The Interface Engineer will act as a critical liaison between the client team and the Global Facility Delivery (GFD) group in a highly regulated biopharmaceutical environment. The successful candidate will be responsible for orchestrating effective communication, ensuring rigorous compliance with all quality and Health & Safety (H&S) policies, and facilitating the seamless delivery of projects. This role demands a detail-oriented professional who can balance technical acumen with exceptional organizational and stakeholder management skills.
Key Responsibilities
* Facilitate Communication: Serve as the primary point of contact between client stakeholders and the GFD team, ensuring all expectations, updates, and requirements are clearly communicated and documented.
* Meeting Coordination: Schedule, organize, and lead regular meetings (both virtual and on-site) to drive project progress, capture action items, and ensure alignment across teams.
* Change Control Management: Initiate, coordinate, and track change control processes in accordance with internal and regulatory requirements. Ensure all change controls are properly documented, assessed for impact, and executed with stakeholder buy-in.
* Document Review and Scheduling: Oversee the scheduling and execution of document reviews, ensuring timely completion and submission of technical, quality, and compliance documentation. Track document status and proactively follow up to mitigate delays.
* Quality Assurance: Maintain stringent adherence to all quality policies and procedures. Work closely with Quality Assurance (QA) teams to ensure project deliverables meet or exceed regulatory and internal standards.
* Health & Safety Compliance: Ensure comprehensive compliance with Health & Safety regulations and policies. Champion a safety-first culture in all project activities, including meetings, site visits, and documentation.
* Risk Management: Identify, assess, and escalate risks related to compliance, schedule, or project execution. Support the development of mitigation strategies in collaboration with relevant stakeholders.
* Continuous Improvement: Seek opportunities to enhance processes and workflows between the client and GFD, driving efficiency while maintaining compliance and quality standards.
Qualifications
* Bachelor’s degree in Engineering (Chemical, Mechanical, Electrical, or related field) or equivalent experience in the biopharmaceutical or pharmaceutical sector.
* Minimum of 3 years’ experience working in highly regulated environments, preferably in biopharmaceutical manufacturing or facility delivery.
* Proven experience managing change controls and working with document management systems in a GxP environment.
* Strong understanding of quality management systems (QMS), good manufacturing practice (GMP), and health & safety regulations relevant to biopharmaceutical operations.
* Excellent organizational, time management, and communication skills.
* Ability to build strong working relationships across multidisciplinary teams and with external stakeholders.
* Meticulous attention to detail and proactive approach to problem-solving.
* Proficiency with MS Office Suite, project management tools, and electronic documentation systems.
Key Attributes
* Collaboration: Demonstrates a diplomatic and inclusive approach to engaging stakeholders from diverse functional backgrounds.
* Accountability: Takes ownership for meeting schedules, documentation deadlines, and compliance obligations.
* Adaptability: Comfortable managing competing priorities and adapting to rapidly changing project demands.
* Integrity: Upholds the highest standards of honesty, confidentiality, and regulatory compliance.
* Initiative: Proactively identifies and addresses potential gaps in communication, documentation, or compliance.
Meeting Management
* Create and circulate meeting agendas, minutes, and action logs to ensure transparency and follow-through.
* Ensure all meetings are documented in alignment with company and regulatory requirements.
Change Control Administration
* Guide stakeholders through the change control process to ensure robust impact assessments and timely approvals.
* Maintain change control records in the designated electronic system.
Document Review Oversight
* Coordinate the review of SOPs, validation documentation, technical drawings, and other critical records.
* Track version histories and ensure records are archived appropriately.
Compliance & Auditing
* Support internal and external audits as required, providing documentation and explanations pertaining to interface activities.
* Stay current with regulatory changes and best practices impacting project delivery and compliance.
Health & Safety Leadership
* Participate in risk assessments, safety walks, and incident investigations as assigned.
* Promote compliance with PPE, safe work procedures, and reporting of near-misses or hazards.
Application Process
Interested candidates are invited to submit a CV and cover letter detailing relevant experience, technical qualifications, and examples of ensuring project compliance and stakeholder engagement within a regulated environment.
Job Type: Full time, Contract 12-24 months
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