Career Category

Job Description

The Engineering Compliance Engineer is responsible for Engineering Compliance and serve as interface with site Quality Assurance team providing Quality oversight to Engineering team, provides support of complex engineering investigations, change control, and unexpected result investigations.

Responsibilities

• Provide Engineering Compliance oversight and serve as interface with site Quality Assurance team providing Quality oversight to Engineering team, ensuring appropriate application and execution of GMP compliance requirements.
• Serve as liaison with site Quality Assurance team to support complex engineering GMP compliance investigations including maintenance, utilities, and processing engineering aspects, ensure key performance indicator met targeted metric. The activities including management review, validation, change control and CAPA and ensure that engineering systems are managed in compliance with cGMP expectations
• Providing oversight on Engineering validation activities through phases of engineering project commissioning, qualification, process qualification, regulatory approval.
• Participate and coordinate engineering team regulatory Inspection readiness GEMBA Walkdowns and pressure tests preparation for respective F&E SMEs.

• Manage on time closure of F&E TrackWise records (NCs, CAPAs and Change Control).
• F&E Primary Contact for Data Integrity Audit and meetings.
• Support Quality issues during commissioning and validation activities.
• Prioritize and track completion of F&E Gap assessments per OS revision.
• Supports F&E SMEs on the review for revision of SOPs.

Basic Qualifications

• Master’s degree in Science, Chemical, Process or Mechanical Engineering OR
• Bachelor’s degree in Science or Engineering and 2 years of directly related experience OR
• Associate degree in Science or Engineering and/or 6 years of directly related experience OR
• High school diploma in Science or Engineering / GED and 8 years of directly related experience

Preferred Qualifications

• 5+ years of relevant work experience in the commercial manufacturing environment within the pharmaceutical / biologics industry
• Related work experience (Quality Assurance, Engineering, manufacturing ot process development) in the pharmaceutical/biopharmaceutical industry with progressively increasing responsibility
• Experience in providing investigations to support cGMP production
• Good communication skills (technical writing and verbal communication/presentation)
• Interacts effectively with variety of communication and working styles
• Experience with regulatory audits and inspections
• Problem solving skills with the ability to apply logic and assess data to reach decisions and solutions related to compliance and product quality Experience managing contractors and vendors

Fluency in English, in both oral and written communications