Catalent Pharma Solutions Engineering Project Director in Kansas City, Missouri
Catalent hires people with a passion to make a difference to the health of millions of people globally. Your expertise, coupled with Catalent’s advanced technologies and collaboration with thousands of innovative pharmaceutical, biotech and healthcare companies, will help bring life-enhancing products to the people you know and love. Your talents, ideas and passion are essential to our mission; to develop, manufacture and supply products that help people live better, healthier lives. Interested in learning more about life at Catalent? Start here (http://www.catalent.com/index.php/about-us/Catalent-Careers2)
Catalent’s Kansas City facility is home to our Oral & Specialty Drug Delivery, Biologics Analytical Services and Clinical Supply Services businesses. The site provides a range of integrated services for oral solid dosage forms, from formulation development and analytical testing to clinical and commercial-scale manufacture.
The Engineering Project Director will initially lead and manage a $100M site expansion to install Catalent’s Zydis technology within the US from concept through to facility start up and hand over to the operations for commercial delivery. The Engineering Project Director is expected to follow global processes and best practices for execution and ensure that both the internal and external teams and resources have the necessary structure and strategies to successfully deliver this critical investment to the OSD business unit. The candidate must possess strong leadership and management competencies and be able to effectively communicate at multiple levels within the Catalent organization. Zydis Engineering leader responsible for capital and expense project delivery encompassing GMP facilities, equipment, utilities, and interactions with existing site teams.
Direct the planning, design, and implementation of the Zydis US expansion project.
Establish a business partner relationship with the project stakeholders and establish the goals, processes, execution plans and communication plans that define the expected project outcomes and ways of working.
Accountable for project management through the entire workflow including scope development, detailed engineering, execution, commissioning, qualification, turnover to operations and close out meeting all stakeholder and corporate engineering requirements.
Demonstrated ability to manage large, strategic capital projects on tight timing and resources & directly be responsibility for capital projects, cost control, project schedules, and direct/indirect expenses.
Develop and retain talent within the project.
Ensure all facilities and production equipment meet regulatory requirements (cGMPs, safety, and environmental)
Ensuring the full compliance to OSHA and cGMP regulations always and working in concert with a cross functional team to ensure that the engineering projects meet the required standards of the internal and external customers.
Accountable for project governance, including managing the Steering Committee process and communicating performance metrics, risks, and milestone progress
Execute capital plan in compliance with applicable codes, regulations, and company standards.
Work with Procurement and Legal to establish engineering contracting strategies. Serve as the business owner of these contracts. Manage these contracts through their lifecycle, from bid and award, through execution and closeout.
Develop and regularly update the strategic capital improvement plan including site master plan & maximize the success rate for production operations by instituting programs to minimize mechanical failure and enhance equipment performance.
Support the sites ability to win new business with urgent and accurate capital project scope definition and cost estimates to support strategic partnerships with our customer’s proprietary technologies.
Recruit top talent with every hiring opportunity and motivate/develop members of the department to be key leaders within the organization. Build and sustain employee engagement by creating a culture of efficient execution and an environment in which individuals and team can excel and continuously improve.
Demonstrated experience leading large capital projects (> $50M) in a cGMP and pharmaceutical processing environment. Industry experience ideally 15+ years
Bachelor of Science in Engineering from an accredited university. Advanced (MS or MBA) degree, P.E. or EIT is a plus. OSD experience a plus
Minimum 10 years’ experience in engineering/engineering management, preferably in a pharmaceutical/FDA-regulated work environment.
Substantial operational engineering experience with full understanding of pharmaceutical supply chain.
Experienced working on all aspects of capital projects, including budgeting, design, validation, start-up, and ongoing operations.
Demonstrated leadership of quality improvement methods such as LEAN, Six Sigma
Experience working to regulatory standards: FDA, Good Engineering Practice (GEP), Good Manufacturing Procedures (GMP) and Good Documentation Procedures (GDP)
Catalent’s standard leadership competencies
Leads with Integrity and Respect
Demonstrates Business Acumen
Fosters Collaboration and Teamwork
Engages and Inspires
Coaches and Develops
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 www.catalent.com/careers to explore career opportunities.
C atalent is an Equal Opportunity / Affirmative Action employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability, protected veteran status, sexual orientation or gender identity. 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.
Catalent = Catalyst + Talent
Your 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 (https://catalent.wd1.myworkdayjobs.com/External) 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 (https://www.youtube.com/playlist?list=PLuUGqEwwnH7hBwFlrsfSOH_raQHu4hOBK) .