Engineer Engineering Compliance

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 facility and engineering GMP compliance investigations including facility services, maintenance, utilities, and processing engineering aspects, ensure key performance indicator met targeted metric. The activities include management review, validation, change control and CAPA and ensure that engineering systems are managed in compliance with cGMP expectations. - Lead deviation triage, discussions and investigations for F&E with the support of Functional Area Owners and other SME. Serve as F&E SME for cross functional RCA investigations. - Own and manage on time closure of F&E DQMS records (NCs, CAPAs and Change Control). - Participate in and coordinate engineering team regulatory Inspection readiness GEMBA Walkdowns and pressure tests preparation for respective F&ESMEs. - Represent department for site Inspection Readiness meetings, and as auditee for ASM internal audits. - Lead and support F&E Triage team for all regulatory inspections, handling all inspection requests, preparing responses, and advising Subject Message Experts on response strategy. Qualifications & Expectations: - 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 6 years of directly related experience OR High school diploma in Science or Engineering/GED and 8 years of directly related experience. - Preferred 5+ years of relevant work experience in the commercial manufacturing environment within the pharmaceutical/biologics industry. - Related work experience (Quality Assurance, Engineering, manufacturing or 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. - Ability to work independently and collaboratively. - Good understanding in customer's voice and quality requirements is a must. - Strong team player, able to effectively work within and across teams. - Strong interpersonal skills and verbal/written communication; ability to distil complex information into simple and clear messages. - Ability to prioritize and multitask to enhance productivity and manage workload in a fast-paced, rapidly changing environment. - Demonstrates critical, creative thinking and problem-solving skills. - Strong customer-oriented personalities. - Ability to tactfully negotiate and positively influence peers is an added advantage.