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Hovione

Hovione is an international company with over 55 years’ experience in the development and compliant manufacture of Active Pharmaceutical Ingredients and Drug Product Intermediates. With four FDA inspected sites in Portugal, the U.S., Ireland and China, Hovione offers integrated API, particle design, formulation development and GMP manufacturing. In the inhalation area, Hovione is the only independent company offering such a broad range of services.

To reinforce our team we are looking to fill the following position at our New Jersey site:



Head of Maintenance and Engineering  (US)

The mission for the Head of Engineering will be to maintain the facility areas including production areas, laboratories, office area, outside areas and equipment systems, in good status, efficient and maintained at a minimum cost and minimum downtime while ensuring all facility-related activities are carried out in compliance with all Federal, State and Local requirements. Main job objectives include managing all facility engineering activities related with maintenance and capital improvement projects for new or upgrade of existing equipment/facilities, managing engineering projects as per approved scope and timeline following Good Engineering Practices, and managing the technical qualification of engineering projects. Also, to maintain key performance indicators for facility-related safety incidents/recordable, maintenance spending and utility usage/spending.

Main responsibilities:

  • Purpose investment, headcount and opex budget for the engineering area;
  • Manage SAP Plant Maintenance, Preventive Maintenance and Instrumentation Calibration Programs for all GMP and non-GMP equipment systems that include the internal and external;
  • Manage maintenance contracts with 3rd-parties in coordination with the Indirect Materials Purchasing team;
  • Coordinate facility-related change controls for changes to any GMP or HSE equipment system;
  • Coordinate events in CAPA system related to systems with GMP or HSE impact;
  • Manage training of engineering team members or other facility related training sessions as per approved training plans;
  • Ensure that Engineering team follows all HSE permits for Hot Work, Lock-Out/Tag-Out, Hazardous work, Roof Access and confined space. Ensure participation of all direct reports in required EHS training;
  • Manage all facility-related internal procedures and qualification protocols;
  • Actively assist the Compliance Department during internal, customer and FDA audit reviews;
  • Maintain open communication with team members concerning EHS including documentation of incidents or recordables;
  • Recommend cost reduction programs related to 3rd-party service contracts and utility services;
  • Develop cost estimates, requests, and execute capital expenditures for the facility;
  • Establish and maintain strong engineering team spirit;
  • Develop and manage the Engineering operating budget;
  • Ensure activities meet GMPs as per Hovione's quality system;
  • Maintain an open-door policy for everyone to share views and opinions;
  • Implement professional development plans for all direct reports in order to have likely successors;
  • Identify growth opportunities and challenges to help individuals achieve their professional potential

Profile:

  • A BS in Mechanical, Chemical, Industrial or other facilities related Engineering degree;
  • Minimum of 10 years experience in either a chemical or pharmaceutical facility managing and executing all aspects of the facility maintenance or project engineering;
  • Must have a basic understanding of Good Manufacturing Practices (GMPs) as per ICH Q7 or 21CFR part 210/211;
  • Business training (MBA or Master degree) and previous management experience;
  • Possesses good leadership, team management, and communication skills
  • Fluent in English and able to communicate at all levels;
  • Experience with SAP;
  • Results driven;
  • Having international experience is a plus;
  • Pragmatic, resilient, proactive, creative, innovative and with high ethical standards.
         

We offer:

  • Competitve salary and benefits commensurate with the job function and candidate’s relevant experience;
  • Excellent work environment, with a strong focus on quality.