Philadelphia, PA
Job Summary
The Director of Engineering will be responsible for the engineering, commissioning, equipment validation, 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, etc.) 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 environment
Prepare and propose the annual Engineering and Maintenance budget, by defining the allocation of resources necessary for the development of the activity, as well as ensuring the monitoring and control of its evolution, identifying any deviations between the real and the foreseen 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 whilst maximizing productivity.
Appraise team performance, coaching team members to elevate their performance through development plans and address poor performance through improvement plans together with 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 design and operate within Regulatory, Nationals 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
401k with a highly competitive match
Generous PTO, including floating holidays
Career growth and internal opportunities
Tuition reimbursement
Relocation assistance
Performance-based bonus
Employee Recognition Programs
TO APPLY - Please forward resume to Amanda Sonus at asonus@pailingroup.com
pailingroup.com
