Computer Systems Validation Engineer III

4 weeks ago


West Chester, Pennsylvania, United States Resilience Corp. Full time

Job Summary:

The Computer Systems Validation Engineer III will be responsible for ensuring the validation of digital systems at Resilience Corp. This includes developing and implementing a risk-based validation program, collaborating with stakeholders, and ensuring compliance with regulatory requirements.

Key Responsibilities:

  • Develop and implement a risk-based validation program for digital systems
  • Collaborate with stakeholders, including system owners, process owners, quality, engineering, and manufacturing
  • Ensure compliance with regulatory requirements, including 21 CFR Part 11 and EU Annex 11
  • Develop and maintain computer system lifecycle documentation, including validation plans, business process maps, and user acceptance tests
  • Partner with quality to ensure change controls, deviations, and CAPAs are closed on time
  • Design and deliver training to digital sites on data integrity, computer systems assurance, and traditional CSV
  • Support internal and external audits of digital systems

Requirements:

  • Extensive experience in federally regulated industries or CSV teams in Pharmaceutical/Biotech industry
  • Strong working knowledge of GxP, 21 CFR Parts 11, and Annex 11 compliance requirements
  • Fluid collaboration skills across business, digital, and external vendors/suppliers
  • Enhanced technical writing skills with attention to detail and excellent communication skills

Preferred Qualifications:

  • B.S. degree in Computer Science, Engineering, or related field with 7+ years of relevant progressive experience
  • Knowledge and understanding of risk assessment tools
  • Fluency in supporting the digitization of Computer Software Assurance processes

About Resilience Corp.:

Resilience Corp. is a technology-focused biomanufacturing company that's changing the way medicine is made. We're building a sustainable network of high-tech, end-to-end manufacturing solutions to better withstand disruptive events, serve scientific discovery, and reach those in need.



  • West Chester, Pennsylvania, United States Resilience Corp. Full time

    Job DescriptionA career at Resilience is more than just a job - it's an opportunity to change the future.Resilience is a technology-focused biomanufacturing company that's changing the way medicine is made. We're building a sustainable network of high-tech, end-to-end manufacturing solutions to better withstand disruptive events, serve scientific discovery,...


  • West Chester, Pennsylvania, United States Cummins-Wagner Co Inc Full time

    We are seeking an exceptional Mechanical Systems Engineer to join our team in West Chester, Pennsylvania. This is a rewarding opportunity for someone who thrives in a fast-paced environment and is passionate about designing and implementing innovative mechanical systems.Job DescriptionThe successful candidate will be responsible for the following key...

  • Financial Clerk III

    1 month ago


    West Chester, Pennsylvania, United States County of Chester Full time

    Job Title: Financial Clerk IIIJoin us at the County of Chester as a skilled and detail-oriented Financial Clerk III. This exciting opportunity offers a competitive salary and comprehensive benefits package.About UsThe County of Chester is a dynamic organization dedicated to providing exceptional public services to our community. As a member of our team, you...


  • West Chester, Pennsylvania, United States Cummins-Wagner Co Inc Full time

    Cummins-Wagner Co Inc is a dynamic company that represents industry-leading manufacturers of pumps, air compressors, vacuum, and heat transfer equipment.Job Description:The Project Manager leads in the quotation, design, procurement, fabrication, and testing of packaged systems for commercial and industrial applications.This role requires a minimum of 5...


  • West Chester, Pennsylvania, United States ITAC Full time

    Discover a challenging and rewarding career as an Electrical Design Engineer at ITAC, where you'll be part of a collaborative team driving innovation in electrical engineering design.We're seeking an experienced Electrical Design Engineer to join our dynamic team, responsible for performing electrical engineering activities across all phases of development...


  • West Chester, Pennsylvania, United States Cummins-Wagner Co Inc Full time

    Job OverviewCummins-Wagner's Engineered Process Solutions division is looking for a full-time Engineering Manager to oversee the engineering and design teams. The successful candidate will lead a team of engineers and designers to develop and implement custom packaged systems for commercial and industrial applications.About the RoleThis is a challenging and...

  • Electrical Engineer

    2 weeks ago


    West Chester, Pennsylvania, United States ITAC Full time

    Electrical Engineer JobWe are seeking a skilled Electrical Engineer to join our team. This role involves installing, maintaining, and repairing electrical systems and equipment in industrial settings.Key Responsibilities:Install, maintain, and repair electrical systems and equipmentInspect electrical systems for hazards or faultsTroubleshoot electrical...


  • West Chester, Pennsylvania, United States ITAC Full time

    Company Overview">We are ITAC, a leading provider of integrated engineering and construction services for complex capital projects. Our Power Systems Division is a regional leader in designing, manufacturing, installing, and servicing industrial control and power system equipment. We serve Fortune 500 clients throughout the Carolinas and...


  • West Chester, Pennsylvania, United States E Tech Group Full time

    Job Title: Automation Engineering Expert\About E Tech Group: As a leading engineering and system integration firm in the United States, we provide value to our clients through IT automation and control solutions for over 25 years.\We are seeking an experienced Automation Engineering Expert to perform process automation engineering and system integration...


  • West Chester, Pennsylvania, United States Cypress HCM Full time

    A product design engineer at Cypress HCM is required to conceive and implement the development of innovative aluminum access solutions. The ideal candidate will have a strong background in mechanical engineering and experience with 3D CAD software.Key responsibilities include designing parts, fixtures, and tooling using computer-assisted design/drafting...


  • West Chester, Pennsylvania, United States Transwall Office Systems, Inc. Full time

    Transwall Office Systems, Inc. is a leading developer and manufacturer of moveable floor-to-ceiling and architectural wall systems based in West Chester, PA. As a financially stable and expanding mid-sized company, we offer a casual yet vibrant work environment with a leadership team focused on long-term employee growth and development.The estimated salary...


  • West Chester, Pennsylvania, United States Transwall Office Systems, Inc. Full time

    Transwall Office Systems, Inc. is a leading developer and manufacturer of moveable floor-to-ceiling and architectural wall systems based in West Chester, PA. As a financially stable and expanding mid-sized company, we offer a casual yet vibrant work environment with a leadership team focused on long-term employee growth and development.About the SalaryThe...


  • West Chester, Pennsylvania, United States Transwall Office Systems, Inc. Full time

    We are seeking an experienced executive leader to join our team as Vice President of Sales and Efficiency. This is an excellent opportunity for someone who is passionate about driving salesforce efficiency and productivity.About the CompanyTranswall Office Systems, Inc. is a dynamic and growing company based in West Chester, PA. We are a leading developer...


  • West Chester, Pennsylvania, United States Cummins-Wagner Co Inc Full time

    Job Title: Engineering ManagerCummins-Wagner Co Inc is seeking a highly skilled Engineering Manager to lead our Packaged Systems Design team. This role will oversee the design, development, and implementation of custom packaged systems for commercial and industrial applications.About Cummins-Wagner Co IncCummins-Wagner Co Inc is a 100% Employee-Owned Company...


  • West Chester, Pennsylvania, United States E Tech Group Full time

    Job Overview:\E Tech Group is a leading engineering and system integration firm in the United States. We have been providing value to our clients through IT automation and control solutions for over 25 years.\We are currently seeking a Control System Integration Lead to join our team. This individual will be responsible for leading project teams responsible...


  • West Chester, Pennsylvania, United States SAIIA Full time

    Project Engineer Role at SaiiaThe Project Engineer plays a key role in the success of Saiia's construction projects. Reporting directly to the Project Manager, the ideal candidate will have a strong background in project engineering, with experience in daily reports, quantity tracking, project scheduling, budget updates, correspondence logs, and requests for...


  • West Chester, Pennsylvania, United States ITAC Full time

    **Job Overview:** Process Engineering Specialist**Estimated Salary:** $130,000 - $160,000 per yearWe are seeking a highly skilled Process Engineering Specialist to join our team at ITAC. As a Process Engineering Specialist at ITAC, you will be responsible for optimizing mechanical designs for industrial processes.**Job Responsibilities:**We are looking for a...


  • West Chester, Pennsylvania, United States Cummins-Wagner Co Inc Full time

    Cummins-Wagner Co. Inc., a 100% Employee-Owned Company, is seeking an experienced Engineering Manager to lead the Engineering Process Solutions (EPS) division. This position oversees the engineering and design teams responsible for packaged systems quoting, design, drawings, and submittals.Responsibilities:Manage the Application Engineering, Design/Drafting,...


  • West Chester, Pennsylvania, United States ITAC Full time

    About Us">At ITAC, we are committed to delivering exceptional results for our clients. Our Power Systems Division offers a wide range of engineering and construction services, including the design, manufacture, installation, and servicing of industrial control and power system equipment.">Salary">The estimated salary for this position is $22-$29 per hour,...


  • West Chester, Pennsylvania, United States trak group Full time

    Job DescriptionWe are seeking a highly skilled Industrial Maintenance Engineer to join our team. In this role, you will be responsible for performing maintenance on manufacturing equipment, including box makers, palletizers, and extrusion lines.About the RolePerform routine maintenance tasks to ensure equipment is operational and running...