Validation Engineer I: cGMP Compliance Focus

Sharp Services, LLC; Allentown (Lehigh County); On-site; USD 70,000 - 90,000; Full time

Job summary

Sharp Services, LLC seeks a Validation Engineer I to oversee and execute validation activities across equipment, processes, and facilities in line with cGMP. The role includes protocol writing (ES/IQ/OQ/PQ), conducting URS/FAT/SAT, and coordinating with internal teams and customers.

Responsibilities include developing validation approaches, executing protocols, and delivering summary reports; travel to local sites and collaboration with Quality Assurance and Sales are expected.

Qualifications

• Knowledge of FDA regulations, cGMPs, and validation guidance documents.
• Knowledge of basic engineering principles and equipment automation controls.
• Ability to structure validation protocols in conformance with a planned validation approach.
• Familiarity with quality engineering practices in packaging operations is desired.
• Independent certification of advanced quality skills (ASQ, CQE, Six Sigma) is desirable.

Responsibilities

• Support the validation program by contributing to development of validation approach, design and execution.
• Write ES/IQ/OQ/PQ protocols for appropriate equipment and systems; participate in URS, FAT, SAT and Engineering Studies.
• Write PV protocols per Sharp requirements and customer needs.
• Coordinate validation activities and communicate validation requirements with customers.
• Review executed protocols and write summary reports; provide support for customer audits.

Skills

Written communication

Oral communication

Planning & scheduling

Multi-tasking

Independent work

Education

Bachelor's degree in technical discipline

ASQ CQE / Six Sigma certification (desirable)

Job description

Sharp Services, LLC seeks a Validation Engineer I to oversee and execute validation activities across equipment, processes, and facilities in line with cGMP. The role includes protocol writing (ES/IQ/OQ/PQ), conducting URS/FAT/SAT, and coordinating with internal teams and customers.

Responsibilities include developing validation approaches, executing protocols, and delivering summary reports; travel to local sites and collaboration with Quality Assurance and Sales are expected.