Computer Systems Validation Engineer

1 week ago

Holly Springs, United States Workforce Genetics Full time
Job DescriptionJob Description

We are seeking a CSV Engineer for an 8 month project in the Holly Springs, NC area working for an international professional services and Quality consulting organization, onsite with a biopharma client.

Key Responsibilities:

  • Develop and execute validation protocols for computer software systems used in automated process manufacturing equipment, with a specific focus on DeltaV - controlled systems.

  • Collaborate with engineering, operations, and quality assurance teams to define validation requirements, ensuring alignment with regulatory standards (e.g., FDA, GMP).

  • Perform risk assessments and gap analyses to identify potential areas of concern in the validation process, proposing and implementing mitigation strategies as needed.

  • Generate validation documentation, including validation plans, protocols, reports, and traceability matrices, adhering to established procedures and guidelines.

  • Conduct testing and verification activities, including software installation qualification (SIQ), operational qualification (OQ), and performance qualification (PQ), in accordance with approved protocols.

  • Troubleshoot and resolve validation issues, working closely with technical teams to address any discrepancies or deviations encountered during testing.

  • Maintain validation documentation in a compliant and organized manner, ensuring traceability and accessibility for audits and regulatory inspections.

  • Stay informed about industry trends, regulatory updates, and advancements in validation methodologies, incorporating best practices into our validation processes.

  • Provide technical guidance and mentorship to junior validation engineers, fostering a culture of excellence and continuous improvement within the validation team.


Qualifications:

  • Bachelor's degree in Engineering, Computer Science, or related field. Advanced degree preferred.

  • 8-10 years of experience in computer software validation, with a focus on automated process manufacturing equipment, particularly DeltaV-controlled systems.

  • Proficiency in validation principles and methodologies, with hands-on experience in executing validation protocols in a regulated environment (e.g., FDA, GMP).

  • In-depth knowledge of DeltaV automation platform, including configuration, programming, and troubleshooting capabilities.

  • Familiarity with regulatory requirements and standards governing automated process manufacturing, such as 21 CFR Part 11, GAMP 5, and IEC 62304.

  • Strong analytical and problem-solving skills, with the ability to assess complex technical issues and propose effective solutions.

  • Excellent communication and interpersonal skills, with the ability to collaborate effectively with cross-functional teams and stakeholders.

  • Detail-oriented mindset with a focus on accuracy and compliance in validation documentation and processes.

  • Proven track record of successfully leading validation projects and delivering results on schedule and within budget.

  • Computer Systems Validation Engineer

    8 hours ago

    Holly Springs, United States Workforce Genetics Full time

    Job DescriptionJob DescriptionWe are seeking a CSV Engineer for an 8 month project in the Holly Springs, NC area working for an international professional services and Quality consulting organization, onsite with a biopharma client. Key Responsibilities:Develop and execute validation protocols for computer software systems used in automated process...

  • Specialist II, Validation

    Found in: beBee S US - 2 weeks ago

    Holly Springs, United States CSL Behring Full time

    Do you want to work with a company that tackles fascinating problems and find solutions to complex challenges? Seqirus has an exciting opportunity to join our expanding team in Holly Springs, NC. With an advanced manufacturing facility and expertise in influenza science we are one of the world leaders in the production of the influenza vaccine. We operate as...

  • Specialist II, Validation

    Found in: beBee jobs US - 1 week ago

    Holly Springs, Georgia, United States CSL Behring Full time

    Do you want to work with a company that tackles fascinating problems and find solutions to complex challenges? Seqirus has an exciting opportunity to join our expanding team in Holly Springs, NC. With an advanced manufacturing facility and expertise in influenza science we are one of the world leaders in the production of the influenza vaccine. We operate as...

  • High Performance Computing Systems Administrator

    Found in: beBee jobs US - 2 weeks ago

    Saratoga Springs, New York, United States BAE Systems Full time

    Job Description Unlock the Power of Supercomputing: Join BAE Systems-One of the Leading Service Providers of HPCs.Contribute to one of our longest running programs where we orchestrate the support and sustainment of some of the world's largest and most advanced supercomputers. We are more than just gatekeepers, we are the vanguard of support for the modern...

  • Specialist II/III,

    1 week ago

    Holly Springs, United States Seqirus U.S.A. Inc. Full time

    Specialist II/III, (Validation) - Cleaning page is loaded **Specialist II/III, (Validation) - Cleaning** **Specialist II/III, (Validation) - Cleaning** locationsSeqirus USA - NC - Holly Springs time typeFull time posted onPosted Yesterday job requisition idR-147968 **Job Purpose:** Provides validation lifecycle of processes including: Process validation,...

  • Senior High Performance Computing Systems Administrator with Security Clearance

    Found in: Dice One Red US C2 - 1 week ago

    Saratoga Springs, United States BAE Systems Full time

    Job Description Unlock the Power of Supercomputing: Join BAE Systems-One of the Leading Service Providers of HPCs Contribute to one of our longest running programs where we orchestrate the support and sustainment of some of the world's largest and most advanced supercomputers. We are more than just gatekeepers, we are the vanguard of support for the modern...

  • Senior High Performance Computing Systems Administrator with Security Clearance

    Found in: Dice One Red US C2 - 1 week ago

    Saratoga Springs, United States BAE Systems Full time

    Job Description Unlock the Power of Supercomputing: Join BAE Systems-One of the Leading Service Providers of HPCs Contribute to one of our longest running programs where we orchestrate the support and sustainment of some of the world's largest and most advanced supercomputers. We are more than just gatekeepers, we are the vanguard of support for the modern...

  • High Performance Computing Systems Administrator with Security Clearance

    Found in: Dice One Red US C2 - 1 week ago

    Saratoga Springs, United States BAE Systems Full time

    Job Description Unlock the Power of Supercomputing: Join BAE Systems-One of the Leading Service Providers of HPCs. Contribute to one of our longest running programs where we orchestrate the support and sustainment of some of the world's largest and most advanced supercomputers. We are more than just gatekeepers, we are the vanguard of support for the modern...

  • MES Automation Engineer

    3 days ago

    Holly Springs, United States Piper Companies Full time

    Piper Life Sciences is actively seeking an MES Automation Engineer to join a pharmaceutical organization in the Raleigh, North Carolina area. The Automation Engineer will be leading projects for DeltaV integration, automation validation, and replicating current processes from other company sites. The ideal candidate will have experience with PAS-X....

  • Entry Level Systems Engineer/Controls Specialist

    1 week ago

    Holly Springs, United States RoviSys Full time

    Overview: As a RoviSys Building Technologies employee, you will use the latest control and automation technologies as we provide innovative solutions for our clients. You will design, implement, and configure building automation systems, and/or write custom solutions. We support our customers onsite and from our offices, located across the globe. We use...

  • Senior Automation Engineer

    4 days ago

    Holly Springs, United States Piper Companies Full time

    Piper Life Sciences is actively seeking a Senior Automation Engineer to join a pharmaceutical manufacturing facility that is brand new and going to be the largest end-to-end cell manufacturing facility in Northern America.. The Senior Automation Engineer will be serving as a SME supporting the design and implementation of automation processes. This is a...

  • Computer Systems Analyst

    1 day ago

    Altamonte Springs, United States NavitsPartners Full time

    Job Description Job Description Title: Computer Systems Analyst (Intermediate)Personnel QualificationsA Bachelors degree in Computer Science or a related degree in the IT field or equivalent experience.At least seven (7) years of experience in full SDLC for all task order applications and technologies.Familiarity with Agile methods, DevOps...

  • Senior Automation Engineer

    1 week ago

    Holly Springs, United States Piper Companies Full time

    Piper Life Sciences is actively seeking a Senior Automation Engineer to join a pharmaceutical manufacturing facility that is brand new and going to be the largest end-to-end cell manufacturing facility in Northern America.. The Senior Automation Engineer will be serving as a SME supporting the design and implementation of automation processes. This is a...

  • Computer Systems Analyst

    2 days ago

    Altamonte Springs, United States NavitsPartners Full time

    Job Description Job Description Title: Computer Systems Analyst (Intermediate) Personnel Qualifications A Bachelor’s degree in Computer Science or a related degree in the IT field or equivalent experience. At least seven (7) years of experience in full SDLC for all task order applications and technologies. Familiarity with Agile methods, DevOps...

  • Senior High Performance Computing Systems Administrator with Security Clearance

    Found in: Careerbuilder One Red US C2 - 4 days ago

    Saratoga Springs, UT, United States BAE Systems Full time

    Job Description Unlock the Power of Supercomputing: Join BAE Systems-One of the Leading Service Providers of HPCs Contribute to one of our longest running programs where we orchestrate the support and sustainment of some of the world's largest and most advanced supercomputersWe are more than just gatekeepers, we are the vanguard of support for the modern...

  • Computational Software Engineer

    1 week ago

    Winter Springs, United States CareerBuilder Full time

    We have an opening for a Senior Level Computational Software Engineer in the Winter Springs, FL office. The successful candidate will be part of our Software Development Team and will assist in maintaining, enhancing, and creating new features for our computational framework, working closely with our Software Engineers and the Water Resources Engineering...

  • Computational Software Engineer

    7 days ago

    Winter Springs, United States WGI Inc Full time

    Overview: We have an opening for a Senior Level Computational Software Engineer in the Winter Springs, FL office. The successful candidate will be part of our Software Development Team and will assist in maintaining, enhancing, and creating new features for our computational framework, working closely with our Software Engineers and the Water Resources...

  • Sr. System Test Engineer

    1 week ago

    Colorado Springs, United States CareerBuilder Full time

    Viking Enterprise Solutions has a rich history of leadership in providing storage and storageserver platforms to hyper scale and enterprise data centers worldwide. The division leads themarket with ultra-high capacity and high-end flash systems. Viking Enterprise Solutionsprovides advanced data center products including solid-state memory and disk-based...

  • Lead Computational Software Engineer

    5 days ago

    Winter Springs, United States NextWave Resources Full time

    Lead Computational Software Engineer - Winter Springs, FL Full time (On-site) $120-170k + industry-leading benefit options including Medical, Dental and Vision and many other benefits. Overview: We have an opening for a Senior Level Computational Software Engineer in the Winter Springs, FL office. The successful candidate will be part of our Software...

  • High Performance Computing Systems Administrator with Security Clearance

    Found in: Careerbuilder One Red US C2 - 4 days ago

    Saratoga Springs, UT, United States BAE Systems Full time

    Job Description Unlock the Power of Supercomputing: Join BAE Systems-One of the Leading Service Providers of HPCsContribute to one of our longest running programs where we orchestrate the support and sustainment of some of the world's largest and most advanced supercomputersWe are more than just gatekeepers, we are the vanguard of support for the modern...