Computer System Validation

2 weeks ago

King of Prussia, United States SK Pharmteco Full time
Company Overview:
SK pharmteco (SKPT, the Corporation) is a U.S.-based global Contract Development and Manufacturing Organization (CDMO) that consolidates the operations of sites worldwide - Korea, France, Ireland, and the United States (CA and PA). Built on over 75 years of experience, SK pharmteco is a trusted partner specializing in the manufacture of small molecule APIs and intermediates, viral vectors for gene therapies, cell therapies, registered starting materials, and analytical services for the pharmaceutical industry worldwide.

Position Summary:
The Computer System Validation (CSV) Compliance Specialist – Data Integrity will be responsible for executing validation activities for computer systems and software applications, ensuring compliance with regulatory requirements, industry standards, and company policies. This role involves completing periodic reviews for all GMP systems.
This position is based onsite in King of Prussia, PA.

Primary  Responsibilities:
  • Execute CSV activities in accordance with regulatory requirements (e.g., FDA, EMA, GxP) and industry standards (e.g., GAMP 5).
  • Prepare and review validation documentation to ensure data accuracy, consistency, and reliability within an organizations database systems and processes.
  • Collaborate with cross-functional teams, including IT, Quality Assurance, and Operations, to ensure the life of computerized system remains in a validated state, complies with current regulatory requirements, is fit for intended use, and satisfies company policies and procedures.
  • Identify and troubleshoot validation issues, providing technical support and recommendations for resolution.
  • Maintain accurate and complete validation records and documentation.
  • Support the CSV Manager in planning and coordinating validation projects to ensure timely completion and adherence to project timelines.
  • Participate in continuous improvement initiatives to enhance the CSV process.
Skills and Qualifications:
  • Bachelor's degree in Computer Science, Information Technology, Engineering, Life Sciences, or a related field.
  • 1-3 years of experience in computer system validation within the pharmaceutical, biotechnology, medical device, or related industry.
  • Knowledge of regulatory requirements and industry standards related to CSV (e.g., FDA 21 CFR Part 11, GAMP 5, EU Annex 11).
  • Excellent analytical and problem-solving skills, with a keen attention to detail.
  • Effective communication and interpersonal skills, with the ability to collaborate and build relationships with cross-functional teams.
  • Ability to manage multiple tasks simultaneously and meet deadlines.
  • Ability to work independently and as part of a team, with a proactive and results-oriented approach.
Physical Requirements:
  • Ability to sit for periods of time viewing a computer workstation
Note: This job description is intended to convey information essential to understanding the scope of the job 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 who prohibits discrimination and harassment of any type, and affords equal employment opportunities to employees and applicants.

  • Computer System Validation Specialist

    6 days ago

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

    Company Overview: SK pharmteco is a global Contract Development and Manufacturing Organization (CDMO) with over 75 years of experience. As a trusted partner, we specialize in the manufacture of small molecule APIs, viral vectors, and analytical services for the pharmaceutical industry worldwide. Our operations are consolidated across sites worldwide –...

  • Computer System Validation

    4 days ago

    King of Prussia, United States SK pharmteco Full time

    Company Overview:SK pharmteco (SKPT, the Corporation) is a U.S.-based global Contract Development and Manufacturing Organization (CDMO) that consolidates the operations of sites worldwide - Korea, France, Ireland, and the United States (CA and PA). Built on over 75 years of experience, SK pharmteco is a trusted partner specializing in the manufacture of...

  • SK pharmteco | Computer System Validation

    4 days ago

    king of prussia, United States SK pharmteco Full time

    Company Overview:SK pharmteco (SKPT, the Corporation) is a U.S.-based global Contract Development and Manufacturing Organization (CDMO) that consolidates the operations of sites worldwide - Korea, France, Ireland, and the United States (CA and PA). Built on over 75 years of experience, SK pharmteco is a trusted partner specializing in the manufacture of...

  • SK pharmteco | Computer System Validation

    4 days ago

    king of prussia, United States SK pharmteco Full time

    Company Overview:SK pharmteco (SKPT, the Corporation) is a U.S.-based global Contract Development and Manufacturing Organization (CDMO) that consolidates the operations of sites worldwide - Korea, France, Ireland, and the United States (CA and PA). Built on over 75 years of experience, SK pharmteco is a trusted partner specializing in the manufacture of...

  • Process & Validation Engineer

    4 weeks ago

    king of prussia, United States LAPORTE Full time

    Position Summary:Process & Validation Engineer – King of Prussia, PAThe Process & Validation engineer is responsible for supporting the validation of various systems across the pharmaceutical, biopharmaceutical, and medical device manufacturing areas. The Process & Validation engineer will ensure the equipment/system and validation programs are compliant...

  • Process & Validation Engineer

    4 weeks ago

    King of Prussia, United States LAPORTE Full time

    Position Summary:Process & Validation Engineer – King of Prussia, PAThe Process & Validation engineer is responsible for supporting the validation of various systems across the pharmaceutical, biopharmaceutical, and medical device manufacturing areas. The Process & Validation engineer will ensure the equipment/system and validation programs are compliant...

  • Process & Validation Engineer

    3 weeks ago

    king of prussia, United States LAPORTE Full time

    Position Summary:Process & Validation Engineer – King of Prussia, PAThe Process & Validation engineer is responsible for supporting the validation of various systems across the pharmaceutical, biopharmaceutical, and medical device manufacturing areas. The Process & Validation engineer will ensure the equipment/system and validation programs are compliant...

  • Senior Systems Engineer

    6 days ago

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

    OverviewArcfield, a leading provider of full lifecycle systems engineering and integration capabilities to the US government and its allies, offers a challenging opportunity for a skilled System Engineer. Headquartered in Chantilly, VA, with 16 offices worldwide, Arcfield employs approximately 1,200 professionals who put customers' missions first.Job...

  • Senior Technical Systems Analyst

    2 days ago

    King of Prussia, Pennsylvania, United States Arcfield Full time

    Overview of Arcfield">Arcfield is a leading provider of innovative digital transformation solutions, space mission engineering services, and cybersecurity expertise. With over 60 years of collective experience in supporting missions in cyber and space defense, space exploration, hypersonic and nuclear deterrence, and warfighter readiness, we employ more than...

  • QMS System Implementation

    4 weeks ago

    King of Prussia, United States CSL Full time

    The OpportunityKey Measures of Success- Business Administration of QMS Platforms: System changes, internal and platform releases are well managed and status reports is provided anytime in a clear and easy understandable way.- End-users / process owners/ power users / key users of QMS Platforms are well supported.- Successful collaboration with all partners...

  • Head of Lab Execution Systems

    1 month ago

    King of Prussia, United States CSL Behring Full time

    The OpportunityThe Senior Director, Head of Lab Execution Systems (LES) will lead our Systems support across our Quality Control labs that help produce commercial and clinical trial materials. This includes enterprise systems such as STARLIMS, LabWare, Empower, Nugenesis, and Chromeleon, along with local QC lab instrument applications. Your work also...

  • Head of Lab Execution Systems

    1 month ago

    King of Prussia, United States CSL Behring Full time

    The OpportunityThe Senior Director, Head of Lab Execution Systems (LES) will lead our Systems support across our Quality Control labs that help produce commercial and clinical trial materials. This includes enterprise systems such as STARLIMS, LabWare, Empower, Nugenesis, and Chromeleon, along with local QC lab instrument applications. Your work also...

  • Head of Lab Execution Systems

    1 month ago

    King of Prussia, United States CSL Behring Full time

    The OpportunityThe Senior Director, Head of Lab Execution Systems (LES) will lead our Systems support across our Quality Control labs that help produce commercial and clinical trial materials. This includes enterprise systems such as STARLIMS, LabWare, Empower, Nugenesis, and Chromeleon, along with local QC lab instrument applications. Your work also...

  • Head of Lab Execution Systems

    1 month ago

    King of Prussia, United States CSL Behring Full time

    The OpportunityThe Senior Director, Head of Lab Execution Systems (LES) will lead our Systems support across our Quality Control labs that help produce commercial and clinical trial materials. This includes enterprise systems such as STARLIMS, LabWare, Empower, Nugenesis, and Chromeleon, along with local QC lab instrument applications. Your work also...

  • Head of Lab Execution Systems

    1 month ago

    King of Prussia, United States CSL Behring Full time

    The OpportunityThe Senior Director, Head of Lab Execution Systems (LES) will lead our Systems support across our Quality Control labs that help produce commercial and clinical trial materials. This includes enterprise systems such as STARLIMS, LabWare, Empower, Nugenesis, and Chromeleon, along with local QC lab instrument applications. Your work also...

  • Head of Lab Execution Systems

    4 weeks ago

    King of Prussia, United States CSL Behring Full time

    The OpportunityThe Senior Director, Head of Lab Execution Systems (LES) will lead our Systems support across our Quality Control labs that help produce commercial and clinical trial materials. This includes enterprise systems such as STARLIMS, LabWare, Empower, Nugenesis, and Chromeleon, along with local QC lab instrument applications. Your work also...

  • Hypersonic Systems Engineer

    1 week ago

    King of Prussia, Pennsylvania, United States Leidos Full time

    Lead Hypersonic System Developer OpportunityWe are seeking an experienced Hypersonic Systems Engineer to lead system development and modeling and simulation efforts in our King of Prussia, PA office.About the RoleThis senior engineering position involves integrating multiple design concepts and defining analysis and test roadmaps to validate performance of...

  • Head of Lab Execution Systems, Senior Director

    3 weeks ago

    King of Prussia, United States CSL Behring Full time

    Job DescriptionThe OpportunityThe Senior Director, Head of Lab Execution Systems (LES) will lead our Systems support across our Quality Control labs that help produce commercial and clinical trial materials. This includes enterprise systems such as STARLIMS, LabWare, Empower, Nugenesis, and Chromeleon, along with local QC lab instrument applications. Your...

  • Head of Lab Execution Systems, Senior Director

    3 weeks ago

    King Of Prussia, United States CSL Behring Full time

    The OpportunityThe Senior Director, Head of Lab Execution Systems (LES) will lead our Systems support across our Quality Control labs that help produce commercial and clinical trial materials. This includes enterprise systems such as STARLIMS, LabWare, Empower, Nugenesis, and Chromeleon, along with local QC lab instrument applications. Your work also...

  • Head of Lab Execution Systems, Senior Director

    3 weeks ago

    King Of Prussia, United States CSL Behring Full time

    The OpportunityHit Apply below to send your application for consideration Ensure that your CV is up to date, and that you have read the job specs first.The Senior Director, Head of Lab Execution Systems (LES) will lead our Systems support across our Quality Control labs that help produce commercial and clinical trial materials. This includes enterprise...