Senior Validation Engineer - CQV Leader (GMP/FDA)

Sharp Clinical Services; Macungie (Lehigh County); In loco; USD 95.000 - 125.000; Tempo pieno

Descrizione del lavoro

Sharp Clinical Services in the United States is seeking a Validation Specialist to plan, coordinate and execute validation activities for equipment, processes, facilities, and computer systems across designated sites. You will develop IQ/OQ/PQ protocols, supervise field validation, and support internal teams while coordinating with QA, Operations, Sales and customers.

Travel between Sharp sites and off-site assignments is possible.

Competenze

• Bachelor’s degree in a technical discipline from a four-year college; 6–10 years related experience.
• Independent certification in quality practices (ASQ CQE or Six Sigma) required.
• Knowledge of FDA regulations, cGMPs and validation guidance.
• Excellent written and verbal communication skills.
• Ability to plan, schedule and manage validation activities.

Mansioni

• 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 Sharp Master production Records.
• Develop validation requirements for projects related to new equipment, processes, facilities, and products.
• 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 packaging, cleaning, HVAC and computer system.
• Write PV protocols specific to customer needs.
• Communicate validation approach and requirements with customers.
• Monitor or execute validation protocols assigned.
• Review executed protocols and write final reports.
• Participate in customer audits specific to validation activity at all Sharp facilities.
• Participate in external regulatory audits specific to validation activities at the direction of the Validation Manager.

Conoscenze

Independent cert. in quality

Quality engineering practices

Written and verbal communication

Project planning & scheduling

DOE and statistics

Formazione

Bachelor's degree in technical discipline

Advanced quality certifications (ASQ CQE / Six Sigma)

Strumenti

Microsoft Office Suite

Pilgrim SmartSolve

Lotus Notes

Descrizione del lavoro

Sharp Clinical Services in the United States is seeking a Validation Specialist to plan, coordinate and execute validation activities for equipment, processes, facilities, and computer systems across designated sites. You will develop IQ/OQ/PQ protocols, supervise field validation, and support internal teams while coordinating with QA, Operations, Sales and customers.

Travel between Sharp sites and off-site assignments is possible.