Current jobs related to Senior Computer System Validation Specialist - King of Prussia, Pennsylvania - SK pharmteco

  • Senior Systems Analyst

    3 days ago

    King of Prussia, Pennsylvania, United States Arcfield Full time

    Job SummaryArcfield is seeking a highly skilled Senior Systems Analyst to join our team. As a key member of our team, you will be responsible for performing technical planning, system integration, verification and validation, cost and risk, and effectiveness analyses for total systems.Key ResponsibilitiesPerform technical planning, system integration,...

  • Senior Systems Engineer

    3 days ago

    King of Prussia, Pennsylvania, United States Analex Corporation dba Arcfield Full time

    Job SummaryArcfield is seeking a highly skilled Senior Systems Engineer to join our team. As a key member of our engineering team, you will be responsible for performing technical planning, system integration, verification and validation, cost and risk, and effectiveness analyses for total systems.Key ResponsibilitiesPerform technical planning, system...

  • Senior Systems Engineer

    3 days ago

    King of Prussia, Pennsylvania, United States Analex Corporation dba Arcfield Full time

    Job Summary:Arcfield is seeking a highly skilled Senior Systems Engineer to join our team. As a key member of our engineering team, you will be responsible for performing technical planning, system integration, verification and validation, cost and risk, and effectiveness analyses for total systems.Key Responsibilities:Perform technical planning, system...

  • Senior Systems Engineer

    1 week ago

    King of Prussia, Pennsylvania, United States Analex Corporation dba Arcfield Full time

    Job SummaryWe are seeking a highly skilled Senior Systems Engineer to join our team at Analex Corporation dba Arcfield. As a key member of our engineering team, you will be responsible for performing technical planning, system integration, verification and validation, cost and risk, and effectiveness analyses for total systems.Key Responsibilities:Perform...

  • Senior Systems Engineer

    1 week ago

    King of Prussia, Pennsylvania, United States Analex Corporation dba Arcfield Full time

    Job Summary:Arcfield is seeking a highly skilled Senior Systems Engineer to join our team. As a key member of our engineering team, you will be responsible for performing technical planning, system integration, verification and validation, cost and risk, and effectiveness analyses for total systems.Key Responsibilities:Perform technical analysis to support...

  • Senior Validation Engineer

    4 weeks ago

    King of Prussia, Pennsylvania, United States EPM Scientific Full time

    CQV Engineer Job DescriptionWe are seeking a highly skilled CQV Engineer to join our team at EPM Scientific in Philadelphia. Our client, a leading pharmaceutical company, is looking for an expert to support their operations in the development and distribution of innovative medications.Key Responsibilities:Perform Installation Qualification (IQ), Operational...

  • Senior Care Specialist

    3 days ago

    King of Prussia, Pennsylvania, United States Always Best Care Senior Service Full time

    We are seeking a dedicated and compassionate Senior Care Specialist to join our team at Always Best Care Senior Services. As a Home Health Aide, you will play a vital role in providing exceptional in-home care to our clients, ensuring their comfort, safety, and well-being.Key Responsibilities:Assist with activities of daily living, including bathing,...

  • Senior Project Manager

    3 weeks ago

    King of Prussia, Pennsylvania, United States Vertex Computer Systems Full time

    Job Title: Technical Project ManagerVertex Computer Systems is a leading provider of Salesforce consulting and implementation services. Our team is dedicated to delivering innovative solutions that meet our clients' unique needs and exceed their expectations.Job Summary:We are seeking a highly skilled Technical Project Manager to lead our medium to...

  • Senior Manufacturing Systems Engineer

    4 weeks ago

    King of Prussia, Pennsylvania, United States GSK Full time

    Job Title: Senior Manufacturing Systems EngineerWe are seeking a highly skilled Senior Manufacturing Systems Engineer to join our team at GSK. As a key member of our engineering team, you will be responsible for providing technical support and expertise in the design, implementation, and maintenance of our manufacturing execution systems (MES).Key...

  • Senior Enterprise Project Manager

    3 days ago

    King of Prussia, Pennsylvania, United States Vertex Computer Systems Full time

    Vertex Computer Systems Overview:We are a leading provider of Salesforce consulting and implementation services, helping businesses leverage the power of Salesforce to streamline operations, improve customer relationships, and drive growth. Our team is dedicated to delivering innovative solutions that meet our clients' unique needs and exceed their...

  • Senior Technical Analyst

    2 days ago

    King of Prussia, Pennsylvania, United States Arcfield Full time

    Job SummaryAt Arcfield, we are seeking a highly skilled Senior Technical Analyst to join our team. As a key member of our engineering team, you will be responsible for performing technical planning, system integration, verification and validation, cost and risk, and effectiveness analyses for total systems.Key Responsibilities* Performs technical planning,...

  • Senior Systems Engineer

    2 days ago

    King of Prussia, Pennsylvania, United States Lockheed Martin Corporation Full time

    Unlock Your Potential as a Senior Systems EngineerJoin Lockheed Martin Space, a pioneer in the aerospace industry, as a Senior Systems Engineer. In this role, you will be part of an Agile team focused on IT Infrastructure, working on exciting projects that advance the frontiers of science and help militaries protect what matters most.Key...

  • QMS System Implementation Specialist

    1 week ago

    King of Prussia, Pennsylvania, United States CSL Behring Full time

    Job SummaryWe are seeking a highly skilled QMS System Implementation Specialist to join our team at CSL Vifor. The successful candidate will be responsible for coordinating the implementation of quality management systems, ensuring compliance with regulatory requirements, and providing excellent support to end-users.Key ResponsibilitiesCoordinate the...

  • Senior Technical Analyst

    1 week ago

    King of Prussia, Pennsylvania, United States Arcfield Full time

    Job SummaryArcfield is seeking a highly skilled Senior Technical Analyst to join our team. As a key member of our engineering team, you will be responsible for performing technical planning, system integration, verification and validation, cost and risk, and effectiveness analyses for total systems.Key ResponsibilitiesPerform technical planning, system...

  • Technical Project Lead

    2 weeks ago

    King of Prussia, Pennsylvania, United States Vertex Computer Systems Full time

    Vertex Computer Systems is a leading provider of Salesforce consulting and implementation services. Our team is dedicated to delivering innovative solutions that meet our clients' unique needs and exceed their expectations.Key Responsibilities:• Manage medium to large scale enterprise wide projects, mobilizing resources from different teams, defining...

  • Senior Underwriting Specialist

    6 days ago

    King of Prussia, Pennsylvania, United States GeoBlue Full time

    Job Summary:The Senior Underwriting Specialist will employ advanced underwriting concepts to determine rate development for all group UW cases. This role requires the ability to skillfully apply current models to rate development, as well as advise and participate in the refinement and expansion of these models. The employee will establish and apply company...

  • Software Development Specialist

    3 weeks ago

    King of Prussia, Pennsylvania, United States NexPro Technologies Inc Full time

    Job DescriptionAt NexPro Technologies Inc, we are seeking a skilled Software Development Specialist to join our team.Key Responsibilities:Create, modify, and test software code, forms, and scripts.Write, update, and maintain computer programs.Perform test runs to ensure compatibility with various software programs.Collaborate with software engineers and...

  • Aerospace Systems Engineer

    3 weeks ago

    King of Prussia, Pennsylvania, United States Arcfield Full time

    Job Title: Aerospace EngineerArcfield is a leading provider of full lifecycle, mission-focused systems engineering and integration capabilities to the U.S. government and its allies.We have over 60 years of proven experience providing advanced engineering and analysis, IT and C5ISR capabilities to support our nation's most critical national security...

  • Senior Systems Engineer

    4 weeks ago

    King of Prussia, Pennsylvania, United States ARKA Group Full time

    Job Title: Systems Engineer Job Summary: ARKA Group L.P. is seeking a highly skilled Systems Engineer to join our team. As a Systems Engineer, you will be responsible for designing, developing, and testing complex software applications. You will work closely with cross-functional teams to ensure that our software meets the highest standards of quality and...

  • Senior Electrical Engineer

    6 days ago

    King of Prussia, Pennsylvania, United States Remington & Vernick Engineers Full time

    Job DescriptionRemington & Vernick Engineers is seeking a senior-level Electrical Engineer with expertise in electrical power, lighting, and fire alarm/systems design for public, institutional, educational, commercial, and industrial facilities. The ideal candidate will have experience in developing and managing electrical departments to support MEP and...

Senior Computer System Validation Specialist

2 months ago

King of Prussia, Pennsylvania, United States SK pharmteco Full time

Position: CSV Engineer (Level II and Level IV/Sr)

Company: SK Pharmteco

The role of the Computer System Validation (CSV) Engineer encompasses the execution of validation tasks for computer systems and software applications, ensuring adherence to regulatory standards, industry practices, and internal protocols. This position requires the preparation of validation documentation, conducting validation assessments, and collaborating with various teams to meet validation goals.

Key Responsibilities:

  • Implement CSV activities in line with regulatory guidelines (e.g., FDA, EMA, GxP) and industry best practices (e.g., GAMP 5).
  • Draft and evaluate validation documentation, including validation strategies, testing protocols, and final reports.
  • Conduct and document risk evaluations to pinpoint potential validation challenges and devise mitigation plans.
  • Execute validation assessments, including installation qualification (IQ), operational qualification (OQ), and performance qualification (PQ).
  • Work closely with cross-functional teams, such as IT, Quality Assurance, and Operations, to guarantee effective validation of computer systems and software.
  • Identify and resolve validation challenges, offering technical support and recommendations for solutions.
  • Maintain thorough and accurate validation records and documentation.
  • Assist the CSV Manager in organizing and managing validation projects to ensure timely execution and compliance with project schedules.
  • Stay informed about industry developments, regulatory updates, and best practices in computer system validation.
  • Support preparations for regulatory inspections and audits, including presenting validation documentation and addressing inquiries.
  • Engage in continuous improvement initiatives to refine the CSV process.

Qualifications:

  • Level IV/SR- 5-8+ years of experience in computer system validation within the pharmaceutical, biotechnology, medical device, or related sectors.
  • In-depth knowledge of regulatory standards and industry practices related to CSV (e.g., FDA 21 CFR Part 11, GAMP 5, EU Annex 11).
  • Experience in validating various computer systems, including ERP systems, LIMS, MES, and other software applications.
  • Strong analytical and problem-solving abilities, with meticulous attention to detail.
  • Excellent communication and interpersonal skills, capable of collaborating and building relationships with diverse teams.
  • Ability to manage multiple tasks concurrently and meet deadlines.
  • Proficient in creating and maintaining validation documentation.
  • Familiarity with risk assessment and mitigation techniques.
  • Capacity to work independently and as part of a team, with a proactive and results-driven mindset.
  • Certification in computer system validation or quality management (e.g., ASQ, ISPE) is advantageous.
  • Bachelor's degree in Computer Science, Information Technology, Engineering, Life Sciences, or a related discipline.

This job description is designed to provide essential information regarding the scope of the role. It is not intended to be an exhaustive list of qualifications, responsibilities, and skills required. Additional duties may be assigned as necessary.

SK Pharmteco Inc. is an equal opportunity employer that prohibits discrimination and harassment of any kind and provides equal employment opportunities to all employees and applicants.