Senior Validation Engineer for Computer Systems

2 weeks ago


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

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

Location: King of Prussia (onsite)

Company: SK Pharmteco

The Computer System Validation (CSV) Engineer is tasked with executing validation processes for computer systems and software applications, ensuring adherence to regulatory standards, industry guidelines, and internal policies. This role encompasses the preparation of validation documentation, execution of validation testing, and collaboration with cross-functional teams to meet validation goals.

Key Responsibilities:

  • Implement CSV activities in line with regulatory standards (e.g., FDA, EMA, GxP) and industry guidelines (e.g., GAMP 5).
  • Draft and review validation documentation, including validation plans, protocols, and reports.
  • Conduct and document risk assessments to pinpoint potential validation challenges and devise mitigation strategies.
  • Carry out validation testing, which includes installation qualification (IQ), operational qualification (OQ), and performance qualification (PQ).
  • Work closely with cross-functional teams, such as IT, Quality Assurance, and Operations, to ensure effective validation of computer systems and software applications.
  • Identify and resolve validation issues, providing technical support and recommendations for solutions.
  • Maintain comprehensive and accurate validation records and documentation.
  • Assist the CSV Manager in planning and coordinating validation projects to ensure timely completion and adherence to project schedules.
  • Stay informed about industry trends, regulatory updates, and best practices related to computer system validation.
  • Support the preparation for regulatory inspections and audits, including presenting validation documentation and addressing inquiries.
  • Engage in continuous improvement initiatives to enhance 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.
  • Strong understanding of regulatory standards and industry guidelines pertaining 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.
  • Exceptional analytical and problem-solving abilities, with a strong attention to detail.
  • Effective communication and interpersonal skills, capable of collaborating and building relationships with cross-functional teams.
  • Ability to manage multiple tasks concurrently and meet deadlines.
  • Proficiency in creating and maintaining validation documentation.
  • Familiarity with risk assessment and mitigation strategies.
  • Ability to work independently and as part of a team, with a proactive and results-driven approach.
  • 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.

Note: This job description aims to convey essential information regarding 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 that prohibits discrimination and harassment of any kind, providing equal employment opportunities to all employees and applicants.



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

    Position: CSV Engineer (Level II and Level IV/Sr)Location: King of Prussia (onsite)Company: SK PharmtecoThe Computer System Validation (CSV) Engineer is tasked with overseeing validation processes for software applications and computer systems, ensuring adherence to regulatory standards, industry benchmarks, and internal protocols. This role encompasses the...


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

    Position: CSV Engineer (Level II and Level IV/Sr)Location: King of Prussia (onsite)Company: SK PharmtecoThe Computer System Validation (CSV) Engineer plays a crucial role in executing validation tasks for computer systems and software applications, ensuring adherence to regulatory standards, industry guidelines, and internal policies. This position entails...


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

    Position: CSV Engineer (Level II and Level IV/Sr)Location: King of Prussia (onsite)Company: SK PharmtecoThe Computer System Validation (CSV) Engineer is tasked with overseeing validation processes for computer systems and software solutions, ensuring adherence to regulatory frameworks, industry benchmarks, and organizational protocols. This role encompasses...


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

    Position: CSV Engineer (Level II and Level IV/Sr)Company: SK PharmtecoThe 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...


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

    Position: CSV Engineer (Level II and Level IV/Sr)Company: SK PharmtecoThe Computer System Validation (CSV) Engineer plays a crucial role in overseeing validation processes for computer systems and software applications, ensuring adherence to regulatory standards, industry guidelines, and internal policies. This position involves the preparation of validation...


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

    Position Overview: Senior IT Project CoordinatorVertex Computer Systems, a prominent technology firm with over 15 years of expertise in Microsoft, Salesforce, Business Intelligence, Artificial Intelligence, and Cloud Solutions, is seeking a Senior IT Project Coordinator. Our commitment to fostering enduring client partnerships has established us as a...


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

    Position Overview:Vertex Computer Systems is seeking a Senior IT Project Manager to oversee and guide a range of significant technology initiatives. With over 15 years of expertise in Microsoft, Salesforce, Business Intelligence, Artificial Intelligence, and Cloud Solutions, Vertex has established itself as a reliable partner for clients, delivering...


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

    About the RoleThis is a challenging and rewarding opportunity to join Lockheed Martin's team as a Senior Systems Engineer - Survivability Engineering. As a key member of our Systems Engineering, Integration, and Test (SEIT) Specialty Engineering team, you will be responsible for ensuring the survivability of our missile systems in various environments.Key...


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

    Position Overview:Vertex Computer Systems is a well-established technology firm with extensive expertise in Microsoft, Salesforce, Business Intelligence, Artificial Intelligence, and Cloud Solutions. We pride ourselves on our enduring partnerships with clients, consistently delivering innovative solutions that address intricate business challenges.Role...


  • King of Prussia, Pennsylvania, United States CV Library Full time

    Key Responsibilities:As a Senior Test Systems Engineer, you will play a pivotal role in guiding teams through Application, System, and Integration Testing processes. Your expertise will ensure the effective evaluation of Geospatial-intelligence systems across various agencies, delivering timely and precise GEOINT.Core Duties:Lead and mentor system engineers...


  • King of Prussia, Pennsylvania, United States Herbert Rowland & Grubic Full time

    About the RoleWe are seeking a highly skilled Senior Water and Wastewater Project Engineer to join our team at Herbert Rowland & Grubic. As a Senior Water and Wastewater Project Engineer, you will be responsible for leading complex water and wastewater projects, providing technical expertise to clients, and collaborating with our team of professionals.Key...


  • King of Prussia, Pennsylvania, United States GlaxoSmithKline Full time

    About the RoleWe are seeking a highly skilled Automation Systems Engineer to join our team at GlaxoSmithKline. As an Automation Systems Engineer, you will play a critical role in designing, planning, and implementing changes to control systems used in our daily operations.Key ResponsibilitiesProvide technical support for site automation systems and network...


  • King of Prussia, Pennsylvania, United States Apex Systems Full time

    Position OverviewA leading organization in the defense and aerospace sector is seeking to recruit a Systems Engineer with a TS/SCI Polygraph security clearance.Location: Fort Belvoir, VA (Position involves shift work)Compensation: Competitive salary based on experience - ($120k to $190k)Security Clearance Required: TS/SCI with an active PolygraphEssential...


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

    About the RoleThis is an exciting opportunity to join Lockheed Martin's Space Security Division as a Senior Cybersecurity Engineer. As a key member of our team, you will play a critical role in protecting our nation's space capabilities and ensuring the security of our systems.Key ResponsibilitiesDevelop and implement cybersecurity strategies to mitigate...


  • King of Prussia, Pennsylvania, United States Peraton Full time

    Position Overview: Test Systems EngineerKey ResponsibilitiesFacilitate the leadership of Application, System, and Integration Testing teams across multiple sectors to guarantee precise and timely GEOINT.Provide guidance to system engineers at various levels regarding testing and evaluation processes.Supervise the assessment of applications and APIs within...


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

    Position Overview: Join Lockheed Martin Space, a leader in the aerospace industry, where innovation meets excellence. We are at the forefront of a new era in space exploration, dedicated to solving some of the most intricate engineering challenges of our time.Our talented team is committed to making a significant impact globally by leveraging our diverse...


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

    Position Overview:Join Lockheed Martin Space, a leader in aerospace innovation, where we are committed to pushing the boundaries of technology and engineering.Our talented team is dedicated to addressing some of the most intricate engineering challenges facing our world today. We foster a culture that encourages creativity, excellence, and the development of...


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

    Job SummaryThis is a challenging and rewarding opportunity to lead a team of systems engineers and be responsible for technical management, planning, risk management, resource deployment, and staffing for the dedicated Reentry W93/Mk7 Systems Engineering group within the Fleet Ballistic Missile (FBM) Reentry Systems Engineering organization.Key...

  • Senior RF Engineer

    3 days ago


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

    About Lockheed MartinLockheed Martin is a leading technology innovation company that works with partners around the world to bring proven performance to our customers' toughest challenges.Job SummaryWe are seeking a highly skilled Senior RF Engineer to join our team. The successful candidate will be responsible for designing and analyzing RF circuits and...


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

    Product ManagerVertex Computer Systems is a US-based technology company with 15 years of experience in Microsoft, Salesforce, Business Intelligence, Artificial Intelligence, and Cloud Computing. We have built long-term relationships with clients as trusted partners. Our team inspires, innovates, and implements solutions that solve complex business problems...