CSV Engineer

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

Location: King of Prussia (onsite)

Company: SK Pharmteco

The Computer System Validation (CSV) Engineer 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 preparing validation documentation, conducting validation testing, and supporting cross-functional teams in achieving validation objectives.

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, including validation plans, protocols, and report.
• Conduct and document risk assessments to identify potential validation issues and develop mitigation strategies.
• Perform validation testing, including installation qualification (IQ), operational qualification (OQ), and performance qualification (PQ).
• Collaborate with cross-functional teams, including IT, Quality Assurance, and Operations, to ensure successful validation of computer systems and software applications.
• 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.
• Stay current with industry trends, regulatory changes, and best practices related to computer system validation.
• Assist in the preparation for regulatory inspections and audits, including presenting validation documentation and addressing inquiries.
• Participate in continuous improvement initiatives to enhance the CSV process.

Requirements:

• Level II- Minimum of 2- 3 years of experience in computer system validation within the pharmaceutical, biotechnology, medical device, or related industry.
• Level IV/SR- 5-8 years of experience in computer system validation within the pharmaceutical, biotechnology, medical device, or related industry.
• Strong knowledge of regulatory requirements and industry standards related to CSV (e.g., FDA 21 CFR Part 11, GAMP 5, EU Annex 11).
• Experience with the validation of various computer systems, including ERP systems, LIMS, MES, and other software applications.
• 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.
• 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-oriented approach.
• Certification in computer system validation or quality management (e.g., ASQ, ISPE) is a plus.
• Bachelor’s degree in Computer Science, Information Technology, Engineering, Life Sciences, or a related field.

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., an equal opportunity employer who prohibits discrimination and harassment of any type, and affords equal employment opportunities to employees and applicants