81 - 100 of 134 Jobs

Commissioning & Qualification (C&Q) Engineer

Katalyst Healthcares and Lifesciences

Harrisburg, Pennsylvania, USA

Full-time

Responsibilities: Develop and execute commissioning protocols (FAT, SAT, IQ, OQ and PQ) for equipment, systems, and facilities. Perform system startup, debugging, and initial testing of process and utility systems. Ensure that systems are installed and operating according to design specifications. Collaborate with engineering, manufacturing, and quality teams during equipment installation and commissioning. Review and verify system documentation, such as P&IDs, wiring diagrams, and datashee

Validation Engineer 4

Katalyst Healthcares and Lifesciences

Littleton, Colorado, USA

Full-time

Job Description: We are seeking a detail-oriented and experienced LabVantage Business Analyst to support the implementation, optimization, and ongoing support of LabVantage LIMS (Laboratory Information Management System). The ideal candidate will work closely with business stakeholders, scientists, QA teams, and IT to gather requirements, analyze workflows, and ensure that LabVantage solutions align with organizational needs. Responsibilities: ct as the liaison between scientific/business teams

Validation Engineer

Katalyst Healthcares and Lifesciences

Fall River, Massachusetts, USA

Full-time

Job Description: The Validation Engineer is responsible for developing DQ/IQ/OQ/PQ protocols and coordinating and performing equipment qualifications, ensuring that automated process equipment that mass produce medical device consumables and other products, are designed, developed or changed in compliance with specifications, requirements, safety and Company and regulatory guidelines. The Validation Engineer will work closely with Senior validation staff, maintenance, operations, and R&D teams t

Sr. Equipment Engineer - 2nd Shift

Johnson & Johnson

Danvers, Massachusetts, USA

Full-time

At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through 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 humanity. Learn m

Computer System Validation Analyst - R Studio & Clinical Systems

Katalyst Healthcares and Lifesciences

Remote or New Jersey, USA

Full-time

Responsibilities: Lead validation planning, risk assessment, and execution for R Studio, GitLab, and Medidata Rave EDC. Develop and execute validation documentation including: Validation Plans (VP.). User Requirements Specifications (URS.). Risk Assessments (RA.). Functional and Design Specifications. Traceability Matrix (RTM.). Test Protocols (IQ/OQ/PQ or CSA-based scripts.). Validation Summary Reports (VSR.). Collaborate with cross-functional stakeholders including Clinical Data Mana

SAP PP/PM Functional Consultant (Manufacturing & Maintenance)

LGL Technologies

Saint Paul, Minnesota, USA

Contract

Senior SAP PP/PM Functional Consultant (Manufacturing & Maintenance) St. Paul, MN 55144- Hybrid Job Summary: Seeking a highly experienced SAP PP/PM implementation specialist with deep domain expertise in pharmaceutical manufacturing and equipment maintenance. The consultant will lead comprehensive manufacturing implementations, bringing extensive knowledge of production planning, quality integration, and maintenance strategies in validated environments. Key Responsibilities: SAP Implementation

LIMS Master Data Specialist

Katalyst Healthcares and Lifesciences

Summit, New Jersey, USA

Full-time

Position Summary: Responsible for the creation and execution of computer system validation document as well as providing operational support and guidance related to system use and improvement. Responsibilities: Create and execute computer system validation documents (i.e., UAT, URS, OQ, PQ, etc.) as applicable and guide QC end users on the development of system enhancements with user requirements and business drivers. Provide electronic systems operational support and troubleshooting to end use

Area Engineer - CUB & Tank Farm Lilly Medicine Foundry

Eli Lilly and Company

Indianapolis, Indiana, USA

Full-time

At Lilly, we unite caring with discovery to make life better for people around the world. We are a global healthcare leader headquartered in Indianapolis, Indiana. Our employees around the world work to discover and bring life-changing medicines to those who need them, improve the understanding and management of disease, and give back to our communities through philanthropy and volunteerism. We give our best effort to our work, and we put people first. We're looking for people who are determined

Process Engineer

Eli Lilly and Company

Indianapolis, Indiana, USA

Full-time

At Lilly, we unite caring with discovery to make life better for people around the world. We are a global healthcare leader headquartered in Indianapolis, Indiana. Our employees around the world work to discover and bring life-changing medicines to those who need them, improve the understanding and management of disease, and give back to our communities through philanthropy and volunteerism. We give our best effort to our work, and we put people first. We're looking for people who are determined

Sr. Analyst, IT Validation Services

Russell, Tobin & Associates

Remote or Stamford, Connecticut, USA

Contract

Job Title: Sr. Analyst, IT Validation Services Location: Remote Duration: 12 Months Pay Range: $30/hr-$35/hr on W2 (DOE) Primary Responsibilities Creation, review, approval, and DMS processing of Computer System Lifecycle deliverables for Projects and Change Controls: Validation Plans/Summary Reports Risk Assessments User Requirements Specifications Test Plans Test Scripts: IQ, OQ or PQ Assess and implement the most effective validation strategy for each activity. Oversee test execution for c

Verification and Validation R&D Engineer

Katalyst Healthcares and Lifesciences

Marlborough, Massachusetts, USA

Full-time

Responsibilities: Designs, develops, and implements cost-effective methods of testing and troubleshooting systems and equipment. Prepares test and diagnostic plans/programs and infrastructure, designs test fixtures and equipment, and completes specifications and procedures for new products. Plans the labor, schedules, and equipment required for testing and evaluating standard and special devices. Lead and execute Verification and Validation (V&V) activities for disposable kit development. De

Equipment Validation Engineer

Apex Systems

Indianapolis, Indiana, USA

Full-time

Job#: 2073087 Job Description: Role: Equipment Validation Engineer Location: Indianapolis, IN (On-Site) Type: Long Term Contract Apex Systems, a global leader in Technology Services, is searching for an Equipment Validation Engineer in Indianapolis, IN for a large Life Sciences client. This is a long term contract with an immediate start date. This role requires on site support 5 days a week due to the nature of the role. See below for more details! Duties and Responsibilities: Supports the

Automation Engineer

Novartis

Indianapolis, Indiana, USA

Full-time

Job Description Summary Responsible for maintaining, troubleshooting, and supporting all automation equipment and control systems to ensure the smooth and reliable operation of the new Isotope building. This role will oversee the installation, commissioning, and ongoing optimization of automated processes and equipment, ensuring compliance with safety, regulatory, and quality standards. The position requires providing 24/7 technical support once the plant is operational, promptly addressing any

Sourcing Engineer - Supply Chain

HealthTrust

Nashville, Tennessee, USA

Full-time

Description Introduction Experience the HCA Healthcare difference where colleagues are trusted, valued members of our healthcare team. Grow your career with an organization committed to delivering respectful, compassionate care, and where the unique and intrinsic worth of each individual is recognized. Submit your application for our Sourcing Engineer opening with HealthTrust today and find out what it truly means to be a part of the HCA Healthcare team. The Sourcing Engineer plays a crucial r

Senior Process Engineer - VA

Novo Nordisk Inc

Petersburg, Virginia, USA

Full-time

About the Department For more than 100 years, Novo Nordisk has been tackling the unmet medical needs of people living with serious chronic diseases, such as diabetes & obesity. Being part of Novo Nordisk allows our employees to embark on life-changing careers, and the opportunity to help improve the quality of life for millions of people around the world. Our new Petersburg, Virginia site marks a strategic move to advance our capabilities in Emerging Technologies (ET) within Chemical API devel

Validation Engineer

Katalyst Healthcares and Lifesciences

Warsaw, Indiana, USA

Full-time

Responsibilities: Develops and Executes Cleaning Validation Strategies: Creates plans, protocols (IQ, OQ, PQ), and risk assessments to ensure effective cleaning processes for medical devices and equipment. Ensures Regulatory Compliance: Adheres to FDA (21 CFR 820), ISO 13485, and other relevant regulations, participating in audits and maintaining up-to-date knowledge. Analyzes Data and Reports Findings: Compiles and analyzes validation data, writes comprehensive reports, and identifies trends

Principal Validation Engineer

Johnson & Johnson

Danvers, Massachusetts, USA

Full-time

At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through 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 humanity. Learn m

Equipment and Automation Controls Engineer

Katalyst Healthcares and Lifesciences

Atlanta, Georgia, USA

Full-time

Job Description: We are seeking a highly skilled Equipment and Automation Controls Engineer to join our team. This role involves designing, implementing, installing, analyzing and/or optimizing manufacturing processes, procedures, equipment, and programming. The ideal candidate will also have expertise in PLC and automation controls, ensuring seamless integration and functionality of mechatronic systems to best support our 24/7 operation. Responsibilities: Manufacturing Process Improvements: Le

C&Q Engineer - (Commissioning & Qualification) || Harrisburg, PA (Onsite)

Stellent IT LLC

Harrisburg, Pennsylvania, USA

Contract, Third Party

Position: C&Q Engineer Location: Harrisburg, PA (Onsite) Duration: 12+ month contract Multiple Openings - Standard C&Q profile ideally with 7+ years' experience. More experience the better Job Description :- We are looking for a highly skilled Senior Commissioning & Qualification (C&Q) Engineer to support our Life Sciences projects. The ideal candidate will have extensive experience in qualification and validation activities, ensuring compliance with industry regulations and best practices.

Supplier Engineer II

Johnson & Johnson

Remote or Danvers, Massachusetts, USA

Full-time

At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through 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 humanity. Learn m