Validation Engineer I

Responsible for validation activities at the designated Sharp facility, including equipment, process, and facilities qualifications, temperature mapping, and ensuring compliance with current good manufacturing practices. The role involves coordination with Internal Operations, Sales, Engineering, Quality Assurance, and customers, and may be based in Macungie, Conshohocken, or Allentown.

Responsibilities

• Support the validation program by contributing to development of validation approach, design, and execution.
• Write ES/IQ/OQ/PQ protocols for equipment and systems within cGMP guidelines.
• Participate in URS, FAT, SAT, and engineering studies as requested.
• Write PV protocols specific to customer needs and Sharp requirements.
• Communicate validation approach and requirements with customers.
• Execute validation protocols and review results.
• Prepare summary reports of executed protocols.
• Provide support for customer and external regulatory audits related to validation activities.
• Coordinate execution of validation activities at the designated facility, including packaging, HVAC, equipment qualification, processes, facilities, and utilities.
• Coordinate the work of Validation Technicians and provide directions during ES, IOQ, or PQ activities.

Qualifications

• Bachelor’s degree in a technical discipline (BS/BA) preferred; three to five years related experience or equivalent combination of education and experience.
• Independent certification of advanced quality skills (e.g., ASQ, CQE, Six Sigma) required.
• Knowledge of current validation principles, FDA regulations, cGMPs, and validation guidance documents.
• Understanding of basic engineering principles, equipment automation controls, and quality/attribute sampling plans (e.g., ANSI Z1.4).
• Ability to structure validation protocols in conformance with a planned validation approach.
• Excellent written and oral communication skills.
• Strong organizational, planning, and multi‑tasking abilities; ability to work independently and meet project deadlines.
• Familiarity with quality engineering practices in packaging operations (desired).
• Relevant ASQ certification (desired).

Physical Demands

• Regular use of hands to handle equipment, write, and communicate.
• Frequent sitting; occasional standing, walking, and reaching.
• Occasional lifting or moving of up to 20 pounds.
• Vision requirements: close, distance, and ability to adjust focus.
• Travel to local sites in all weather conditions.

Work Environment

• Primarily desk work with regular visits to the shop floor and packaging equipment.
• Clean environment, not normally hazardous.
• Approximately 5 % auto travel between sites; travel to customers, equipment suppliers, and international FATs as needed.
• Passport required for international travel.

Disclaimer

This job description is not designed to cover or contain a comprehensive listing of activities, duties, or responsibilities required of the employee. Duties, responsibilities, and activities may change, or new ones may be assigned at any time with or without notice.