At Johnson & Johnsonwe believe health is everything. Our strength in healthcare innovation empowers us to build aworld where complex diseases are prevented treated and curedwhere treatments are smarter and less invasive andsolutions are our expertise in Innovative Medicine and MedTech we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow and profoundly impact health for more at
Job Function:
QualityJob Sub Function:
Quality SystemsJob Category:
People LeaderAll Job Posting Locations:
Malvern Pennsylvania United States of America Milpitas California United States of America Raritan New Jersey United States of America Spring House Pennsylvania United States of America Tampa Florida United States of America Titusville New Jersey United States of AmericaJob Description:
We are seeking a QCS Engineering Manager located at one of the following sites: Skillman Raritan NJ Titusville NJ Malvern PA Springhouse PA Milpitas CA or Tampa FL.
The Quality Compliance and Sustainability (QCS) Engineering Manager for Laboratory Systems will lead the maintenance enhancement and implementation of current and future solutions supporting various laboratory processes. This is a hands-on leadership role requiring technical expertise strong management skills and adherence to High Performance Team (HPT) standards. The position involves coordinating with business partners securing resources and managing consultant teams to deliver validated solutions in a GxP-compliant environment.
Major Responsibilities:
Lead QCS lab development projects ensuring performance meets SLAs and delivery timelines
Develop and implement innovative solutions aligned with approved standards (SDLC Agile Waterfall)
Configure lab systems (e.g. Empower DACs AQF packages) manage IQ/OQ testing upgrades deployments and data migrations
Drive system integrations and collaboration across IT and business teams
System & Process Improvement:
Capture customer insights and recommend continuous improvements
Conduct fit-for-use analyses on vendor tools; manage licenses and influence vendor roadmaps
Provide knowledge transfer to internal teams post delivery
Project Planning & Resource Management
Coordinate resource needs with business partners; create and manage SOWs
Identify onboard and manage consulting teams; monitor milestones and reconcile invoicing
Maintain clear communication on project progress risks and mitigation plans
Additional Duties
Analyze incoming demand and assess technical solutions
Act as technical lead for QS platform design and configuration
Ensure compliance with J&J standards and regulatory requirements
Drive continuous improvement and resolve technical challenges to deliver business benefits.
Requirements:
BA/BS degree required
Minimum 2 years of experience translating business requirements into technical solutions
Minimum of 2 years of experience working with Laboratory Information Management Systems (LIMS) such as LabVantage and/or LabWare.
Minimum 3 years of hands-on experience with laboratory systems including:
Chromatography Data System (CDS) preferably Waters Empower
Scientific Data Management System (SDMS) preferably Waters NuGenesi
Compliance Builder (CB) preferably Instem/Xybion
Experience with relational databases and scripting for data migrations required.
Proven ability to identify onboard train and manage consulting teams to deliver projects on time and within budget is required.
Experience collaborating with business partners to align project funding and create Statements of Work (SOWs) for resource acquisition required.
Strong knowledge of SDLC methodology 21 CFR Part 11 GxP CSV frameworks and validated system highly preferred.
Johnson & Johnson is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race color religion sex sexual orientation gender identity age national origin disability protected veteran status or other characteristics protected by federal state or local law. We actively seek qualified candidates who are protected veterans and individuals with disabilities as defined under VEVRAA and Section 503 of the Rehabilitation Act.
Johnson & Johnson is committed to providing an interview process that is inclusive of our applicants needs. If you are an individual with a disability and would like to request an accommodation external applicants please contact us via internal employees contact AskGS to be directed to your accommodation resource.
#JNJTech
Required Skills:
Laboratory Information Management System (LIMS) Relational Database Technical SolutionsPreferred Skills:
Collaborating Compliance Management Corrective and Preventive Action (CAPA) Data Quality Data Savvy Developing Others Incident Management Inclusive Leadership Leadership Operations Management Performance Measurement Quality Control (QC) Quality Management Systems (QMS) Quality Services Quality Standards Risk Management System Integration Systems Analysis Tactical Planning Team ManagementThe anticipated base pay range for this position is :
$102000.00 - $177100.00For Bay Area:
$118000.00 - $203550.00Additional Description for Pay Transparency:
Subject to the terms of their respective plans employees are eligible to participate in the Companys consolidated retirement plan (pension) and savings plan (401(k)).Required Experience:
Manager
About Johnson & Johnson A t Johnson & Johnson, we believe good health is the foundation of vibrant lives, thriving communities and forward progress. That’s why for more than 130 years, we have aimed to keep people well at every age and every stage of life. Today, as the world’s larges ... View more