Over de functie
Responsibilities include the following, while other duties may be assigned:
- Responsible for the direct supervision, performance, training, counseling and development of maintenance and engineering staff.
- Develop and oversees the planning, implementation, and documentation of projects that are intended to increase profitability, safety, or compliance, leading the group of project managers to ensure the site capital plan execution on time and quality, based on site´s priorities.
- Develop and oversees the maintenance and reliability programs, engineering, utilities operations and capital plan.
- As a key member of the Technical Services Leadership Team, the role will be expected to work with other site leaders in the execution of new business or any potential technical transfers or related projects. This will include providing technical oversight for these initiatives, supporting the site strategy and ensuring the entire engineering and maintenance department is fully aligned with Fagron corporate goals & objectives.
- Takes a tactical role on investigations and improvements partnering with operations, quality, supply, EH&S and other functions.
- Establishes short-term performance goals, monitors results and makes timely adjustments to achieve delivery objectives. Make his/her team accountable of the overall engineering and maintenance department performance and behaviors.
- Assures staff compliance with all procedures, current Good Manufacturing Practice regulations, and safety rules.
- Oversees the development and maintenance of a safe manufacturing environment by fostering compliance with regulatory, plant and corporate policies. Assures that appropriate corrective actions are taken to eliminate hazardous conditions.
- Helps to prepare, monitor and control site budget based on volume capacity, head count, and expenses.
- Promotes and emphasizes to all plant personnel adherence to safety practices and industry regulations. Considers impact of EPA, OSHA, & FDA on daily operations as well as proposed projects.
- Assures short and long-range coordination of activities with emphasis on efficient utilization of manpower and resources.
- Fosters a team atmosphere by encouraging employee suggestions and ideas for improvement, ensuring integration of the technicians’ workforce in investigations, projects, decision making, proposals, etc.
- Provide solutions to a wide range of difficult/complex problems which require the regular use of ingenuity, innovation, and creativity. May refer to precedents and policies. Able to gather, analyze and interpret information and identify cause and effect relationships. Solutions are imaginative, practical, thorough, and in line with organization objectives. Able to adapt and respond positively to situations and people in order to meet changing work unit priorities. Operates within established HR policies and basic colleague relations guidelines.
- An aptitude for understanding process technology and equipment, aseptic processing.
- Extensive knowledge in processes related to production of sterile dosage forms in pharmaceutical manufacturing. Specific knowledge of aseptically filled syringes and vials preferred. Knowledge of packaging operations and labeling systems.
- Aseptic Experience with knowledge of clean rooms, sterilizers – autoclaves, sterile filling, RABS, Isolators, sterilizing process, CIP & SIP (Clean In Place & Sterilize In Place) and critical systems for aseptic processing: Water For Injection (WFI), reverse osmosis water (RO), clean steam, HVAC.
Maak het verschil
You possess the following qualifications, background and abilities:
- A minimum of a Bachelor Degree in Engineering, or related discipline is required. Advanced degree is preferred.
- 5 to 10 years of direct experience in a pharmaceutical facility within engineering or management required.
- 3 to 5 years of supervisory experience. Managerial experience preferred.
- Development/process engineering experience preferred.
- Experience working with popular ERP systems (i.e. SAP, JDE, MAPICS, etc.) is required.
- Experience interpreting compliance requirements and regulations is required.
- This position may require up to 10% domestic and international travel including some overnights and weekends.
- Thorough knowledge of cGMP, safety and environmental regulatory requirements.
- Direct Experience in a parenteral facility will be desirable.
- 7+ year’s progressive experience in an manufacturing & operations management role at a pharmaceutical manufacturing/distribution facility.
- Previous experience operating under FDA cGMP with a robust understanding of the principles and applications associated with manufacturing operations, maintenance and engineering.
- Previous experience working with auditors, inspectors, and regulatory agencies.
- Previous experience/best practices implementing and using continuous improvement/lean tools such as; Six Sigma, 5-S, Lean Manufacturing, Transactional Lean, etc. to drive improvement.
- Previous experience in designing, managing, and/or operating complex automation processes.
- Previous experience/broad understanding of safety systems and safety regulations, and enforcement of safety rules and policies.
- Demonstrates proven knowledge of business and management principles.
- Demonstrates strong leadership, motivation, teambuilding, communication, and advanced coaching skills that instill a strong sense of mission in a team environment across all levels of organization.
- Demonstrates excellent planning and organizational skills, with the ability to balance production and maintenance needs.
- Demonstrates a strong ability to be adaptable and flexible.
- Demonstrates skills to solve complex problems in a wide variety of high pressure situations which require a high degree of ingenuity, creativity and innovativeness. In situations where precedent may not exist, is able to independently exercise judgment, determine appropriate solution and take action.
Wat bieden wij?
Fagron offers exciting opportunities for personal and professional growth. We provide an open and truly dynamic environment which supports and encourages you to develop your skills and talents.