Manufacturing Process and Compliance Engineer

include :

• Lead and document investigations related to manufacturing deviations, non-conformances, out-of-specification (OOS) events, and quality issues to determine root cause and assess product impact.
• Develop, implement, and track CAPAs to ensure timely and effective resolution of quality and compliance issues.
• Author, revise, review, and approve manufacturing Standard Operating Procedures (SOPs), work instructions, batch records, and other controlled documents to maintain compliance and operational effectiveness.
• Collaborate with cross-functional teams including Manufacturing, Quality Assurance, Quality Control, Engineering, Validation, and Supply Chain to resolve production and compliance-related issues.
• Support internal and external audits, regulatory inspections, and compliance assessments by providing technical expertise and documentation.
• Perform root cause analysis using structured problem-solving methodologies such as 5 Whys, Fishbone Diagrams, and Failure Mode and Effects Analysis (FMEA).
• Monitor manufacturing processes and quality metrics to identify trends, risks, and opportunities for improvement.
• Lead and support continuous improvement projects focused on process optimization, waste reduction, cycle-time improvement, and operational efficiency.
• Evaluate proposed process changes through change control systems and assess potential impacts on product quality, regulatory compliance, and manufacturing performance.
• Ensure compliance with current Good Manufacturing Practices (cGMP), company policies, and applicable regulatory requirements.
• Participate in risk assessments, process validations, and implementation of corrective actions resulting from audit findings or quality events.