| Location | Raritan, NJ |
Responsibilities: for the (CQV) Commission Qualification 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. · 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. · Assist with the development and implementation of standard operating procedures related to equipment validation and qualification. · Stay up-to-date with industry trends and regulations related to equipment validation and qualification. Qualifications: for the (CQV) Commission Qualification Validation Engineer include: · Bachelor's degree in Engineering or a related field. · Minimum of 5+ years of experience in equipment commissioning and 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 (CQV) Commission Qualification Validation Engineer include: · Compensation Range is dependent upon experience · Comprehensive benefits package