About the role
Job Responsibilities:
Responsibilities include but are not limited to:Process Optimization & Manufacturing Support
* Provide day-to-day engineering support to pharmaceutical manufacturing operations. * Analyze manufacturing processes to identify opportunities for improving efficiency, quality, yield, and cost. * Troubleshoot process issues and implement corrective and preventive actions (CAPAs). * Monitor process performance through data analysis and key performance indicators (KPIs). * Lead root cause investigations related to process deviations, nonconformances, and customer complaints.Validation & Compliance
* Support process validation, equipment qualification, and revalidation activities. * Develop and execute validation protocols, reports, and technical documentation. * Ensure compliance with FDA regulations, cGMP requirements, BD policies, and applicable quality standards. * Support internal and external audits, inspections, and regulatory commitments. * Maintain manufacturing documentation, standard operating procedures (SOPs), and work instructions.Continuous Improvement
* Lead Lean Manufacturing and Continuous Improvement projects. * Utilize Six Sigma, DMAIC, and problem-solving methodologies to eliminate waste and improve process capability. * Identify and implement productivity, quality, and cost-reduction initiatives. * Participate in site transformation and operational excellence programs.Project Management
* Support new product introductions, technology transfers, and process changes. * Coordinate engineering projects from conception through implementation. * Manage timelines, risk assessments, resource requirements, and project documentation. * Collaborate with Maintenance, Quality, Operations, Validation, Regulatory Affairs, and Supply Chain teams.Safety & Quality
* Promote a strong culture of safety, compliance, and quality. * Support risk assessments, process hazard evaluations, and quality improvement initiatives. * Ensure all engineering activities are performed following EHS and Quality Management System requirements.Education and Experience:
* Bachelor’s degree in Chemical Engineering, Industrial Engineering, Mechanical Engineering, Biomedical * 3+ years of experience of engineering experience within a pharmaceutical, medical device, biotechnology, or highly regulated manufacturing environment * Experience working in FDA-regulated, cGMP, validation, and quality systems. * Experience in pharmaceutical manufacturing and aseptic or sterilization processes preferred. * Knowledge of process validation, equipment qualification (IQ/OQ/PQ), and risk management methodologies, preferred. * Lean Six Sigma Green Belt or Black Belt certification preferred. * Experience with SAP, TrackWise, MES, or other manufacturing systems preferred. * Knowledge of statistical tools and process capability analysis. * Bilingual (English/Spanish) preferred.Knowledge and Skills:
Technical Skills * Strong analytical and problem-solving skills. * Experience conducting root cause investigations and implementing CAPAs. * Proficiency in Microsoft Office applications and data analysis tools.Key Competencies
* Strong problem-solving and analytical skills * Detail-oriented with data-driven decision making * Ability to manage problem solving and critical thinking * Effective communication and collaboration across all levelsPhysical Demands:
* Manufacturing environment with exposure to production areas.Work Environment:
* Manufacturing