Computer Serialization Validation Engineer.

Sharp Services; Macungie (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 enhance their validation processes within the pharmaceutical manufacturing sector. This role involves developing and implementing computer validation activities, ensuring compliance with industry standards and regulations. The successful candidate will collaborate with various departments to create serialization technology solutions and validate computer systems across multiple platforms. If you are passionate about quality assurance and have a strong background in computer validation, this opportunity is perfect for you to make a significant impact in a dynamic environment.

Qualifications

• 5-7 years of experience in computer validation and GMP systems.
• Knowledge of FDA regulations and validation principles.

Responsibilities

• Support computer validation program and develop validation plans.
• Supervise validation activities and participate in audits.

Skills

Computer Validation

GMP Compliance

FDA Regulations

Quality Engineering

Excellent Written Communication

Education

Bachelor’s Degree in Technical Discipline

Tools

Microsoft Office

Job description

Computer Serialization Validation Engineer

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Job Overview

Responsible for developing and implementing computer validation activities related to computerized GMP systems and technology within commercial and clinical Sharp locations. Utilizes a system development lifecycle approach, applying industry guidance (USP, EMEA, HC, ICH) and knowledge of 21CFR-part 11 requirements to ensure compliance. Collaborates with Engineering, IT, Technical Services, Project Management, Operations, Sales, and Quality Assurance to develop serialization technology solutions and validate computer systems across multiple platforms to meet client needs and industry standards.

Location

Scope includes Allentown, Bethlehem, Conshohocken, and Macungie. Primary location depends on the individual’s hiring location, with expected travel between sites.

Key Responsibilities

• Support the computer validation program by contributing to validation approach development, design, and execution.
• Develop and implement CSV master plans.
• Develop and write IQ/OQ/PQ protocols and complete validation activities, including requirements analysis, traceability matrix, summary reports, and CSV assessments.
• Communicate validation approaches and requirements with customers and internal teams.
• Supervise validation activities at designated facilities, including serialized packaging and validation of computer systems, environmental monitoring, quality systems, networking, and equipment qualifications.
• Participate in customer and regulatory audits related to computer validation.
• Review protocols and write final reports.
• Support audits and external regulatory reviews as needed.

Qualifications

• Bachelor’s degree in a technical discipline preferred, with 5-7 years of related experience or equivalent.
• Knowledge of FDA regulations, cGMPs, industry practices, and computer validation guidance (including 21CFR-part 11).
• Understanding of quality engineering, validation principles, and manufacturing practices.
• Ability to structure validation protocols in conformance with validation plans.
• Familiarity with ISO 9000 (beneficial).
• Excellent written communication skills.
• Proficiency in Microsoft Office; certifications from ASQ or ISPE are beneficial.

Additional Information

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