Computer Serialization Validation Engineer

This role is responsible for the development and implementation of computer validation activities related to computerized GMP systems and technology within commercial and clinical Sharp locations. Utilization of a system development lifecycle approach, applying industry guidance (USP, EMEA, HC, ICH) with knowledge of 21CFR-part 11 requirements to ensure compliance of all systems. Working with Engineering, IT, Technical Services, Project Management, Operations, Sales and Quality Assurance to develop and implement serialization technology solutions and computer systems validation across multiple platforms to meet client needs and industry standards.

Scope of the position includes Allentown, Bethlehem, Conshohocken and Macungie. Primary location will be dependent on location of individual at time of hiring with the expectation that commuting between locations can/will be required.

ESSENTIAL DUTIES AND RESPONSIBILITIES: The following is a list of minimum responsibilities related to this position. Other duties may be assigned.

Support the computer validation program by contributing to development of validation approach, design and execution. Development and implementation of CSV master plan.

Develop and write IQ/OQ/PQ protocols and complete validation activities that may include:

• Requirements analysis
• Traceability Matrix
• Summary report
• CSV Assessments for appropriate equipment and systems within the guidelines of cGMP. Execution of protocols at designated sites as needed.
• Responsible for communicating computer validation approach and requirements with customers and internal staff.
• Responsible for supervising the execution of validation activities at designated Sharp facility which involves but not limited to serialized packaging, and computer systems validation including environmental monitoring systems, quality systems, networking, and baseline equipment qualifications.
• Participate in customer/regulatory audits specific to computer validation activity at all Sharp facilities at the direction of the CSV Supervisor.
• Review executed protocols and write final reports as required.
• Provide support for customer audits and external regulatory audits specific to computer validation activity at all Sharp facilities at the direction of the CSV Supervisor.

EDUCATION and/or EXPERIENCE:

Bachelor’s degree in technical discipline (BS/BA) from a four-year college or university preferred with five to seven years related experience and or training; or equivalent combination of education and experience.

• Knowledge of FDA regulations including cGMPs, current industry practice and computer validation guidance documents including 21CFR-part11.
• Knowledge and understanding of quality engineering, operations and validation principles and practices.
• Ability to structure validation protocols in conformance with a planned validation approach is required.
• Familiarity with ISO 9000 (beneficial)