Position SummaryWe are seeking a highly motivated
Senior Engineer to provide technical expertise and leadership in support of equipment assessments and engineering evaluations within a regulated pharmaceutical or biotechnology manufacturing environment. This role is responsible for conducting comprehensive technical assessments, evaluating equipment performance and reliability, supporting quality systems activities, and ensuring equipment remains fit for its intended use while maintaining compliance with cGMP requirements.
Key Responsibilities- Perform technical assessments of manufacturing equipment to evaluate performance, reliability, operational suitability, and continued fitness for intended use.
- Prepare, review, and approve technical reports, engineering assessments, equipment evaluations, technical justifications, and supporting documentation.
- Evaluate equipment failures, recurring performance issues, maintenance history, operating conditions, and their potential impact on product quality, process performance, equipment qualified state, and regulatory compliance.
- Provide engineering support for deviations, investigations, Corrective and Preventive Actions (CAPAs), change controls, risk assessments, and post-FDA commitment activities.
- Assess equipment design, functionality, lifecycle documentation, maintenance strategies, and long-term reliability to support informed technical decision-making.
- Review and interpret engineering drawings, technical specifications, vendor documentation, equipment manuals, work orders, calibration records, maintenance records, and historical performance data.
- Develop scientifically sound, data-driven conclusions and recommendations supported by objective evidence and documented rationale.
- Collaborate effectively with Manufacturing, Maintenance, Automation, Validation, Quality Assurance, Process Development, and external vendors to gather, analyze, and evaluate technical information.
- Ensure technical assessments are complete, traceable, inspection-ready, and compliant with applicable regulatory and internal quality requirements.
- Support continuous improvement initiatives to enhance equipment reliability, operational performance, and compliance.
- Maintain a strong field presence by inspecting equipment, verifying actual operating conditions, and confirming technical observations within manufacturing areas.
- Independently manage multiple assessments, priorities, and deliverables while meeting project timelines and quality expectations.
- Experience supporting purification, fermentation, process equipment, utilities, or pharmaceutical manufacturing systems is preferred.
Qualifications- Bachelor's Degree in Engineering or related technical discipline.
- Minimum of 4 years of engineering experience in the pharmaceutical, biotechnology, or other regulated manufacturing industry.
- Experience performing technical assessments of manufacturing equipment in a regulated environment.
- Strong understanding of cGMP regulations and quality system requirements.
- Excellent technical writing, communication, and problem-solving skills.
