Job Description:

The Process Quality Engineer is responsible for supporting Quality Assurance monitoring of manufacturing processes, materials, utilities, and related environmental controls within the manufacturing operations. This role ensures compliance with GMP regulations, investigates deviations, and maintains high standards for product & process quality. Strong technical expertise and a commitment to continuous improvement within a regulated environment are required.

Responsibilities:

• Lead and execute deviation investigations, root cause analyses, product risk assessments, and corrective/preventive actions.
• Analyze manufacturing trends, unplanned maintenance, and environmental controls (HVAC and related systems) using statistical tools to ensure a continuous state of quality.
• Function as technical expert for quality initiatives and continuous improvement in one or more of the following areas:

• Cleanroom Facilities
• Drug Product Formulation: Solutions and Suspensions
• Blow-Fill-Seal (BFS) Manufacturing
• Pharmaceutical Packaging

• Collaborate with cross-functional teams in Operations, Development, Compliance, and Validation to ensure compliance of processes with GMP and company standards.
• Support new process development, change management, and risk management.
• Create and revise department documents (procedures etc.) and coordinate equipment calibration within department.
• Support regulatory inspections, audits, and batch related process quality inquiries.

Qualifications:

• Four-year college degree in Engineering
• Proficiency with statistical analysis tools and software packages
• Strong technical writing, documentation, and communication skills
• Strong leadership skills
• Familiarity of AQL, Six Sigma, Kaizen, and/or other Quality Improvement tools
• Experience in the Pharmaceutical or regulatory environment and knowledge of GMP, ICH, FDA, and EMA preferred