Senior Validation Engineer — cGMP & Regulatory Expert

Sharp Corporation; United States; On-site; USD 90,000 - 130,000; Full time

Job summary

Sharp Packaging Services seeks a senior validation professional to lead planning and execution of validation activities across packaging, cleaning, HVAC and computer systems. The role supports the Validation Manager and collaborates with Operations, Sales, Engineering and QA to ensure compliance with cGMP and FDA regulations.

The position covers both Conshohocken and Allentown facilities, located at a single site as required, with travel to customer sites and suppliers as needed.

Qualifications

• Bachelor’s degree in a technical field; 6–10 years related experience or training.
• Certification in quality disciplines (ASQ, CQE, Six Sigma) preferred.
• Knowledge of FDA regulations and cGMP is required.
• Familiarity with quality engineering in manufacturing is required.
• Ability to plan and schedule validation activities independently.

Responsibilities

• Support validation manager in developing validation approaches and execution.
• Review and approve change controls involving equipment and processes.
• Complete validation reviews and approve master production records.
• Develop validation requirements for new equipment, processes, facilities, or products.
• Write IQ/OQ/PQ protocols per cGMP guidelines.
• Supervise validation activities at designated Sharp facilities (packaging, cleaning, HVAC, computer systems).
• Write PV protocols tailored to customer needs and communicate with customers.
• Monitor and execute validation protocols; review and finalize reports.
• Participate in customer and external regulatory audits as needed.

Skills

Validation planning

Regulatory knowledge

Change control oversight

Documentation writing

Project coordination

Multi-tasking

Communication with customers

Quality systems familiarity

Education

B.S./B.A. in technical discipline

Tools

Pilgrim SmartSolve

Lotus Notes

Microsoft Office

Job description

Sharp Packaging Services seeks a senior validation professional to lead planning and execution of validation activities across packaging, cleaning, HVAC and computer systems. The role supports the Validation Manager and collaborates with Operations, Sales, Engineering and QA to ensure compliance with cGMP and FDA regulations.

The position covers both Conshohocken and Allentown facilities, located at a single site as required, with travel to customer sites and suppliers as needed.