Lead Cleaning Validation Engineer

RXinsider LTD.; Columbus (OH); On-site; USD 110,000 - 140,000; Full time

Benefits offered by this job

Annual performance bonus

401(k) matching

20 days PTO

Personal days

Holidays

Job summary

Hikma Pharmaceuticals USA Inc. is seeking a Sr. Engineer, Cleaning Validation in Columbus, OH to lead validation deliverables and ensure compliance with regulatory standards across the cleaning lifecycle.

You will develop, review, and approve cleaning validation procedures, support training, and collaborate with cross-functional teams to maintain validated states and drive continuous improvements in cleaning processes.

Qualifications

• Bachelor’s degree in engineering or related scientific discipline.
• Minimum of eight (8) years of pharmaceutical industry experience in quality, production, engineering or a laboratory setting.
• 5+ years cleaning validation experience in a pharmaceutical environment.
• Experience with authoring and execution of Quality documentation and validation reports.
• Knowledge of FDA cGMP, ISPE’s Risk-Based Manufacture of P Pharmaceutical Products and ICH Q9.

Responsibilities

• Develops and approves validation deliverables compliant with regulations and business requirements.
• Periodic reviews of cleaning processes for validated state effectiveness.
• Revise and approve cleaning procedures and related work instructions.
• Support optimization and improvements of cleaning processes for consistency and effectiveness.
• Lead training to ensure compliance and process effectiveness.
• Create policies, procedures, guidelines, and templates for validation.
• Mentor Cleaning Validation colleagues on policies and procedures.

Skills

Quality documentation

FDA cGMP knowledge

Data analysis

Project management

Interpersonal communications

Regulatory inspections experience

Quality risk management (ICH Q9)

Education

Bachelor’s degree in engineering

Tools

Change control system

SAP

Document Management system

Laboratory information system

Job description

Hikma Pharmaceuticals USA Inc. is seeking a Sr. Engineer, Cleaning Validation in Columbus, OH to lead validation deliverables and ensure compliance with regulatory standards across the cleaning lifecycle.

You will develop, review, and approve cleaning validation procedures, support training, and collaborate with cross-functional teams to maintain validated states and drive continuous improvements in cleaning processes.