Process Engineer

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 levels

Physical Demands

• Manufacturing environment with exposure to production areas.

Work Environment

• Manufacturing