Piper Companies is currently looking for an experienced Validation Engineer to in Silver Spring, MD, to work for an innovative and growing pharmaceutical organization.
Responsibilities for the Validation Engineer include:
• Assist with the development of equipment validation protocols (IQ/OQ/PQ) for new instruments and ensure compliance with applicable regulations and guidelines.
• Responsible for supporting the qualification of equipment, facilities, and utilities to ensure compliance with current Good Manufacturing Practices (cGMP) and the company's quality standards
• This role involves executing qualification protocols, identifying deviations, and collaborating with various teams to ensure successful equipment installation and validation processes
• Assist in the preparation and execution of Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ) protocols for equipment, facilities, and utilities
• Conduct equipment validation testing and generate validation reports.
• Provide technical support to manufacturing personnel and troubleshoot any issues related to equipment performance or quality.
• Collaborate with cross-functional teams to ensure timely completion of validation activities.
• Participate in risk assessments and provide recommendations for risk mitigation.
Qualifications for the Validation Engineer include:
• Bachelor's degree in engineering or a related field.
• Minimum of 3-5 years of experience in equipment validation in a pharmaceutical or medical device manufacturing environment.
• Strong knowledge of applicable regulations and guidelines related to equipment validation (e.g., FDA, EU, ICH).
• Experience with IQ/OQ/PQ protocols, process validation, and risk assessment.
• Excellent problem-solving skills and attention to detail.
• Strong communication and interpersonal skills.
• Ability to work independently and as part of a cross-functional team
Compensation for the Validation Engineer include:
• Compensation Range is dependent upon experience
• Comprehensive benefits package
Keywords
GMP, Pharmaceutical Manufacturing, Equipment Qualification, Equipment Commissioning, Equipment Qualification, IQ/OQ/PQ, Comprehensive Benefits Package, Health, Vision, Dental #LI-ONSITE #LI-DF1
Piper Companies