Senior Manager Validation, Engineering, Maintenance, and Commercial Programs
Company: Catalent Pharma Solutions
Location: Kansas City
Posted on: February 22, 2021
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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---
Keywords: Catalent Pharma Solutions, Kansas City , Senior Manager Validation, Engineering, Maintenance, and Commercial Programs, Professions , Kansas City, Kansas
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