1 - 20 of 52 Jobs

Validation Engineer, Trackwise

I.T. Solutions

Seattle, Washington, USA

Contract

Role: Sr. CSV Engineer, Trackwise Location: Seattle Washington Type: Contract Length: 1 year at least As a Computer Systems Validation (CSV) Consultant you will: Apply your professional knowledge of 21CFR Part 11 systems validation and regulatory compliance with a range of computerized systems in pharmaceutical and biotech Manufacuring and other GxP and GAMP regulated environmentsPerform as a project execution and thought leader to provide regulatory guidance regarding compliance with intended

Validation Engineer / Specialist

Advantage Technical

Birmingham, Alabama, USA

Full-time

Validation Engineer / Specialist Position Type: Contract Position Location: Birmingham, AL Position Salary: $65/HR - $75/HR (Depending on Experience) Responsibilities: Support and execute all phases of assigned projects from concept through implementation. Follow GMP regulatory compliance, adherence to the site Qualification & Validation Master Plan (QVMP), Standard Operating Procedures (SOP's) and Business Line Policies/Procedures. Work on multi-faceted projects (Capital, Client and Overhead),

CSV Lead

VDart, Inc.

Raritan, New Jersey, USA

Contract, Third Party

Job Title: CSV Lead Location: Raritan, NJ Onsite Duration/Term: 6+ months Contract Job Description: Validating ERP to AWS Data migration process and Validating Data migration project Experience in the Pharmaceutical, biotechnology, or medical device industry 5+ years' experience with System Development Lifecyle 5+ years' experience in Computer System Validation (Based on the role selected) Experience in FDA and/or Global regulated environment with good understanding of GxP standards and Risk

Validation Specialist with (Clinical Development, Drug Discovery, MES, QMS, LIMS)

W3Global

Raritan, New Jersey, USA

Third Party, Contract

Job Details: 10+ years' experience in Computer System Validation or Quality management or Business Analysis in GxP application area Has working experience in any one or two of the following domains - Clinical Development and Supply Chain, Drug Discovery, MES, QMS, LIMS, Data Integrity Platforms Guide the project team with the right set of applicable project deliverables based on project type and category while catering to the SDLC Application of FDA guidance's and industry standards (i.e., GAMP)

Validation Engineer

Evoke Technologies

Summit, New Jersey, USA

Contract

Job Title: Validation Engineer Job Location: Summit West, NJ (need local candidates only) Job Duration: 6 months Employment Type: w2 hourly REQUIRED COMPETENCIES: Knowledge, Skills, and Abilities: Knowledge of cGMP, GXP, GAMP, and SDLC regulations, including 21CFR part 11, computer systems validation requirements, and good documentation practices.Experience in the qualification of cell therapy equipment is a plusAdvanced knowledge of pharmaceutical, manufacturing, and laboratory systems.Underst

validation Engineer

Advantage Technical

Waltham, Massachusetts, USA

Full-time

Validation Engineer Terrific hybrid opportunity to join a growing local pharmaceutical company. We are seeking a Program Manager to join our dynamic team in Waltham, MA. Come and build a satisfying career with our world class staff. We offer a competitive salary, annual bonuses, and a comprehensive benefits package. Apply now, we would love to work with you! Must work onsite in Waltham 3 days per week. Local candidates. Will be supporting computer system/computerized equipment validation activi

QMS Software Validation Engineer

Philips North America

Cambridge, Massachusetts, USA

Full-time

Job Title QMS Software Validation Engineer Job Description Looking at the challenges the world is facing today Philips' purpose has never been more relevant. So, whatever your role, if you share our passion for helping others, you'll be working towards creating a better and fairer future for all. In this role you have the opportunity to Support project teams by providing awareness, guidance and feedback on validation deliverables and test execution per Philips SDLM policies and procedures. Yo

Manager, Software Quality Engineer

Fresenius Medical Care

Lawrence, Massachusetts, USA

Full-time

PURPOSE AND SCOPE: The Manager, Software Quality Engineering is responsible for ensuring all GxP Computer Systems follow Corporate CSV policies and procedures. This role will have both managerial and operational responsibilities in the deployment and enforcement of FMC RTG Software Quality policies, procedures and templates. The position will lead a small team of validation engineers to manage, establish, implement and organize Software Quality activities for identified Computer systems. This p

Quality Assurance Engineer II

Danaher Corporation

Miami, Florida, USA

Full-time

Wondering what's within Beckman Coulter? Take a closer look. Join a team where you can be heard, be supported, and always be yourself. At Beckman Coulter, a Danaher company, we're building a culture that celebrates culture, experiences, and perspectives of all our associates. At first glance, you'll see we are dedicated to advancing and optimizing the laboratory to move science and health care forward for more than 80 years. Look again and you'll see we are invested in you and you'll have the op

Senior Automation Engineer

Regeneron Pharmaceutical

East Greenbush, New York, USA

Full-time

Our Automation Engineers keep our cutting-edge process controls and process monitoring systems running at peak efficiency. We provide unsurpassed expertise in designing, developing, implementing, and optimizing Regeneron's sophisticated biopharmaceutical manufacturing processes. As an Automation Engineer, a typical day might include the following: Designing, developing, and implementing software/hardware improvements to existing automated equipment and new equipment according to change control

MES Consulting Engineer

Zachary Piper Solutions, LLC

Cary, North Carolina, USA

Full-time

Do you have a passion for optimizing manufacturing processes in the pharmaceutical industry? Are you an expert in PAS-X systems? If so, we want to hear from you! We are seeking a highly motivated MES Engineer to join our team and play a key role in the design and implementation of a PAS-X system for our state-of-the-art drug product and finished goods facility. Responsibilities: Collaborate with internal stakeholders to define MES requirements and develop User Requirement Specifications (URS)

Validation Engineer day shift Columbus Plant

Abbott Laboratories

Columbus, Ohio, USA

Full-time

Abbott is a global healthcare leader that helps people live more fully at all stages of life. Our portfolio of life-changing technologies spans the spectrum of healthcare, with leading businesses and products in diagnostics, medical devices, nutritionals and branded generic medicines. Our 114,000 colleagues serve people in more than 160 countries. Nourish the world and your career as part of the Nutrition team at Abbott. Abbott's Nutrition Division develops science-based nutrition products for p

Automation Engineer

Regeneron Pharmaceutical

East Greenbush, New York, USA

Full-time

Our Automation Engineers keep our cutting-edge process controls and process monitoring systems running at peak efficiency. We provide unsurpassed expertise in designing, developing, implementing, and optimizing Regeneron's sophisticated biopharmaceutical manufacturing processes. As an Automation Engineer, a typical day might include the following: Designing, developing, and implementing software/hardware improvements to existing automated equipment and new equipment according to change control

Principal/Sr. Principal Engineer, Process

Boehringer Ingelheim Pharmaceuticals

Athens, Georgia, USA

Full-time

Description As an employee of Boehringer Ingelheim, you will actively contribute to the discovery, development, and delivery of our products to our patients and customers. Our global presence provides opportunity for all employees to collaborate internationally, offering visibility and opportunity to directly contribute to the companies' success. We realize that our strength and competitive advantage lie with our people. We support our employees in several ways to foster a healthy working enviro

Senior Manufacturing Engineer (Vision)

Abbott Laboratories

Buffalo Grove, Illinois, USA

Full-time

Abbott is a global healthcare leader that helps people live more fully at all stages of life. Our portfolio of life-changing technologies spans the spectrum of healthcare, with leading businesses and products in diagnostics, medical devices, nutritionals and branded generic medicines. Our 114,000 colleagues serve people in more than 160 countries. Working at Abbott At Abbott, you can do work that matters, grow, and learn, care for yourself and family, be your true self and live a full life. Yo

Information Technology/Operational Technology (IT/OT) Specialist

Novartis

Indianapolis, Indiana, USA

Full-time

About the Role Location: On-site At Advanced Accelerator Applications, a Novartis company, we are committed to leading innovation in nuclear medicine and delivering the next generation of targeted radioligand therapy (RLT) to cancer patients. As an IT OT Specialist, you will play a crucial role in supporting our 24/7 plant operations and maintaining the integrity of our IT services. Responsibilities: Provide technical support and assistance in the integration of our IT and OT (Operational Techn

Manager, Computerized Systems

Civica Rx

Petersburg, Virginia, USA

Full-time

AboutCivica Civica is a 501(c)(4) social welfare organization established in 2018 by health systems and philanthropies to reduce chronic generic drug shortages and related high prices in the United States. Civica is led by an experienced team of healthcare and pharmaceutical industry leaders. Today, more than 55 health systems have joined Civica. They represent over 1,500 hospitals and one-third of all U.S. hospital beds. Civica has also begun to supply the U.S. Department of Veterans Affairs,

System Sales Engineer

Parker Hannifin

Oxnard, California, USA

Full-time

Position Summary Parker Hannifin Corporation's Bioscience & Water Filtration Division focuses on the intersection of biological sciences and filtration technologies to address critical challenges in manufacturing processes. We bring decades of experience in the Food & Beverage, Microelectronics, Industrial & Chemical, and Biopharmaceutical industries where purity is a key component in our customer's final products. Within our unique platform, we partner with Biopharmaceutical industry leaders to

Principal Delta V Automation Engineer

Danaher Corporation

Marlborough, Massachusetts, USA

Full-time

Be part of something altogether life-changing! Working at Cytiva means being at the forefront of providing new solutions to transform human health. Our incredible customers undertake life-saving activities ranging from fundamental biological research to developing innovative vaccines, new medicines, and cell and gene therapies. At Cytiva you will be able to continuously improve yourself and us - working on challenges that truly matter with people that care for each other, our customers, and the

Manager of Instrumentation and Calibration

AstraZeneca

Rockville, Maryland, USA

Full-time

Join us as a Manager of Instrumentation and Calibration, where you will oversee departmental activities regarding the planning and scheduling of all routine and non-routine events and any related areas of responsibility to maintain a GMP facility. This is your chance to break new ground and leave a collective legacy in our Operations team! What you will do:Business Process Owner for Instrumentation and Calibration activities.Drive continuous improvement across processes and procedures.Develop a