Computer Serialization Validation Engineer

Sharp Services; Allentown (Lehigh County); On-site; USD 70,000 - 110,000; Full time

Job summary

An established industry player is seeking a Computer Serialization Validation Engineer to join their team. This role involves developing and implementing computer validation activities related to GMP systems across various locations. The ideal candidate will have a strong background in FDA regulations and computer validation guidance, working collaboratively with multiple departments to ensure compliance. If you are passionate about quality assurance in the pharmaceutical manufacturing sector and have a knack for developing effective validation protocols, this opportunity is perfect for you.

Qualifications

• 5-7 years of experience in computer validation and GMP compliance.
• Strong knowledge of FDA regulations and 21CFR-part 11.

Responsibilities

• Develop and implement validation activities for GMP systems.
• Conduct assessments and supervise validation activities.

Skills

Computer Validation

GMP Compliance

FDA Regulations

Quality Engineering

ISO 9000

Education

Bachelor’s Degree in Technical Discipline

Job description

Computer Serialization Validation Engineer

Join us to apply for the Computer Serialization Validation Engineer role at Sharp Services.

Role Overview

This position involves developing and implementing computer validation activities related to GMP systems and technology within Sharp's commercial and clinical locations. The role requires a system development lifecycle approach, applying industry guidance (USP, EMEA, HC, ICH) and knowledge of 21CFR-part 11 to ensure system compliance. Collaboration with Engineering, IT, Technical Services, Project Management, Operations, Sales, and Quality Assurance is essential to develop serialization technology solutions and validate computer systems across multiple platforms.

The scope includes locations in Allentown, Bethlehem, Conshohocken, and Macungie, with primary location depending on the hire's current location. Some commuting between locations may be required.

Essential Duties and Responsibilities

• Support the computer validation program by developing validation approaches, designs, and executing validation activities.
• Develop and write IQ/OQ/PQ protocols and complete validation activities, including requirements analysis, traceability matrix, and summary reports.
• Conduct CSV assessments for equipment and systems within cGMP guidelines.
• Communicate validation approaches and requirements with customers and internal staff.
• Supervise validation activities at designated facilities, including serialized packaging, environmental monitoring, quality systems, networking, and equipment qualifications.
• Participate in customer/regulatory audits related to computer validation.
• Review protocols and write final reports.
• Support audits at all Sharp facilities as directed.

Qualifications

• Bachelor’s degree in a technical discipline (BS/BA) preferred, with 5-7 years of related experience or equivalent.
• Knowledge of FDA regulations, cGMP, and computer validation guidance including 21CFR-part 11.
• Understanding of quality engineering, validation principles, and practices.
• Ability to structure validation protocols in conformance with validation plans.
• Familiarity with ISO 9000 is beneficial.

Additional Details

• Seniority Level: Mid-Senior level
• Employment Type: Full-time
• Job Function: Quality Assurance
• Industry: Pharmaceutical Manufacturing