Sobre este puesto de Process Engineer - Pharma en BD
We are the people who give possibilities purpose
BD is one of the largest global medical technology companies in the world. Advancing the world of health™ is our Purpose, and it’s no small feat. It takes the imagination and passion of all of us—from design and engineering to the manufacturing and marketing of our billions of MedTech products per year—to look at the impossible and find transformative solutions that turn dreams into possibilities.
Job Description
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 levels
Physical Demands:
Manufacturing environment with exposure to production areas.
Work Environment:
Manufacturing
Why Join Us?
To find purpose in the possibilities, we need people who can see the bigger picture, who understand the human story that underpins everything we do. We welcome people with the imagination and drive to help us reinvent the future of healthcare. At BD, you’ll discover a culture in which you can learn, grow and thrive.
We believe that when people connect in person, we learn faster, collaborate more deeply, and build a stronger culture. Join us and enjoy a culture where face-to-face collaboration supports your learning, your progress, and your success.
To learn more about BD visit https://bd.com/careers.
Becton, Dickinson, and Company is an Equal Opportunity Employer. We evaluate applicants without regard to race, color, religion, age, sex, creed, national origin, ancestry, citizenship status, marital or domestic or civil union status, familial status, affectional or sexual orientation, gender identity or expression, genetics, disability, military eligibility or veteran status, and other legally protected characteristics.
Required Skills
Optional Skills
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