gams Jobs

21 - 40 of 53 Jobs

Computer System Validation EngineerJob Title - Computer System Validation Engineer

Katalyst Healthcares and LifesciencesCompany Name - Katalyst Healthcares and Lifesciences

•

San Juan, San Juan, Puerto Rico

Full-time

Roles & Responsibilities: Full lifecycle validation for all applicable computerized systems, ensuring they are designed, validated, operated and retired in compliance with GxP regulation and computer system validation (CSV) guidance. Compiling and maintaining accurate CSV documentation, ensuring full traceability throughout system lifecycles. Compliance Analysis, Validation Planning, Risk Assessments. Test planning and strategy. creation and execution of test protocols, scripts and reports.

Senior Staff, Software Quality Assurance EngineerJob Title - Senior Staff, Software Quality Assurance Engineer

StrykerCompany Name - Stryker

•

Portage, Michigan, USA

Full-time

Work Flexibility: Hybrid Senior Staff, Software Quality Assurance Engineer Stryker is seeking a Senior Staff Software Quality Assurance Engineer to support our Digital Robotics and Enabling Technologies business by driving quality processes. In this role, you will partner with R&D software development teams to guide them through internal quality system processes and ensure compliance with regulatory standards, including FDA, HIPAA, ISO, and SOC 2. Work Flexibility: Hybrid: Candidates must resi

Senior DeltaV Automation EngineerJob Title - Senior DeltaV Automation Engineer

Katalyst Healthcares and LifesciencesCompany Name - Katalyst Healthcares and Lifesciences

•

Muskegon, Michigan, USA

Full-time

Job Description: Are you a DeltaV expert with hands-on experience developing automation code within the DeltaV platform? Do you thrive in a collaborative environment and enjoy mentoring junior engineers? If so, we want to hear from you! Responsibilities: Develop automation code within DeltaV (Control Modules, Equipment Modules, Phases, Recipes). Identify, troubleshoot, and resolve software errors within the DeltaV system. Conduct Factory Acceptance Testing (FAT), Site Acceptance Testing (SAT),

Validation Support EngineerJob Title - Validation Support Engineer

Katalyst Healthcares and LifesciencesCompany Name - 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

Senior Validation EngineerJob Title - Senior Validation Engineer

Katalyst Healthcares and LifesciencesCompany Name - Katalyst Healthcares and Lifesciences

•

Lexington, Massachusetts, USA

Full-time

Responsibilities: Shire Human Genetic Therapies Inc. is seeking a Senior Validation Engineer with the following duties: Write Validation documents per Food Drug Administration (FDA)/Company guidelines; draft Specification documents and Validation Plans (VPs) for pharmaceutical manufacturing and laboratory equipment; Write and execute qualification protocols for new equipment and decommissioning protocols for old equipment. Execute approved protocols per company Good Documentation Practices (cG

Sr. Validation Engineer (CSV)Job Title - Sr. Validation Engineer (CSV)

Katalyst Healthcares and LifesciencesCompany Name - 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

Compliance LeadJob Title - Compliance Lead

Adva IT Services, Inc..Company Name - Adva IT Services, Inc..

•

Remote

Contract

Key Responsibilities Lead the design and execution of the company s compliance framework, covering GxP areas (GMP, Google Cloud Platform, GLP) and validated system lifecycle activities. Ensure compliance with SDLC processes for GxP-relevant computerized systems, including documentation, validation, change control, and audit readiness. Develop and maintain SOPs and training programs related to software/system validation and data integrity (e.g., per 21 CFR Part 11 and Annex 11). Provide complianc

SAP S/4HANA DeveloperJob Title - SAP S/4HANA Developer

MethodHubCompany Name - MethodHub

•

Lake Charles, Louisiana, USA

Full-time

SAP S/4HANA EHS Developer REACH & EPA Integration Expert Location: Onsite Lake Charles, Louisiana Job Type: Fulltime TWIC Card requirement is non-negotiable due to restricted site access.Must be available onsite in Lake Charles, Louisiana, Monday through Friday.Role Summary We are seeking an SAP S/4HANA Environment, Health, and Safety (EHS) Developer with strong regulatory integration experience to support a chemical manufacturing facility with EPA, OSHA, and REACH compliance automation using c

Senior Validation EngineerJob Title - Senior Validation Engineer

Takeda pharmaceuticalCompany Name - 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 Pursuant to Section 20 C.F.R. 656.10, you are hereby notified that an application for Alien Employment Certification will be filed by

Validation EngineerJob Title - Validation Engineer

Abbott LaboratoriesCompany Name - 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. ABOUT ABBOTT Abbott is a global healthcare leader, creating breakthrough science to improve people's health. We're always looking towards the future

Engineer - Syncade or PharmaSuite MES SystemJob Title - Engineer - Syncade or PharmaSuite MES System

Eli Lilly and CompanyCompany Name - 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

Engineer - Syncade or PharmaSuite MES SystemJob Title - Engineer - Syncade or PharmaSuite MES System

LillyCompany Name - Lilly

•

Concord, North Carolina, USA

Full-time

Sr DeltaV Automation Engineer OnsiteJob Title - Sr DeltaV Automation Engineer Onsite

Tektree Systems Inc.Company Name - Tektree Systems Inc.

•

Muskegon, Michigan, USA

Contract, Third Party

Muskegon, MI - onsite daily We need someone who has developed automation code within DeltaV (Control Modules through to Equipment Modules, Phases and Recipes) and familiar with troubleshooting code errors, not just associates with a background in using DeltaV from on operator perspective. This role entails making changes to software, identifying errors and then testing hence Validation profiles will be DISQUALIFIED. Job Summary: This is an onsite role to help with commissioning efforts of a D

Validation Support EngineerJob Title - Validation Support Engineer

Katalyst Healthcares and LifesciencesCompany Name - Katalyst Healthcares and Lifesciences

•

Johns Creek, Georgia, USA

Full-time

Roles & Responsibilities: Validation Planning: Develop/update Master Validation Plans (MVP) and individual Validation Plans (VP) for system changes. Required: Proven expertise in CSV (Computer System Validation) methodologies (e.g., GAMP5), FDA regulations (21 CFR Part 11, 210, 211, 820 as applicable), and validation of automated manufacturing/control systems. Experience validating PLC-based systems (Beckhoff Twin CAT experience is a significant plus). Responsibilities: Perform tasks under S

Commissioning & Qualification (C&Q) EngineerJob Title - Commissioning & Qualification (C&Q) Engineer

Katalyst Healthcares and LifesciencesCompany Name - 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

Computer System Validation Analyst - R Studio & Clinical SystemsJob Title - Computer System Validation Analyst - R Studio & Clinical Systems

Katalyst Healthcares and LifesciencesCompany Name - 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

IDAP MES System Engineer Tech@LillyJob Title - IDAP MES System Engineer Tech@Lilly

Eli Lilly and CompanyCompany Name - Eli Lilly and Company

•

Indianapolis, Indiana, USA

Full-time

Computer System Validation EngineerJob Title - Computer System Validation Engineer

Katalyst Healthcares and LifesciencesCompany Name - 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

SAP Integration LeadJob Title - SAP Integration Lead

Judge Group, Inc.Company Name - 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

Engineer - MES SystemJob Title - Engineer - MES System

Eli Lilly and CompanyCompany Name - Eli Lilly and Company

•

Indianapolis, Indiana, USA

Full-time