Director of Engineering

Job Summary The Director of Engineering will be responsible for the engineering, commissioning, equipment validation, and maintenance functions at the Philadelphia, Pennsylvania manufacturing, Packaging, and R&D facility. In addition, the Director of Engineering will be responsible for capital project delivery. This role will require onsite presence in Philadelphia, Pennsylvania. The Director will report to the Operations Site Lead. Responsibilities And Learning Opportunities Oversee the engineering, CQV, maintenance, and metrology teams, including mentorship, development, and partnering with HR to effectively hire and onboard. Management of site capital projects, inclusive of a new facility capital project. Establish the maintenance and calibration programs, inclusive of implementation of software systems and necessary vendor relationships. Lead process equipment, QC equipment, utility system, and equipment validation. Own validation and qualification protocols and support SOPs. Ensuring all cGMP and non‑cGMP systems and areas are properly maintained and operate robustly. Partner with other leadership cross‑functionally (e.g., Regulatory, Quality, Manufacturing, Development) to achieve overall organizational objectives and proactively address project delivery challenges. Lead Engineering and Maintenance FDA inspection readiness. Manage the roles and workflows of the Engineering and Maintenance functions; devise and coordinate working relationships between Engineering and other areas. Establish effective organizational structures, anticipating or adapting to changing environments. Prepare and propose the annual Engineering and Maintenance budget, by defining the allocation of resources necessary for the development of the activity, and ensuring the monitoring and control of its evolution, identifying any deviations between the real and the forecast and taking corrective measures. Ensure all team members are aligned and motivated towards achieving department goals, and company values and culture by promoting their personal and professional development while maximizing productivity. Appraise team performance, coaching team members to elevate their performance through development plans, and address poor performance through improvement plans together with the HR business partner. Identify and develop talent to guarantee future performance and area growth; ensure that team members assigned to areas are trained in the required technical and behavioral competencies. Identify and promote systems and procedures that will benefit the global organization. Define strategies and standards, aiming for CAPEX and OPEX optimization and knowledge management, to enable productivity, quality, cost competitiveness and safety. Provide technical solutions for challenges during the life cycle of installations without compromising the design purpose and the process functionality, quality and safety. Select reliable and competent partner companies capable to support the life cycle of our facilities and equipment and our growth plans. Ensure that continuous improvement and lean thinking is used in all departmental activities. Liaise with authorities to guarantee timely approvals of submissions, ensuring that facilities are designed and operate within regulatory, national laws, and health authority requirements. Ensure compliance with GMP, internal and external requirements as well as promote the implementation and maintenance of the organization’s policies, systems, and procedures. Requirements B.S. in Chemical or Mechanical Engineering required; advanced experience in managing industrial projects, preferably in Chemical or Pharma companies. Experience managing and developing teams. Extensive experience in project management and execution. Extensive knowledge of quality requirements applicable to technical installations, as well as legislation applicable to engineering projects. Skilled at driving processes and tools. Fluent in written and verbal English is a requirement. Experience participating in FDA/EMA/PMDA inspections and internal audits preferred. Experience with cGMP facility design, commissioning, validation, and qualification. Benefits Medical/dental/vision/life – low employee premiums. 401(k) with a highly competitive match. Generous PTO, including floating holidays. Career growth and internal opportunities. Relocation assistance. Performance-based bonus. Employee Recognition Programs.

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Please forward resume to Amanda Sonus at View email address on click.appcast.io. #J-18808-Ljbffr Pailin Group Psc