Senior Validation Engineer — CGMP, QA & Audits

Sharp Services, LLC; Macungie (Lehigh County); On-site; USD 90,000 - 130,000; Full time

Job summary

Sharp Services, LLC is seeking a Validation Specialist to independently plan, coordinate, and execute validation activities across equipment, processes, facilities, and computer systems. The role involves collaboration with Operations, Sales, Engineering, Quality Assurance, and customers to schedule and perform validation per cGMP guidelines.

Location includes Conshohocken and Allentown facilities, with duties at designated sites.

Qualifications

• Bachelor’s degree in technical discipline (BS/BA) from a four‑year college or university preferred with six to ten years related experience and/or training.
• Independent certification of advanced quality skills and practices (i.e. ASQ, CQE, Six Sigma, etc.) is required.
• Board knowledge of current validation principles and industry practices, including FDA regulations, cGMPs, and validation guidance documents is required.

Responsibilities

• Support the Validation Manager in developing validation approach, design and execution.
• Represent the Validation function in the review and approval of Change Controls involving equipment and processes.
• Complete the Validation review and approval of Master production Records.
• Write IQ/OQ/PQ protocols for appropriate equipment and systems within the guidelines of cGMP.
• Supervise the execution of validation activities at designated Sharp facility including but not limited to packaging, cleaning, HVAC and computer system.
• Participate in customer audits specific to validation activity at all Sharp facilities as directed by the Validation Manager.

Skills

Independent planning

Scheduling

Problem solving

Documentation writing

Education

BS/BA in technical discipline

ASQ CQE Six Sigma certs

Tools

Pilgrim SmartSolve

Lotus Notes

Microsoft Office

Job description

Sharp Services, LLC is seeking a Validation Specialist to independently plan, coordinate, and execute validation activities across equipment, processes, facilities, and computer systems. The role involves collaboration with Operations, Sales, Engineering, Quality Assurance, and customers to schedule and perform validation per cGMP guidelines.

Location includes Conshohocken and Allentown facilities, with duties at designated sites.