Engineering Engineer
Resume:
Tanya Chavez-Cropp
****Bartwood Dr
Raleigh, NC 27613
************@*****.***
CAREER SUMMARY
M.S. chemical engineer with nineteen years of experience in the vaccine,
biotechnology and semiconductor industries. More than nine years of
experience managing direct reports, engineering project team members,
interns and contractors. Expertise in managing multiple large projects at
one time, improving equipment and process control, root cause analysis, and
handling emergencies. Recognized strengths include leadership, teamwork,
problem solving and achieving results.
SKILLS SUMMARY
OPERATIONAL EFFECIENCY: TPS, PM optimization, RCM, ASTM2500, Lean, PDCA,
SLA, ACT and Catalyst
COMMERCIALIZATION EFFORTS: New product introduction, Tech transfer, Space
planning/layout, Facility design, Vendor selection, Defining equipment
specifications, URS, FRS, DDS, PFD and P&ID development
ENGINEERING PROCESSES: cGMP, CCMS, TrackWise, Maximo, LOTO, PM, SOP, MP,
NC, CAPA, EH&S, JHA, Safety audits, IQ, OQ, PQ, Periodic monitoring, FMEA,
RPN, DOE, SAT, FAT, Regulatory support, QA and Val requirements, Gap
analysis
PROCESS EQUIPMENT: Roller Bottle cell culture, Column chromatography,
Membrane chromatography, Column packing, Cell culture, UF/DF, Viral and
Depth Filtration, Buffer prep, Buffer hold, Autoclave, Integrity test,
Process analytical technology, CIP, Biowaste
BIOTECH PROCESSES: Vaccine, Monoclonal Antibody, Microbial, Mammalian,
Multi-host
PROFESSIONAL EXPERIENCE
MERCK MMD, Durham, NC
2011-present
Viral Vaccine Technology & Engineering
Director Engineering
2013-present
Lead the technology transfer/strategic project team for the site. The
site consists of an 18 robot bulk manufacturing facility and a two
filling line form fill facility. Accountable for product tech
transfers into the form fill facility and 70% throughput increase over
basis of design in the bulk facility. Manage 23 full time employees, 4
contractors and report to the Executive Director of Engineering.
. Guided site and franchise to align on strategic priorities.
Established achievable goals and a robust plan to realize those goals.
Influenced and gained consensus on strategic project prioritization
and timing up through Senior Vice President of Operations.
Subsequently guided team to deliver 100% on target milestones.
. Doubled throughput of existing bulk facility one month ahead of
schedule through process improvements and Lean methodology.
Maintained safety, deviation, yield and process performance metrics
throughout the ramp-up in production. Achieved success through
focused and innovative approaches to collaboration, communication,
and engagement with the Integrated Process Team.
. In form fill facility, successfully steered MMR from PPQ execution,
submittal of license applications in two countries, application
support during PAI in two countries, and EU approval in less than one
year (four months ahead of target). Additionally, executed
development runs to solidify process in second tech transfer product,
minimized bulk usage, and began PPQ execution one month ahead of
original plan. Frequently overcame substantial challenges and
maintained critical milestone timeline by encouraging creative
thinking, resilience, and holding my team and other teams accountable
for results.
. Site representative for six above site technical and supply chain
governing groups. My contribution solidified our relationship with
the sending site and built confidence and trust in Durham progress.
. Integrated the bulk and form fill tech transfer teams which had
previously worked independently. Set expectations for team to share
best practices and work together on items such as tech transfer
standard work, project management, and automation requirement
specifications. Held frequent team meetings and off site gatherings
so team could build relationships and become a cohesive team.
. In collaboration with Executive Director, managed annual department
budget, department hiring, succession planning, long range operating
plans, and actions to improve Voice of Customer survey results.
Associate Director Engineering
2011-2012
Lead the capacity expansion branch of the technology team in a 12
Robot roller bottle cell culture facility. Accountable for two of the
seven 2012 goals for the bulk facility: expand the manufacturing
facility by 50% through capital expansion and increase throughput of
existing facility by 70% through process improvements and Lean
methodology. Manage six direct reports and three contractors, report
to the Director of Engineering.
. Startup Lead of a six robot facility expansion. Partnered with
Global Engineering Services in the facility design,
qualification, startup and process demonstration activities.
Served as bridge between the project team and site
Manufacturing, Quality, Automation, Plant Engineering and
Validation teams to ensure process and operational requirements
were fully understood and processes were validated to be
reliable, consistent and meet cGMP standards.
. Significantly accelerated project schedule. Completed OQ
activities 9 months ahead of original target. Achieved
acceleration via creative thinking that allowed water runs and
engineering runs to occur prior to combining the expansion and
existing facility. Successfully held functions accountable for
deliverables by utilizing effective methods of prioritization,
tracking and appropriate elevation.
. Lead of bulk throughput improvement effort with goal of
increasing throughput of facility utilizing Lean methods and
little to no capital expenditures. Project started at concept
phase. Modeled facility throughput and designed scenarios to
optimize equipment and operator utilization. Analyzed
theoretical max output and actual output of all equipment,
utilities, warehouse, vendors, and support infrastructure with a
focus on "go see". Identified bottlenecks to achieving modeled
capacity. Initiated and completed operational efficiency
projects to relieve bottlenecks and eliminate waste. Achieved
76% increase in throughput over startup production rate and on
track to increase throughput 70% over basis of design by 2015.
. Focus on personal and team development. Hired and led team of
six engineers to achieve the above goals with passion and
optimism. Inspire trust and respect by personally doing what I
ask of others. Routinely give and solicit feedback to improve
team communication, empowerment and accomplishments. Actively
pursue improvement opportunities by participating in programs
such as Merck's six month "Breakthrough Leadership" program.
SHIRE HGT, Lexington, MA
2009-2011
Engineering
Manager Engineering
2009-2011
Lead the engineering function which supports the manufacture of
commercial and clinical bio-tech products in a 10,000 roller bottle
cell culture facility. Represent the engineering function to other
functional groups such as Quality, Validation, Process Development,
Manufacturing, Facilities, and Engineering at two other sites. Ensure
the quality of work and appropriate engineering resources are in place
to support the design and implementation of Capital Projects as well
as 24/7 manufacturing operations. This position reports to the
Senior Director of Engineering and is a key member of the Site
Steering Committee.
. Plan, organize, coordinate and communicate the work of the site
engineering team which consists of process, CIP and automation
engineers. Team is accountable for all utility and process
equipment within the Roller Bottle facility. Utilize knowledge
of biotech processing methods, equipment and validation to
provide guidance and technical advice to direct reports as
needed.
. Key member of Site Steering Team responsible for developing site
goals and objectives, defining annual capital projects and
budget, meeting plant metrics and regulatory compliance
commitments. Joined the team midway through the process of
successfully constructing a new Roller Bottle facility, bringing
it through engineering runs, process validation runs, and FDA
Pre Approval Inspection within 1.5 years.
. Championed creation of a multi-disciplinary Project
Prioritization team to fill unmet site need of communicating,
coordinating and prioritizing all site projects and initiatives.
Solicited team member feedback to refine the process and add
scope to the meeting.
. Significantly increased the level of engagement and development
of my staff by encouraging them to implement their own ideas for
cross functional collaboration and by working with engineering
managers at other sites to create development opportunities.
AMGEN INC., Boulder, CO
2003-2009
Manufacturing
Manager Engineering/Senior Engineer
2005-2009
Created job descriptions, interviewed, hired, trained, supervised,
guided development and provided evaluations for full time employees.
Championed opportunities for change by representing the plant
engineering group in key commercialization efforts and lean
manufacturing initiatives.
. Managed four direct reports, two senior engineers and two
engineers. Team was accountable for all Purification equipment
and processes in a new product introduction facility responsible
for the commercialization of three peptibody and one monoclonal
antibody product. Purification operations range in scale from
45 cm to 160 cm column chromatography. Provided guidance and
technical advice to direct reports as needed.
. Responsible for cascading EH&S information to Plant Engineering
(PE) group monthly, leading PE managers in converting site goals
into actionable objectives and plans for the PE team, leading PE
management in developing and executing operational improvements
within our group, leading PE efforts in reducing the overall
cost of maintenance at Amgen CO (both Longmont and Boulder
sites) and representing PE on the compliance "Audits and
Stakeholders" team.
. Lead engineer in the technical transfer of a phase II clinical
product into GMP manufacturing operations. Core team was
comprised of cross site and cross functional members and proved
that the facility equipment and utilities were capable of
producing the molecule with minimal modifications to the plant.
Made key equipment and processing decisions in order to meet
budget and schedule goals.
. Out of 25 engineers and three senior engineering managers, was
selected by the Director of Engineering to represent the PE
department on a $38M expansion project. This role is typically
assumed by the Director, but was granted to me because of
recognized leadership abilities and expertise on all
purification process equipment. Team developed detailed design
of the building expansion, P&IDs, equipment specifications, user
requirement specifications, process hazard analysis and
validation plans. Influenced and negotiated between the project
team members and the system owner group which ultimately allowed
all design to be complete and all process equipment to be
purchased on schedule and within budget.
. Catalyst for change in engineering group. Identified need to
cross-train engineers on equipment and need for managerial
development opportunities. Proposed a new organizational
structure which enhanced knowledge transfer, training,
individual development and attention to global initiatives. As
a result, was selected to be the first senior engineer to have
direct reports in the Plant Engineering (PE) group. Efforts and
success have led to the duplication of this model under other
senior engineers.
. In charge of team that partnered with site leadership and VP of
Colorado Operations to help incorporate and capitalize on
diversity as a way to deliver better business results.
Consequently, site leadership adopted our recommendations on how
to leverage diversity thinking into strategies for achieving
2007 site goals.
Senior Engineer
2003-2005
Troubleshot and determined root cause of problems and provided
optimization strategies for four product lines in a multi-host, FDA
regulated cGMP manufacturing facility. Ensured a large number of
highly complex pieces of purification process equipment and systems
remained within their validated state and regulatory compliance. Led
system improvement efforts in conjunction with Manufacturing, Process
Development, Maintenance, Quality Assurance, Regulatory Compliance and
Validation.
. Initiated and led cross departmental team in proactively
reviewing every step and instruction in 12 chromatography
control recipes that were historically riddled with errors.
Managed 14 Change Control records simultaneously to fix the
errors prior to production campaign. As a result, there were
zero production delays, zero non-conformances and zero manual
manipulations needed.
. Executed introduction of two new products into Purification
equipment, making our site the first and only multi-host
facility in the world. This included Failure Mode and Effect
Analysis, new equipment evaluations and PFD/P&ID/automation
recipe development.
. Anticipated and prevented potential problem of missing critical
deadline by requesting and managing a project team of two
contract engineers and two Amgen engineers. Trained team
members, developed schedules, set intermediate goals, motivated
the team and turned company goal of delivering a product on time
into actionable objectives and plans. By effectively utilizing
this team, became the only plant engineer to validate all
changes needed for all three products made in the facility at
the time. This comprehensive approach to new product
introduction allowed the company to switch products in an FDA
regulated environment in real time fashion, effectively saving
four weeks of engineering time in four departments every time
products are switched.
. Innovated solutions to problems that had loosely defined
objectives and required investigation of a large number of
variables. For example, developed a new method for transferring
product from one piece of equipment to another that eliminated
chronic problem of product foaming.
. Ensured process equipment systems remained within their
validated state by providing technical reviews of system
evaluations, validation protocols, change evaluations and
manufacturing documents.
. Led product impact and root cause assessments for nonconformance
investigations.
AGILENT TECHNOLOGIES (formerly Hewlett Packard)
1995-2003
Integrated Circuit Business Division, Fort Collins, Colorado
Research and Development Engineer
Manufacturing Group (Back Half)
1999-2003
Introduced new technology into ISO9000 and ISO14000 high volume
manufacturing facility. Extensive experience with design of
experiments, qualification, validation, and documentation in a heavily
regulated industry. Developed, characterized, implemented, monitored
and improved device level integrated circuit processes.
. Created and led a team of six process engineers and two design
engineers in determining the feasibility of using in-house
equipment to manufacture a new optical lens product. Project
ultimately reduced cost from $20/lens to $0.10/lens in five
months.
. Out of 50+ engineers, was selected to be on a team of four to
introduce a cutting edge Gallium Arsenide process to our
facility. The technology, process, tool set, and wafer handling
was entirely new to Agilent. Learned the technology and took it
from concept through design, development, validation and finally
full manufacturing release. As a result, we were able to enter
new markets with new products and gain new customers.
. Increased tool utilization from 80% to 90% by analyzing and
revamping entire set of preventative maintenance and operational
procedures with a team of technicians and operators.
. One of three company representatives in national forum to reduce
global warming gas emissions to 10% less than 1995 levels by
2010 (goal established by World Semiconductor Council).
Manufacturing Development Engineer
Manufacturing Group (Front Half)
1995-1999
Troubleshot equipment and processes, led cross-functional teams,
developed new processes, improved process control, upgraded and
purchased equipment, and maintained solid working relations with
operators, technicians, vendors, and facilities engineers so that our
semiconductor manufacturing line ran continually and metrics such as
cycle time and yield improved.
. Coordinated selection, purchase, acceptance, installation,
validation, and startup of new generation vertical furnaces.
Managed the project so all scheduling goals were met and
capacity was increased in time for a large ramp in orders.
. Created an alert/alarm system for furnaces. Tracking data from
this system allowed root cause of problems to be identified and
fixed before aborts occurred. The number of alarms decreased
from 60% to 10% and aborts were virtually eliminated. This
decreased the amount of engineering, maintenance, and operator
time used in firefighting problems as well as reduced the amount
of scrapped product.
. Standardized operation of 24 horizontal furnaces thus improving
process control and allowing our product to consistently meet
quality specifications.
. Optimized maintenance procedures by forming a team of
technicians so equipment is returned to operators fully
functional. This significantly increased furnace uptime and
decreased the need for engineering intervention after
maintenance.
. Led a team of operators and engineers in creating trouble-
shooting guides for the horizontal furnaces. This improved
operator performance by empowering them to qualify tools after
maintenance and solve a multitude of problems before needing
engineering intervention.
ADDITIONAL EXPERIENCE
Coors Brewing Company, Ribozyme Pharmaceuticals Inc., Sandia National
Laboratories, Mobil Exploration and Production U.S.
EDUCATION
UNIVERSITY OF COLORADO, Boulder, Colorado
1994
MS in Chemical Engineering, Specialization in Biotechnology
NEW MEXICO STATE UNIVERSITY, Las Cruces, NM
1991
BS in Chemical Engineering
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