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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
Posted 60+ days ago | Updated 7 hours ago

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
Posted 60+ days ago | Updated 7 hours ago

IDAP MES System Engineer Tech@Lilly

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
Posted 1 day ago | Updated 7 hours ago

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
Posted 33 days ago | Updated 4 hours ago

Computer System Validation Engineer

Katalyst Healthcares and Lifesciences

•

Libertyville, Illinois, USA

Full-time

Responsibilities: The Manufacturing IT Systems Quality & Compliance Specialist- Cell Therapy Manufacturing Systems supports the successful operation of manufacturing and business functions at Libertyville site through interaction with internal team members, peer and higher-level customers as well as external service providers. The individual is responsible for the development of and adherence to system governance procedures. The individual supports multiple IT projects/systems and ongoing work a
Posted 60+ days ago | Updated 7 hours ago

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
Posted 44 days ago | Updated 7 hours ago

CSV Engineer

Katalyst Healthcares and Lifesciences

•

New Brunswick, New Jersey, USA

Full-time

Job description: We're seeking a Senior MES Engineer/Validation Lead to take ownership of computer system validation activities for Manufacturing Execution Systems (MES) supporting cell therapy manufacturing. This role is ideal for someone with a strong IT/Computer Science foundation and 3 years of hands-on experience in the pharma/biotech industry. You'll partner with QA, Business, and IT teams to ensure compliant and efficient deployment of MES & Recipes solutions. Responsibilities: Lead end
Posted 60+ days ago | Updated 7 hours ago

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
Posted 60+ days ago | Updated 7 hours ago

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
Posted 20 days ago | Updated 7 hours ago

Director Quality Systems

Medline Industries, LP

•

Mundelein, Illinois, USA

Full-time

Job Summary Job Description The Director of Manufacturing Quality Systems is responsible for the strategy, delivery and ongoing support across the manufacturing quality systems. This role will be responsible for collaborating closely with the Quality organization as well as the plant GMs to ensure Quality Systems roadmap is closely aligned to support the strategic business initiatives, objectives and goals. In addition, the leader will be responsible for working closely with various stakehold
Posted 47 days ago | Updated 4 hours ago

CSV Engineer

Katalyst Healthcares and Lifesciences

•

Jacksonville, Florida, USA

Full-time

Responsibilities: Lead computer software validation (CSV) project planning activities including the creation or updates to URS, SDS and RTM documents. Create, review and approve software validation documentation. Create and execute qualification protocols and document reports; review and approve software test scripts and code reviews. Review and approve internal and vendor software packages and test documentation. Prioritize and plan all assigned projects for the software validation department.
Posted 60+ days ago | Updated 7 hours ago

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
Posted 34 days ago | Updated 7 hours ago

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.
Easy Apply
Posted 60+ days ago | Updated moments ago

Senior Full Stack Software Engineer - Quality Issue and Incident Management

General Motors

•

Austin, Texas, USA

Full-time

Job Description Workplace Classification: Hybrid : This role is categorized as hybrid. This means the candidate is expected to report to their primary work location (Austin, TX or Warren, MI) three times per week, at minimum, or other frequency dictated by the business The Team: The Quality Issue & Incident Management group is a persistent team that supports the Global Quality business organization. The team is compromised of developers and Business Analysts that support GIMS, Partlink, QPS, an
Posted 4 days ago | Updated 4 hours ago

Senior Software Developer

General Motors

•

Austin, Texas, USA

Full-time

Job Description Sponsorship: GM DOES NOT PROVIDE IMMIGRATION-RELATED SPONSORSHIP FOR THIS ROLE. DO NOT APPLY FOR THIS ROLE IF YOU WILL NEED GM IMMIGRATION SPONSORSHIP NOW OR IN THE FUTURE. THIS INCLUDES DIRECT COMPANY SPONSORSHIP, ENTRY OF GM AS THE IMMIGRATION EMPLOYER OF RECORD ON A GOVERNMENT FORM, AND ANY WORK AUTHORIZATION REQUIRING A WRITTEN SUBMISSION OR OTHER IMMIGRATION SUPPORT FROM THE COMPANY (e.g., H-1B, OPT, STEM OPT, CPT, TN, J-1, etc.) Hybrid: This position allows flexibility ut
Posted 58 days ago | Updated 4 hours ago

Senior Automation Engineer

Takeda pharmaceutical

•

Lexington, Massachusetts, USA

Full-time

By clicking the "Apply" button, I understand that my employment application process with Takeda will commence and that the information I provide in my application will be processed in line with Takeda's Privacy Notice and Terms of Use. I further attest that all information I submit in my employment application is true to the best of my knowledge. Job Description About the Role: As a Senior Automation Engineer, you will work in a hybrid position and be part of the Automation engineering group
Posted 26 days ago | Updated 7 hours ago

CSV Engineer

Sanofi U.S.

•

Swiftwater, Pennsylvania, USA

Full-time

Job Title: CSV Engineer Location: Swiftwater, PA About the Job We deliver 4.3 billion healthcare solutions to people every year, thanks to the flawless planning and meticulous eye for detail of our Manufacturing & Supply teams. With your talent and ambition, we can do even more to protect people from infectious diseases and bring hope to patients and their families. Our Team/ Overview Sanofi is an innovative global healthcare company with one purpose: to pursue scientific miracles to improv
Posted 60+ days ago | Updated 7 hours ago

Staff Full Stack Software Engineer

General Motors

•

Austin, Texas, USA

Full-time

Job Description Workplace Classification: Hybrid : This role is categorized as hybrid. This means the candidate is expected to report to their primary work location (Austin, TX or Warren, MI) three times per week, at minimum, or other frequency dictated by the business. The Role: The Staff Full Stack Software Engineer is responsible for developing software applications that support the Failure Mode and Effects Analysis (FMEA) business process, spanning the product development lifecycle from Des
Posted 60+ days ago | Updated 4 hours ago

Senior Software Engineer - Mobile

General Motors

•

Austin, Texas, USA

Full-time

Job Description Hybrid: Reporting to a specific location where work needs to be performed / collaboration should happen (regardless this location is within a hub) and without regard to where a candidate lives (some employees may end up hybrid who live more than 50 miles away but where business needs dictate them to be onsite at a specific location three days per week). This role is categorized as hybrid. This means the successful candidate is expected to report to GM Global Technical Center or
Posted 60+ days ago | Updated 4 hours ago