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Sr. Engineer - Software

Popular Tech

•

Thousand Oaks, California, USA

Full-time

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 clinical/commercial facility. 3) Familiarity with industry standards
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Posted 19 days ago | Updated 18 days ago

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
Posted 30 days ago | Updated 7 hours ago

Manager, QC Laboratory Systems Engineer

ProKidney Corp.

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Winston-Salem, North Carolina, USA

Full-time

Job DescriptionPosition Summary: The Manager, QC Laboratory Systems Engineer is responsible for supporting laboratory instrumentation and computerized systems within a GMP-regulated environment, with a strong focus on data integrity. This role acts as a subject matter expert (SME) and system administrator for instruments and systems used in QC testing, Analytical and Microbiological Analysis (GMA) instruments. The engineer provides technical oversight, manages qualification activities, and ensur
Posted 1 day ago | Updated 3 hours ago

Life Sciences Solutions Architect

Evergreen

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Atlanta, Georgia, USA

Full-time

Job DescriptionSummary: The Life Sciences Solution Architect will play a critical role in pre-sales engagement, solution design, development of commercial terms, contract negotiations and closing activities for programs in life sciences. This individual will serve as the subject matter expert for validation programs as well as Commissioning, Qualification, and Validation(CQV) and Analytical Instrument Qualification (AIQ) that bridge validation compliance with digital transformation efforts, ena
Posted 1 day ago | Updated 5 hours ago

Sr. Validation Engineer (CSV)

Katalyst Healthcares and Lifesciences

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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
Posted 46 days ago | Updated 7 hours ago

Validation Engineer

Katalyst Healthcares and Lifesciences

•

Rockford, Illinois, USA

Full-time

Responsibilities: Perform validation activities to ensure compliance with government and customer requirements. Prepare and execute validation protocols (IOQ, OQ/PQ) and related documentation for new customer/product/system launches. Maintain existing validated processes, coordinating internal and customer approvals as needed. Ensure validation documentation is complete, accurate, and properly closed, including organizing and coordinating multiple approvals. Assist in the change control pro
Posted 46 days ago | Updated 7 hours ago

Manager R&D Quality Risk Management- Princeton

Irvine Technology Corporation (ITC)

•

Princeton, New Jersey, USA

Contract

Manager, R&D Quality Risk Management - Hybrid- Princeton, NJ Join our client as a Manager, R&D Quality Risk Management, where you ll play a pivotal role in overseeing computer system validation (CSV) activities across GxP systems. This position offers the opportunity to work in a highly regulated environment, collaborate cross-functionally, and ensure systems comply with evolving global standards in data integrity and compliance. If you thrive in a quality-driven, dynamic R&D environment, this
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Posted 5 days ago | Updated 1 hour ago

Validation Engineer

Primary Talent Partners

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East Syracuse, New York, USA

Contract

Primary Talent Partners has an open 12 month W2 contract with a large biologics client of ours in the Syracuse, NY area.Pay Range: $52.00 to $57.00 per hour (No PTO, benefits, etc but self funded ACA-compliant healthcare plan available to opt-in to) Job ResponsibilitiesResponsible for preparing computer system validation documents to comply with local and global regulatory requirements, and internal company standards. Ensure IT personnel complete QMS actions and routine system compliance activ
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Posted 3 days ago | Updated 3 days ago

Sr Automation Specialist

Unique System Skills LLC

•

Cambridge, Ontario, Canada

Full-time

Job Description Job Title: Senior Automation Specialist Location: Cambridge, Ontario, Canada Reports to: Engineering Lead Company Overview: We provide a broad range of engineering services including: Electrical EngineeringControls Design & DraftingPLC/HMI ProgrammingRobot ProgrammingSite Startup and Commissioning SupportProject ManagementMaintenance Training & Operator ManualsPre-Start Health & Safety ReviewsPosition Summary: As a Senior Automation Specialist, you will be accountable to the Eng
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Posted 3 days ago

Automation Lead

Arcadis

•

Holly Springs, North Carolina, USA

Full-time

Job DescriptionAbout The Job Arcadis is the world's leading company delivering sustainable design, engineering, and consultancy solutions for natural and built assets. We are more than 36,000 people, in over 70 countries, dedicated to improving quality of life. Everyone has an important role to play. With the power of many curious minds, together we can solve the world s most complex challenges and deliver more impact together. About the Role: Arcadis is seeking an experienced and strategic Auto
Posted 11 days ago | Updated 6 hours ago

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 46 days ago | Updated 7 hours ago

MES Consultant

BOTG LLC

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Remote

Full-time

Location: Remote Job Type: Full-Time / Contract Industry: Life Sciences / Pharmaceuticals / Manufacturing About the Role: We are seeking experienced MES (Manufacturing Execution System) Consultants with strong backgrounds in Electronic Batch Records (EBR) and Master Batch Record (MBR) design, along with hands-on recipe authoring experience. This is a remote position, ideal for professionals with a solid understanding of GMP-regulated environments, especially in pharmaceutical or biotech manufact
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Posted 55 days ago | Updated 18 days ago

Principal Engineer

ApTask

•

Thousand Oaks, California, USA

Full-time

Job DescriptionIdeal candidate: Must have background in within Life sciences specifically Biotechnology and Biomedical Engineering. Emerson Delta-V DCS Programming Experience, Rockwell Automation SCADA and PLC Experience, Compliance with regulatory requirements such as 21 CFR Part 11Minimum of Bachelors Degree in Electrical Engineering or Computer Science, Chemical Engineering, Biotech Engineering, or related life science engineering. Client Manufacturing and Clinical Supply (MCS) Facilities & E
Posted 1 day ago | Updated 17 hours ago

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
Posted 13 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 46 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 10 days ago | Updated 7 hours ago

Sr DeltaV Automation Engineer

Amaeyaa Technologies Inc

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Muskegon, Michigan, USA

Third Party, Contract

Top Must Have's: Strong Process Automation project & commissioning experience with the DeltaV platform in a Pharma/Biotech environment. Familiarity with ISA 88, GAMP, cGAMP Clear understanding of Software Development Life Cycle (SDLC), Agile methodologies, automation C&Q activities.
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Posted 2 days ago

Sr DeltaV Automation Engineer

Intone Networks Inc.

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Michigan, USA

Full-time, Contract, Third Party

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
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Posted 4 days ago | Updated 1 day ago

Senior Packaging Development Engineer Pharma/OTC

Global IT Family

•

Jersey City, New Jersey, USA

Contract

Hi This is the requirement from TCS. Please share resume of your candidate for this below requirement at Job Title-Senior Packaging Development Engineer Pharma/OTC Location- Iselin, NJ(South) TCS Contract position: A minimum of 8-10 years of industry experience is required with at least 3 years of Package Development experience. Specific experience within the Consumer, OTC, or Pharmaceutical industry is must. GMP experience is must. Experience in a highly regulated environment is preferred. Dem
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Posted 2 days ago

Senior Automation Engineer

Aegis Worldwide

•

St. Louis, Missouri, USA

Full-time

Job DescriptionJob Title: Senior Automation Engineer Location: St.Louis, MO Department: Engineering / Automation & Controls We are seeking a highly skilled and experienced Senior Automation Engineer to lead the development, implementation, and support of automated systems in our nuclear medicine manufacturing facility. This role is critical in ensuring the efficiency, safety, and compliance of systems used in the production of radiopharmaceuticals. The ideal candidate will have deep expertise
Posted 11 days ago | Updated 6 hours ago