Validation Engineer I: Quality & Equipment Validation

Sharp Services, LLC; Allentown, Northern (Lehigh County, KY); Hybrid; USD 70,000 - 110,000; Full time

Job summary

Sharp Services, LLC is seeking a Validation Engineer I for Allentown, PA. The role supports validation programs across Sharp facilities, including packaging, HVAC, and equipment qualification, ensuring cGMP compliance and timely project delivery.

You will write IQ/OQ/PQ/PV protocols, participate in URS, FAT, SAT, and engineering studies, and coordinate validation activities with internal teams and customers. Strong documentation and communication skills are essential.

Qualifications

• Bachelor’s degree in technical discipline with 3–5 years related experience or equivalent
• Independent certification of advanced quality skills (ASQ, CQE, Six Sigma) required
• Knowledge of FDA regulations, cGMPs and validation guidance documents
• Knowledge of basic engineering principles and equipment automation controls
• Ability to structure validation protocols per planned approach
• Familiarity with sampling plans (ANSI Z1.4)
• Excellent written and oral communication skills
• Ability to plan, schedule, and multi-task validation activities
• Ability to work independently and meet deadlines
• Familiarity with quality in packaging operations is desired

Responsibilities

• Support validation program by developing validation approach, design, and execution
• Write ES/IQ/OQ/PQ protocols per cGMP guidelines
• Participate in URS, FAT, SAT and Engineering Studies
• Write PV protocols per customer needs and Sharp requirements
• Coordinate validation activities at Sharp facilities (packaging, HVAC, equipment qualification)
• Review executed protocols and write summaries
• Support customer and regulatory audits related to validation
• Communicate validation approach with customers and schedule activities

Skills

Validation protocols

Quality systems

Documentation

Communication skills

Education

Bachelor’s degree in technical discipline

ASQ/CQE/Six Sigma certification

Tools

ANSI Z1.4 familiarity

Job description

Sharp Services, LLC is seeking a Validation Engineer I for Allentown, PA. The role supports validation programs across Sharp facilities, including packaging, HVAC, and equipment qualification, ensuring cGMP compliance and timely project delivery.

You will write IQ/OQ/PQ/PV protocols, participate in URS, FAT, SAT, and engineering studies, and coordinate validation activities with internal teams and customers. Strong documentation and communication skills are essential.