowledge of PMDA regulations a plus.
  • Experience with application system validation and infrastructure qualification.
  • Experience with vendor audit for computer systems (IT infrastructure, validation etc.) a plus.
  • Experience with writing and approving Standard Operating Procedures and Quality Standards.
  • Proficient in Microsoft Office Suite (e.g., Word, Excel, Project, PowerPoint).
  • Must have a participative management style, strong team development, coaching skills, and the ability to lead and motivate teams.
  • Excellent verbal and written communication skills with the ability to communicate internally and externally to clients and suppliers.
  • Solid organizational and time management skills, proven project management, presentation and facilitation skills.
  • Innovation and strategic compliance skills including looking internally and externally for best practices.
  • The ability to effectively build and maintain relationships with multiple departments in order to effectively solve problems.
  • The ability to organize, prioritize and deliver tasks & projects with a sense of urgency under minimal supervision with attention to detail. Must be able to execute a variable workload with multiple priorities.
  • The ability to enable and drive change while being focused on internal and external customers.
  • Demonstrated results oriented, quick learner, team player; proactive with demonstrated ability to respond to urgent needs and deliver expected results within expected deadlines.
  • Environment includes working with all levels of internal management and staff as well as with external clients, suppliers, and contractors. Work will be performed in both an office environment and a manufacturing facility, with exposure to varying degrees of ambient noise.
  • 10% travel required.
Please note this job description is not designed to cover or contain a comprehensive listing of activities, duties, or responsibilities that are required of the employee for this job. Duties, responsibilities, and activities may change at any time with or without notice.