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Computer System Validation Manager Jobs in Delaware

Fusion Life Sciences

System Engineers

Newark, DE · On-site

System Engineer Location: Newark, DE Long Term Contract Job Overview: We are seeking highly skilled ... Proven ability to ensure full traceability from user needs to design validation and manage product ...

Owens Community College

Applicant Pool for Adjunct Faculty, Computer Programming and Networking Technology/Information ... Uses the College's course management system for assigned courses and department matters as ...

Morris & Ritchie Associates, Inc.

CAD Designer

Newark, DE · On-site

$26.50 - $36.50/hr

... drainage systems, sediment and erosion control plans, grading plans, utility layouts, and ... Experience in drafting civil engineering plans, including grading, utilities, stormwater management ...

Morris & Ritchie Associates, Inc.

CAD Designer

Newark, DE

$26.50 - $36.50/hr

... drainage systems, sediment and erosion control plans, grading plans, utility layouts, and ... Experience in drafting civil engineering plans, including grading, utilities, stormwater management ...

Morris & Ritchie Associates, Inc.

CAD Designer

Newark, DE · On-site

$26.50 - $36.50/hr

... drainage systems, sediment and erosion control plans, grading plans, utility layouts, and ... Experience in drafting civil engineering plans, including grading, utilities, stormwater management ...

EMG Acquisitions

Store Manager - Dover

Dover, DE · On-site

The Store Manager's responsibilities include but not limited to maintaining effective operation and ... Ensure office staff fully comprehends their and understands our computer system. * Maintain an on ...

EMG Acquisition Group

Store Manager - Dover

Dover, DE

The Store Manager's responsibilities include but not limited to maintaining effective operation and ... Ensure office staff fully comprehends their and understands our computer system. * Maintain an on ...

GameStop Inc

Store Manager (Store 4256)

Newark, DE · On-site

The Store Manager is responsible for all facets of store operations and directly influences the ... computer system via PC keyboard, including making correct change, placing merchandise in a bag ...

GameStop

Store Manager (Store 4256)

Newark, DE · On-site

$21 - $29/hr

The Store Manager is responsible for all facets of store operations and directly influences the ... computer system via PC keyboard, including making correct change, placing merchandise in a bag ...

Driftwood Hospitality Management

Night Auditor

Wilmington, DE · On-site

$14.50 - $19.50/hr

Driftwood Hospitality Management is renowned for our fully integrated approach to hospitality ... Complete the registration process by inputting and retrieving information from a computer system ...

Christiana Care Health Services

$19.10 - $27.69/hr

Nurse Manager Assistant Nurse Manager Receives direction from RN staff EDUCATION AND EXPERIENCE ... Knowledge of CCHS computer systems. Electronic medical health record, and programs used in ...

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Computer System Validation Manager information

What are the key skills and qualifications needed to thrive as a Computer System Validation Manager, and why are they important?

To thrive as a Computer System Validation Manager, you need expertise in computer system validation regulations (such as GxP, FDA 21 CFR Part 11), strong project management skills, and a background in life sciences or IT. Familiarity with validation lifecycle documentation tools, quality management systems (QMS), and compliance software is often required, along with relevant certifications like PMP or CSV-related credentials. Exceptional attention to detail, analytical thinking, and effective communication are crucial soft skills for coordinating cross-functional teams and ensuring regulatory compliance. These skills and qualifications are vital to ensure validated systems meet regulatory standards, minimize compliance risks, and support organizational quality objectives.

What are some common challenges a Computer System Validation Manager faces during system implementation projects?

A Computer System Validation Manager often encounters challenges such as aligning validation activities with evolving regulatory requirements, managing tight project timelines, and coordinating between multiple stakeholders like IT, Quality Assurance, and business users. Ensuring thorough documentation and traceability, while adapting to technology updates or scope changes, can also be demanding. Proactive communication and strong project management skills are essential to mitigate risks and ensure successful, compliant system implementations.

What does a Computer System Validation Manager do?

A Computer System Validation Manager is responsible for ensuring that computer systems used in regulated industries, such as pharmaceuticals or biotechnology, meet all required compliance standards. They oversee the planning, execution, and documentation of validation activities to ensure systems are reliable, accurate, and secure. Their duties include managing validation projects, writing protocols, coordinating with IT and quality assurance teams, and ensuring adherence to regulations like FDA 21 CFR Part 11. This role is critical for maintaining product quality and regulatory compliance.

What is the difference between Computer System Validation Manager vs Computer System Validation Specialist?

AspectComputer System Validation ManagerComputer System Validation Specialist
CertificationsGAMP, CQE, CSQEGAMP, CQE, CSQE
Work EnvironmentManagement, oversight, strategic planningExecution, testing, documentation
Industry UsagePharmaceutical, biotech, regulated industriesPharmaceutical, biotech, regulated industries
Primary FocusLeading validation projects, team coordinationPerforming validation activities, testing

The main difference between a Computer System Validation Manager and a Computer System Validation Specialist lies in their roles. The manager oversees validation projects, manages teams, and ensures compliance, while the specialist executes validation tasks and documents testing procedures. Both roles require similar certifications and are vital in regulated industries like pharmaceuticals and biotech.

What are popular job titles related to Computer System Validation Manager jobs in Delaware? For Computer System Validation Manager jobs in Delaware, the most frequently searched job titles are:
What job categories do people searching Computer System Validation Manager jobs in Delaware look for? The top searched job categories for Computer System Validation Manager jobs in Delaware are:
What cities in Delaware are hiring for Computer System Validation Manager jobs? Cities in Delaware with the most Computer System Validation Manager job openings:
Computer System Validation Manager jobs near you
Infographic showing various Computer System Validation Manager job openings in Delaware as of July 2026, with employment types broken down into 57% Full Time, and 43% Contract. Highlights an 100% In-person job distribution.
System Engineers

System Engineers

Fusion Life Sciences

Newark, DE • On-site

Contractor

Re-posted 10 days ago

Job description

Title: System Engineer

Location: Newark, DE

Long Term Contract
 

Job Overview:

We are seeking highly skilled and experienced System Engineers to join our team. The ideal candidate will have 5-8 years of experience in the medical device industry, with a strong focus on Design Controls, traceability, and design validation. This individual will play a critical role in ensuring that user needs are clearly traced to design inputs, verification, and validation throughout the product development lifecycle.

Key Responsibilities:

  • Design Controls: Lead efforts to develop and implement robust design control processes for new and existing products, ensuring compliance with FDA regulations (21 CFR 820), ISO 13485, and other relevant industry standards.
  • Traceability: Establish and maintain traceability throughout the design and development phases, ensuring that user needs, design inputs, and verification requirements are fully traced and documented.
  • User Needs to Design Validation: Work cross-functionally to trace user needs to design validation, ensuring that final products meet both the defined requirements and user expectations. This includes the development of comprehensive Design History Files (DHF) and validation documentation.
  • Design Verification & Validation (V&V): Collaborate with teams to ensure that all products undergo thorough design verification and design validation processes, providing evidence that the product meets the necessary specifications.
  • Cross-Functional Collaboration: Work closely with other engineering disciplines, such as hardware, software, and quality teams, to ensure a seamless integration of design controls and traceability throughout the product lifecycle.
  • Documentation and Reporting: Prepare and maintain detailed documentation for design control processes, ensuring all deliverables are compliant with internal and regulatory standards. Provide updates to leadership and stakeholders on project status, risks, and timelines.
  • Continuous Improvement: Identify areas for process improvements in design control and traceability methods, and implement changes that enhance the efficiency and effectiveness of product development.

Required Qualifications:

  • Experience: 5-8 years of experience in system engineering within a regulated environment, preferably in medical devices or other highly regulated industries.
  • Design Controls: Strong experience in implementing and managing design controls processes, including traceability, user needs, and design verification/validation.
  • Traceability: Proven ability to ensure full traceability from user needs to design validation and manage product documentation accordingly.
  • Regulatory Knowledge: In-depth knowledge of FDA regulations (21 CFR 820), ISO 13485, and other applicable standards for medical devices.
  • Collaboration: Strong communication and interpersonal skills, with experience working effectively in cross-functional teams.
  • Strong verbal and written communication in English

Preferred Qualifications:

  • Risk Management: Experience with risk management processes, including risk analysis, risk assessment, and mitigation strategies (e.g., ISO 14971).
  • V&V Experience: Familiarity with verification and validation techniques and methodologies for ensuring that product designs meet both functional and regulatory requirements.
  • Software and Tools: Experience with requirements management tools, traceability software, and common V&V tools.

Personal Attributes:

  • Strong analytical and problem-solving skills
  • Ability to manage and prioritize multiple tasks in a fast-paced environment
  • Detail-oriented with a commitment to accuracy
  • Proactive and able to work independently or as part of a team
    Sincerely,
    Subash Kondala
    Medical/Pharma Recruiter
    www.fusionlifesolutions.com 
    Subash@fusionlifesolutions.com
    Direct Number: (312)447-9550
    linkedin.com/in/subash-kondala-a5a39424a
    For all jobs with Fusion https://tinyurl.com/56f356a3
    6110 McFarland Station Dr Suite 502 Alpharetta GA 30004