Validation Engineer

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