Validation Engineer I: GMP‑Driven, Cross‑Site Impact

Sharp Clinical Services; Allentown (Lehigh County); On-site; USD 65,000 - 90,000; Full time

Job summary

Sharp Clinical Services seeks a Validation Engineer I to perform equipment, process and facilities qualification activities under the Validation Manager. Work may include temperature mapping and cGMP-compliant execution at designated sites.

The role requires collaboration with Operations, Engineering, QA and customers, writing ES/IQ/OQ/PQ protocols, coordinating activity, and supporting audits. Travel to local sites and occasional international FATs may be required.

Qualifications

• Bachelor’s degree in a technical discipline from a four-year college.
• Experience writing ES/IQ/OQ/PQ protocols per cGMP.
• Knowledge of FDA regulations and cGMP guidance documents.

Responsibilities

• Write ES/IQ/OQ/PQ protocols for equipment and systems.
• Execute and review validation protocols and write summary reports.
• Coordinate validation activities across Sharp facilities and with customers.
• Support internal and external audits related to validation.

Skills

Bachelor’s degree

ASQ certification

FDA/cGMP knowledge

Protocol writing

Project coordination

Education

Bachelor’s degree in technical discipline

ASQ CQE/Six Sigma cert preferred

Job description

Sharp Clinical Services seeks a Validation Engineer I to perform equipment, process and facilities qualification activities under the Validation Manager. Work may include temperature mapping and cGMP-compliant execution at designated sites.

The role requires collaboration with Operations, Engineering, QA and customers, writing ES/IQ/OQ/PQ protocols, coordinating activity, and supporting audits. Travel to local sites and occasional international FATs may be required.