Senior Manager Validation, Engineering, Maintenance, and Commercial Programs

Company: Catalent Pharma Solutions
Location: Kansas City
Posted on: February 22, 2021

Job Description:

Senior Manager Validation, Engineering, Maintenance, and Commercial Programs Job Description Position Overview: 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 This role reports directly to the Director of Operations and Supply Chain. The Senior Manager utilizes LEAN manufacturing principles to provide processes and systems that operate in an effective manner to positively impact the SQDC of the business. Systems and equipment are onboarded, optimized, validated, and maintained following site Quality Systems requirements and approaches governed by LEAN Six Sigma models to keep the Operators functions up-to-date with the most effective and efficient tools. Equipment is maintained in a compliant and efficient manner following site SOPs. Primary and Secondary Package designs are completed, and tooling is procured and designed to support the package designs. Commercial program lifecycles are governed within this function and include interaction with business development for design, planning, forecasting, and maintenance of commercial programs. This position is key to new product introduction, commercial readiness, and continued process verification throughout the life of the products. The Role Leadership Manage the daily activities of the Process Engineering, Packaging Engineering, Validation, and Maintenance groups Manage appropriate elements of commercial programs to ensure alignment with product lifecycle concepts from inception to discontinuation Sets priorities for the groups to ensure task completion and coordinates activities with other departments Input to Upper Management for strategic planning Capital and expense projects (i.e. equipment and system onboarding) Key process improvements (i.e. equipment optimization, process development, and targeted training) Package design and tooling procurement Validation activities ; p eriodic review of validation and SEP's Technical support to Packaging Operations Planned maintenance (i.e. work orders) Onboard, optimize, and maintain equipment to benefit the packaging and labeling operations Design primary and secondary packages and procure equipment tooling to support packaging and labeling operations Oversee the qualification of equipment, facilities, and processes Oversee Maintenance whose function is to perform planned (Preventative maintenance) and unplanned (work orders and change controls) maintenance for equipment Have an advanced knowledge of the Operations, Standard Operating Procedures (SOPs), and current Good Manufacturing Processes (cGMPs) and the reason for their existence Functions on a day-to-day basis utilizing LEAN manufacturing techniques Performs semi-annual performance and weekly, monthly, and quarterly performance updates related to the four SQDC groups below Safety Responsible for the identification, investigation, and improvement of Safety Concerns (as assigned) Responsible for the identification, investigation, and improvement of Safety Events (as assigned) Quality Responsible for the overall training compliance, including GMP, HR, and Safety training (ComplianceWire) Responsible for the overall quality of output produced, including technical reports and data generation Provides consultation with investigations (discrepancies, deviations and complaints) as well as CAPA identification and closure (as assigned) Delivery Understands the daily, weekly, and Monthly schedule and supervises daily activities to meet on time delivery Responsible for communication between the four groups and other departments - specifically including status of deliverables Cost Responsible for the overall throughput of technical reports Responsible for execution of process improvements to remove waste from the Operations processes Responsible for ensuring resources are available for participation of Facilitation of Continuous Improvement activities (e.g. Process Improvement Group projects and Kaizen Events) The Candidate Bachelor's degree in Engineering, Business or Life Sciences or equivalent knowledge and experience Fifteen years of GMP manufacturing or packaging experience is required Prior training in basics of LEAN manufacturing required Six years of people management is required Five years of equipment related manufacturing or packaging experience Two years of technical writing or equivalent is preferred Certification in LEAN Six Sigma preferred Medical, Dental, Vision and 401K are all offered from day one of employment 19 days of paid time off annually Potential for career growth within an expanding team Defined career path and annual performance review and feedback process Leads with Integrity and Respect Delivers Results Demonstrates Business Acumen Fosters Collaboration and Teamwork Champions Change 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. 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. Posted 16 Days Ago Full time 0047312 About Us 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 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 .--

Keywords: Catalent Pharma Solutions, Kansas City , Senior Manager Validation, Engineering, Maintenance, and Commercial Programs, Professions , Kansas City, Kansas