Validation Engineer I: Drive Equipment & Process Validation

Sharp Corporation; Allentown (Lehigh County); On-site; USD 75,000 - 110,000; Full time

Job summary

Sharp Packaging Services seeks a Validation Specialist to lead execution of validation activities for equipment, processes, and facilities, aligned with cGMP and guided by the Validation Manager. The role may cover multiple sites including Macungie, Conshohocken or Allentown, with the work located at one designated site.

You will write and review IQ/OQ/PQ protocols, support audits, and coordinate with Internal Operations, Sales, Engineering, and QA to ensure regulatory compliance and customer

Qualifications

• Bachelor’s degree in technical discipline (BS/BA) preferred with three to five years related experience.
• Independent certification in advanced quality skills (ASQ, CQE, Six Sigma) preferred.
• Knowledge of FDA regulations, cGMPs, and validation guidance documents.
• Ability to structure validation protocols per a planned approach.
• Familiarity with ANSI Z1.4 sampling plans; strong written communication.
• Ability to plan, schedule, and multi-task validation activities.

Responsibilities

• Develop and write ES/IQ/OQ/PQ protocols for equipment and systems per cGMP.
• Support validation program design and execution.
• Participate in URS, FAT, SAT and engineering studies as requested.
• Coordinate validation activities across Sharp facilities (Macungie, Conshohocken, Allentown).
• Review executed protocols and write summary reports.
• Support customer and regulatory audits related to validation.

Skills

ASQ CQE Six Sigma

Validation principles

Engineering principles

Quality sampling plans

Written communication

Oral communication

Project planning & multitasking

Independent work ethic

Education

Bachelor's degree in technical discipline

Job description

Sharp Packaging Services seeks a Validation Specialist to lead execution of validation activities for equipment, processes, and facilities, aligned with cGMP and guided by the Validation Manager. The role may cover multiple sites including Macungie, Conshohocken or Allentown, with the work located at one designated site.

You will write and review IQ/OQ/PQ protocols, support audits, and coordinate with Internal Operations, Sales, Engineering, and QA to ensure regulatory compliance and customer