Job Description

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.

 

Job Tags

Full time, Contract work, Worldwide,

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