Corporate Director of Engineering

Engineering Philadelphia, Pennsylvania


Description

Corporate Director of Engineering

This position directs the maintenance and engineering site heads at all Lannett finished dose manufacturing and corporate locations. The position develops and maintains corporate maintenance and engineering standards, monitors LCI capital spending against budget, develops and leverages site engineering specialties across all sites, and provides direct oversight for the highest value capital projects.

This position reports to the Vice President and has an ongoing relationship with them. This position must interface with the site Directors of Operations, Vice President of Pharmaceutical Development, the Senior Director of Technical Services, the Vice President of Quality Assurance, and their respective staffs. The position also has an ongoing regular relationship with the members of the EHS and Information Technology Departments. The position also works with management of Cody Labs on an as needed basis.

 

Responsibilities:

  • Directing the development and implementation of engineering and maintenance standards – Corporate Standards - to comply with all FDA, EMEA, and SFDA regulations.
  • Ensure each sites develops and maintains standard operating procedures and policies compliant with corporate standards.
  • Complying with cGMP standards and practices as it relates to operations, equipment, and facilities.
  • Track and manage site adherence to capital budgets.
  • Assists in the development of operating and capital budgets for the Maintenance and Engineering departments at all sites
  • Approves and tracks all capital projects across the entire network.
  • Drives facility cost reductions initiatives at all sites.
  • Developing realistic budgets and managing costs and operating within the established budget requirements.
  • Maintain project timelines.
  • Provide direct oversite for the development, execution, and completion of all major, high value, LCI capital projects.
  • Confirming projects are completed on time and on budget, and meet end user and company expectations.
  • Provide stewardship for the corporate network strategy.
  • Maintains corporate metrics through the review of site metrics.
  • Participates as needed in site project meetings and periodically performs facility inspections and audits
  • Reviews site Corrective Action plans
  • Complying with established company policies and procedures.
  • Keeping current on information and technology affecting the subordinate functional areas to increase innovation and ensure compliance.
  • The content, quality, and accuracy of records, reports, analysis, and documents prepared for both internal and external distribution.

 

  • Manage the Engineering and Maintenance site heads.
  • Assess engineering resources within the LCI network to share unique skill resources across the sites as needed.
  • Develops retention and succession plans for the responsible groups.
  • The performance and development of a professional staff, and the retention, direction, and engagement of that staff to meet immediate and future business

needs.

 

 

Requirements:

  • Bachelor’s degree required.  Masters preferred
  • Minimum 10 years’ experience in engineering/engineering management, preferably in a pharmaceutical/FDA-regulated work environment.
  • 5 or more years’ experience leading others on project teams, interfacing and influencing at executive levels.

 

 

  • Substantial operational engineering experience.
  • Full understanding of pharmaceutical supply chain.
  • Knowledge of Quality Assurance (QA) and Environmental, Health & Safety (EHS) standards.
  • Experience working on regulatory standards:  FDA, Good Engineering Practice (GEP), Good Manufacturing Procedures (GMP) and Good Documentation Procedures (GDP).
  • Experienced working on all aspects of capital projects, including budgeting, design, construction, validation, startup and ongoing operations.
  • Proven leadership skills

 

 

  • Ability to stand for up to 10 hours per day.
  • Frequent sitting, standing, walking, reading of written documents and use of computer monitor screen, writing, talking, and listening.
  • Occasional stooping, kneeling, crouching, bending, carrying, reaching with hands and arms.
  • Occasional lifting and/or moving up to 30 pounds.
  • Business Travel up to 25% of time.