1 - 20 of 373 Jobs

Reliability Engineer

Cushman & Wakefield

Boston, Massachusetts, USA

Full-time

Job Title Reliability Engineer Job Description Summary As a key member of the Reliability Engineering team, the lead Reliability Engineering will provide strategic and hands-on support for GxP Facility Operations and Engineering across Vertex GxP sites. This role will drive the implementation of maintenance and reliability best practices, focusing on maximizing equipment and system performance while ensuring compliance with GxP and Good Engineering Practices (GEP). The ideal candidate will lead

Validation Support Engineer

Katalyst Healthcares and Lifesciences

Boston, Massachusetts, USA

Full-time

Job Description: We are seeking an experienced Validation Support Engineer to lead validation activities for Beckhoff Twin CAT PLC-controlled systems in a 24/7 GMP-regulated manufacturing environment. The role focuses on ensuring compliance with FDA regulations (21 CFR Part 11, 210, 211, 820), GAMP5 methodologies, and internal quality standards. Responsibilities: Develop/update Validation Plans (VP) and Master Validation Plans (MVP). Lead GxP risk assessments for system changes. Author and

Sr. Validation Engineer (CSV)

Katalyst Healthcares and Lifesciences

California, USA

Full-time

Responsibilities: Create and execute Computer System Validation (CSV) deliverables (Validation Plans, Protocols, Reports, Trace Matrices, SOPs). Collaborate with Business Users, System Owners, IT teams, and Analysts to define validation requirements. Provide leadership and training in validation activities. Generate IQ/OQ/PQ protocols using Good Documentation Practices (GDP). Ensure compliance with quality system elements for computer systems/software testing. Perform gap assessments and remedia

Engineer - Syncade or PharmaSuite MES System

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

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

SAP Integration Lead

Judge Group, Inc.

Boston, Massachusetts, USA

Contract

Location: Boston, MA Salary: $75.00 USD Hourly - $80.00 USD Hourly Description: Job Title: SAP Integration Lead Location: Boston, MA (Hybrid) Duration: 6+ months Contract Need Locals Only Required Qualifications: Bachelor's degree in Computer Science, Engineering, Life Sciences, or a related field8+ years of SAP integration experience, with 3+ years in a regulated pharmaceutical environmentExpertise in SAP CPI, PI/PO, IDoc/ALE, RFC, BAPI, and API-based integrationStrong understanding of SAP

Sr Engineer - Software

ACL Digital

Thousand Oaks, California, USA

Full-time

Exact Schedule - fully onsite thousand oaks 8am-5pm M-F, OT possible Job Responsibilities include: 1) Developing process control applications utilizing Programmable Logic Controllers (PLC), Distributed Control Systems (DCS), Human Machine Interfaces (HMI) and Supervisory Control and Data Acquisition systems (SCADA). 2) Support projects focused on improving process equipment/utilities/facilities -to- sophisticated unit operation skids to integrate new drug product manufacturing technologies into

EMS Validation Engineering Lead

Schneider Electric

Horsham, Pennsylvania, USA

Full-time

For this U.S. based position, the expected compensation range is $96,000 - $144,000 per year, which includes base pay and short-term incentive. The compensation range for this full-time position applies to candidates located within the United States. Our salary ranges are determined by reviewing roles of similar responsibility and level. Within the salary range, individual pay is determined by several factors including performance, knowledge, job-related skills, experience, and relevant educatio

Automation Engineer

Katalyst Healthcares and Lifesciences

Thousand Oaks, California, USA

Full-time

Responsibilities: Manage day-to-day support of ATO Drug substance operations. Represent plant automation team in Area WCTs. Lead a team of Automation engineers responsible to support and deliver on complex capital construction projects including Global Lifecycle Asset Management (GLAM) projects. Lead the direct reports including External Workers (EWs), onboarding the EWs, and ensuring the direct reports' adherence to Client training requirements. Represent Plant Automation team during the develo

Engineer - MES System

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

Computer System Validation

Smart Source Technologies

Jacksonville, Florida, USA

Contract

Computer System Validation Jacksonville, FL Onsite 12 months contract Pay : $55/hr W2 or $60/hr C2C Job Description:- Working knowledge of FDA and European medical device regulations (QSR and ISO) is required. Working knowledge of software validation requirements for software used in the production of medical devices and software used to support the Quality System is required. Working knowledge of GAMP5 and SDLC is required. Working knowledge of regulations for electronic records, electronic

Computer System Validation Lead

Nityo Infotech Corporation

Remote

Contract, Third Party

Job Details: 7-10 years experience in Computer System Validation of EMS and BMS applications Must have experience in Agile methodology and handled multiple releases in parallel Extensive knowledge in CSV, CSV auditing, creation and revision of CSV documentation, experience with EMS/BMS, project management, test script review, test execution review, test defect management. Has working experience in any one or two of the following domains Tool validation like ServiceNOW, Automation tools, JIRA Gu

Manager-Strategic Sourcing and Supplier Management

NexInfo Solutions, Inc.

Foster City, California, USA

Contract, Third Party

About Nexinfo; NexInfo is a consulting firm focused on improving business processes and automation in the Supply Chain and Product Lifecycle Management sectors. They offer services in business process design, software implementations, managed services, staff augmentation, and SaaS solutions. The company aims to help businesses across industries achieve their goals through industry best practices, lean process design, and advanced software solutions. Their ERP-related services address challenges

Sr DeltaV Automation Engineer

Intone Networks Inc.

Michigan, USA

Full-time, Third Party, Contract

Sr DeltaV Automation Engineer - Muskegon, MI - onsite Job Summary: This is an onsite role to help with commissioning efforts of a DeltaV system and mentor other Junior and Intermediate Engineers. The client and the project team have been working very well together with high collaboration, communication, adaptability, and a good sense of camaraderie making the work environment enjoyable and engaging. We're looking someone who is strong technically but also a great team player, collaborative, an

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

Stellent IT LLC

Harrisburg, Pennsylvania, USA

Third Party, Contract

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.

Digital Data Systems and Applications Sr. Manager, Engineering

Novartis

Hanover

Full-time

Job Description Summary This position will be located at East Hanover, NJ site and will not have the ability to be located remotely. "Please note that this role would not provide relocation and only local candidates will be considered." Novartis is a world-leading healthcare company that provides solutions to address the evolving needs of patients worldwide. Our TRD Cell & Gene Therapies Engineering department is looking for an experienced Digital Data IT/OT Systems and Applications Sr. Manager

FSQA - Food Safety and Quality Assurance Manager

Agile Global Solutions, Inc

Linden, New Jersey, USA

Full-time

Position Overview: The FSQA Leader will play a key role in advancing the facilitys food safety and quality programs, ensuring alignment with regulatory standards (FDA, USDA, HACCP, FSMA), customer expectations, and internal best practices. This position offers an exciting opportunity to contribute to a dynamic, forward-thinking culture focused on quality, innovation, and operational excellence. Key Responsibilities: Lead, enhance, and support food safety and quality assurance programs, including

FSQA - Food Safety and Quality Assurance Manager

Agile Global Solutions, Inc

Indianapolis, Indiana, USA

Full-time

Description: FreshRealm is currently in a high-growth state, and our culture of ACTIONS drives our team members forward to maximize their potential. We are a team of hardworking, passionate leaders who persevere through challenges, collaborate with one another to problem solve and achieve desired outcomes, and work to bring out the best in our employees as we service our customers. At FreshRealm, we welcome individuals from all backgrounds and abilities to apply and make employment decisions bas

Manufacturing Technician (2nd shift)

Cube Hub, Inc.

Redwood City, California, USA

Contract

Job Title : Manufacturing Technician Location : Redwood City, CA, 94063 Duration : 12 months Contract-possible to extend Shift Details : 2nd shift-1:30 Pm to 10PM Pay Range : $23/hr. - $25/hr. Job Description: Typical Accountabilities o Conduct activities and interactions consistent with Company values and in compliance with the Code of Conduct and supporting Policies and Standards relevant to your role. Complete all required training on the Code of Conduct and supporting Policies and Stand

Senior Electrical Engineer

Aditi Consulting

New Albany, Ohio, USA

Contract

Payrate: $50.00 - $54.00/hr. Summary: The Engineer position reports to the Manager of Engineering under the Engineering & Maintenance team at the facility. This position requires the application of diverse and advanced engineering and scientific principles in support of commercial GMP Final Drug Product (FDP) operations in the manufacturing facility. The site of the new advanced product assembly and packaging plant, this role will apply advanced and diverse engineering principles to the design a