Validation Engineer I: Process & Equipment Validation

Sharp Services; Allentown (Lehigh County); On-site; USD 90,000 - 110,000; Full time

Job summary

Sharp Services seeks a Validation Engineer I to lead validation activities at a designated site in the Allentown area. Responsibilities include writing ES/IQ/OQ/PQ protocols, supporting URS, FAT, SAT, and coordinating packaging, HVAC, and facilities qualification under cGMP guidelines.

The role involves communicating validation requirements to customers, reviewing protocols, and supporting internal audits. A BS/BA in a technical field with 3–5 years experience is preferred, with ASQ

Qualifications

• Bachelor’s degree in technical discipline (BS/BA) from a four-year college or university preferred with three to five years related experience and or training; or equivalent combination of education and experience.
• Independent certification of advanced quality skills and practices (i.e. ASQ, CQE, Six Sigma, etc.) is required
• Knowledge of current validation principles and industry practices, including FDA regulations, cGMPs, and validation guidance documents is required.
• Knowledge of basic engineering principles and practices, equipment automation controls, etc. is required.
• Ability to structure validation protocols in conformance with a planned validation approach is required.
• Familiarity with quality and attribute sampling plans (e.g. ANSI ZI.4) is required.
• Excellent written communication skills are required.
• Ability to plan and schedule validation activities and to multi-task is required.
• Good oral communication, organizational and planning skills are required.
• Familiarity with quality engineering practices in packaging operations is desired.
• Relevant ASQ certification is desired.

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 within the guidelines of cGMP.
• Participate in URS, FAT, SAT and Engineering Studies when requested.
• Write PV protocols specific to customer needs and per Sharp requirements.
• Responsible for communicating validation approach and requirements with customers.
• Execute validation protocols.
• Review executed protocols and write summary reports.
• Provide support for customer audits and external regulatory audits specific to validation activity at all Sharp facilities at the direction of the Validation Manager.
• Responsible for coordinating the execution of validation activities at designated Sharp facility including but not limited to packaging, HVAC, equipment qualification, packaging processes and facilities and utilities.

Skills

Written communication

Oral communication

Planning & scheduling

Multi-tasking

Independent work

Education

Bachelor’s degree in technical discipline

ASQ CQE or Six Sigma certification

Job description

Sharp Services seeks a Validation Engineer I to lead validation activities at a designated site in the Allentown area. Responsibilities include writing ES/IQ/OQ/PQ protocols, supporting URS, FAT, SAT, and coordinating packaging, HVAC, and facilities qualification under cGMP guidelines.

The role involves communicating validation requirements to customers, reviewing protocols, and supporting internal audits. A BS/BA in a technical field with 3–5 years experience is preferred, with ASQ