Director, Engineering - Facilities & Utilities

Company: Catalent Pharma Solutions
Location: Bloomington
Posted on: September 21, 2023

Job Description:

Director, Engineering - Facilities & Utilities page is loaded Director, Engineering - Facilities & Utilities Apply locations Bloomington, IN time type Full time posted on Posted 2 Days Ago job requisition id 0078203 Director, Engineering - Facilities & Utilities
This is a full-time, salary position.SummaryCatalent Biologics is a fast-growing business within Catalent Pharma Solutions focused on providing innovative technologies and solutions to help more and better biologic treatments get to patients. The business includes our proprietary GPEx cell line engineering platform, our new state-of-the-art biomanufacturing facility in Madison, WI, and our market leading biologics analytical services in Kansas City, MO and Research Triangle Park, NC, as well as SMARTag Antibody Drug Conjugate technology in Emeryville, CA. Leveraging our growing differentiated technology portfolio, world class manufacturing capability, and other integrated services across the Catalent network, Catalent Biologics is positioned to drive significant growth for Catalent.
Working for Catalent Biologics is an opportunity to join an entrepreneurial team. Catalent Biologics is making significant investments in people and capabilities. This is a unique opening to join a small, fastgrowing business, backed by a global public company. People joining our team will have the opportunity for career development as our business continues to grow and expand. Catalent employees are helping to improve future patient outcomes by working on products that are designed to treat COVID-19, cancer, various autoimmune, fibrotic and blood disorders, HIV, diabetes, heart, and lung diseases as well as Alzheimer's.Department Overview:
Maintenance/Facilities is responsible for all facilities operations, maintenance, and calibration of direct and indirect equipment to the manufacturing process, and project management for expansions or remodeling. This department manages facilities planning, construction, and renovation, including primary contact and management of architects, design engineers, contractors, and subcontractors. The Facilities Department is also responsible for managing the facility in a manner that assures uninterrupted cGMP compliance in existing manufacturing areas, as well as the research and process development areas.
Specific Duties, Activities, and Responsibilities:The Engineering Director will receive assignments in the form of annual (site specific) objectives (projects) and develop goals to meet those project objectives. This individual may establish new SOPs and/or recommend changes to current SOPs based on facility needs. This person will work on complex facility related problems requiring in depth analysis of data to determine appropriate action. Poor decisions related to facility operations could result in delay of business operations and lead to project delays, which could ultimately jeopardize site business activities. This person is expected to have extensive communication with employees and cross functional group managers/departments on facility related issues. The Engineering Director is responsible for providing guidance to employees according to established policies and management guidance.The Engineering Director oversees facility engineering, operational technologies, calibration, maintenance, and equipment maintenance staff and is responsible for execution of day-to-day support necessary to maintain the building systems in an operational state and in compliance with regulatory requirements for biopharmaceutical manufacturing. The incumbent assists in budgeting building projects, obtaining quotes, negotiating with vendors, and supervising outside contractors engaged in the provision of repair, renovation, and construction services.

• Responsible for the development, implementation, and ownership of a comprehensive CI, engineering, maintenance, technical services, manufacturing technology roadmap, metrology, and facility strategy
• Organize, manage, develop, and implement project plans, construction projects, designs, assembly of equipment, processes, and systems to ensure timely project completion in compliance with regulatory agency requirements, internal company standards, and current industry practices
• Contribute to the company's overall probability and growth strategy
• Manage multi-use facility, including HVAC systems and bio-containment systems
• Responsible for acceptance and installation of manufacturing equipment
• Work with facility commissioning/validation team, including operational protocol development, to implement compliance with cGMP requirements
• Ensure proper investigation and prompt closure of department deviations
• Draft Standard Operating Procedures (SOPs) for building operation, maintenance, and security
• Ensure staffing for 24/7 coverage of the facility
• Manage facility preventative maintenance
• Provide guidance and execution on facilities and equipment projects
• Manage day to day facility activities, including supervision of the facility/maintenance staff
• Manage outside contractors
• Support site planning
• Oversee the calibration program and train staff on calibration techniques/procedures
• Perform hands on activities as needed
• Lead team members to improve and reinforce performance of others
• Take responsibility for direct reports performance by setting clear goals and expectations, tracking progress against the goals, ensuring constructive feedback, and addressing performance-related concerns and issues promptly
• Work with, coach, and support direct reports in developing knowledge, skills, and abilities in the interest of performance improvement and employee's career development
• Other duties as assignedPosition Requirements:
  Education/Experience:
  • Bachelor's degree in science, engineering, or technical study, required
  • Master's degree, preferred
  • 15+ years Continuous improvement, manufacturing technology experience
  • 15+ years of progressive Engineering management experience
  • 5+ years in a regulated industry (Life Sciences, preferred)
  • OSHA 10, preferred
    Dimensions of Position:
    Scope of Responsibility:
    • Reports to: Senior Director or above
    • Direct Reports: 5 - 8
    • Total Site Staff (includes directs): 30 - 40Physical, Safety and Behavioral Requirements of the Position:
      Technical Requirements:
      • Background in management of HVAC systems
      • Proficiency with process definition and project management, strong communication skills, and proven ability to be a team leader
      • Continuous improvement
      • Contract management
      • People management and development
      • Engineering acumen
      • Regulatory and compliance expertise (cGMP) for biopharmaceutical production
      • Strategic planning and influencing stakeholders
      • Project management and resource forecasting and planning
      • Word processing and spreadsheet skills, engineering software such as AutoCad or equivalent
      • Knowledge of PLC programs and compliant control systems (automation and networking)
      • Ability to absorb and process multiple information inputs on a variety of subjects and formulate meaningful long-term solutions while balancing the site needsBehavioral Requirements:
        • Ability to see and hear, read, and write clear English.
        • Requires adaptability, analyzing, assessing, calculating, decision making, dependability, good judgment, reading, memorizing, social skills, speaking, stress control, writing.
        • Ability to communicate effectively and follow/retain detailed written and verbal instruction in an accurate, timely, safe, and professional manner with supervisor, group members, and other departments as necessary, in a professional and accurate manner
        • Ability to manage time effectively to complete assignments in expected time frame and independently seek out additional work when tasks are completed ahead of time
        • Ability to cooperate with coworkers within an organized team environment or work alone
        • Detail oriented with ability to work effectively under high pressure with multiple deadlines.
        • Strong ability to multi-task in a fast-paced environment.
        • Positive attitude and ability to work with others.
        • Ability to process a large volume of work.
        • Ability to effectively carry out and implement change.
        • Ability to put aside personal opinions and focus on business needs, department needs, or group needs.Leadership Requirements:
          • Establishes an effective, professional, and positive relationship with employees.
          • Clarifies responsibilities and expectations and holds employees accountable.
          • Participates in and conducts timely HR-related processes.
          • Provides timely constructive feedback that is clear and direct.
          • Provides guidance on how to strengthen knowledge, skills, and abilities to improve personal and organizational performance.
          • Uses appropriate methods and flexible interpersonal style and coaching to develop others' capabilities
          • Recognizes and reinforces developmental efforts, progress, and improvements.
          • Collaboratively works with direct reports to set meaningful performance objectives.Safety and Environmental Requirements:
            • Frequent sitting, standing, walking, climbing ladders/steps, reading of written documents and use of computer monitor screen, reaching with hands and arms, talking, writing, listening.
            • Occasional stooping, kneeling, crouching, bending, carrying, grasping.
            • Frequent lifting and/or moving up to 10 pounds and occasional lifting and/or moving up to 50 pounds.
            • Must comply with EHS responsibilities for the position.
            • Working conditions will be heating ventilation and air condition controlled.
            • Working in a lab environment will require working with skin irritants, lung irritants, electrical equipment, sharp instruments, toxic materials, and hazardous waste. Safety procedures will be followed to minimize exposure, including clean room gowning.Business Environment:
              • Fast-paced
              • Performance driven
              • Customer focused
              • Collaborative and inclusive
              • Team playerAbout Catalent:
                Catalent Pharma Solutions is the leading global provider of advanced delivery technologies and development solutions for drugs, biologics and consumer health products. With over 80 years serving the industry, Catalent has proven expertise in bringing more customer products to market faster, enhancing product performance and ensuring reliable clinical and commercial product supply. Catalent is headquartered in Somerset, N.J. For more information, visit www.catalent.com.
                To perform this job successfully, an individual must be able to perform each duty satisfactorily. The requirements listed above are representative of the knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
                This job description reflects the general duties of the job but is not a detailed description of all duties which may be inherent to this position.
                Catalent may assign reasonably related additional duties to individual employees, consistent with company policy.Catalent offers rewarding opportunities to further your career! Join the global drug development and delivery leader and help us bring over 7,000 life-saving and life-enhancing products to patients around the world. Catalent is an exciting and growing international company where employees work directly with pharma, biopharma and consumer health companies of all sizes to advance new medicines from early development to clinical trials and to the market. Catalent produces more than 70 billion doses per year, and each one will be used by someone who is counting on us. Join us in making a difference. -Catalent is committed to the health and safety of its employees, visitors and the customers and patients we serve. As a result of the global pandemic, we have modified many of our recruitment and on-boarding processes to maintain everyone's safety. The Human Resources teams will communicate all necessary safety processes and procedures throughout each stage.personal initiative. dynamic pace. meaningful work.Visit Catalent Careers to explore career opportunities.Catalent is an Equal Opportunity Employer, including disability and veterans.If you require reasonable accommodation for any part of the application or hiring process due to a disability, you may submit your request by sending an email, and confirming your request for an accommodation and include the job number, title and location to DisabilityAccommodations@catalent.com . This option is reserved for individuals who require accommodation due to a disability. Information received will be processed by a U.S. Catalent employee and then routed to a local recruiter who will provide assistance to ensure appropriate consideration in the application or hiring process.Notice to Agency and Search Firm Representatives: Catalent Pharma Solutions (Catalent) is not accepting unsolicited resumes from agencies and/or search firms for this job posting. Resumes submitted to any Catalent employee by a third party agency and/or search firm without a valid written & signed search agreement, will become the sole property of Catalent. No fee will be paid if a candidate is hired for this position as a result of an unsolicited agency or search firm referral. Thank you.Important Security Notice to U.S. Job Seekers:Catalent NEVER asks candidates to provide any type of payment, bank details, photocopies of identification, social security number or other highly sensitive personal information during the offer process, and we NEVER do so via email or social media. If you receive any such request, DO NOT respond- it is a fraudulent request. Please forward such requests to spam@catalent.com for us to investigate with local authorities.California Job Seekers can find our California Job Applicant Notice HERE . About Us Catalent = Catalyst + TalentYour talents, ideas, and passion are essential to our mission: to develop, manufacture, and supply products that help people live better, healthier lives. Join us!personal initiative. dynamic pace. meaningful work.Catalent is the perfect place to grow your career if---
                • You enjoy the fast pace of a start-up, but want the opportunities and stability of a growing, publicly traded company (Listed on NYSE: CTLT).
                  • You want meaningful work. From cough treatments to cancer-fighting drugs, biologics, and vitamins, we help develop, launch, and supply over 200 new products each year - more than any branded drug maker in the world!
                    • You want to plant your career in a growing company. Over the last five years, Catalent has re-invested more than $2 billion back into the company and its people.
                      • You are excited about learning, collaborating, and growing alongside a global diverse team. Our team of more than 11,000 comes to work every day ready to overcome new challenges with teamwork, advanced technologies, and a passion to deliver by putting patients first.
                        • You want to make a global impact! From North America to Europe, Asia to Latin America, we have innovative science and manufacturing teams who are looking for YOU!
                          • See how our teams are making a difference, while growing their careers and fulfilling our mission by putting patients first every day here . -
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Keywords: Catalent Pharma Solutions, Bloomington , Director, Engineering - Facilities & Utilities, Executive , Bloomington, Indiana