Seeking a Senior Process Engineer with strong experience in pharmaceutical or combination (drug-device) manufacturing. Must have hands-on expertise in PFMEA and process validation within regulated environments.
Key Responsibilities
Lead process development, optimization, and scale-up
Develop and maintain PFMEA and risk management documentation
Support process validation (IQ/OQ/PQ)
Drive root cause analysis, CAPA, and continuous improvement
Collaborate with Quality, R&D, and Manufacturing teams
Ensure compliance with cGMP, FDA, and ISO standards
Requirements
8+ years in pharma or combination products
Strong PFMEA experience (mandatory)
Experience with process validation and GMP environments
Knowledge of FDA regulations and ISO 13485
Good analytical and communication skills