Customer Service Manager
Resume:
Brian P. Burns
*** ********* ***. . ************, ** 19438, *****@*****.***,
WORK EXPERIENCE
Johnson and Johnson, c/o US Tech Solutions, Lancaster, PA
Operations Manager/Supervisor II
2014-Present
Manage off-shift production of OTC solid dosage products at the McNeil,
Lancaster site which include weighing, blending, milling, compression and
packaging operations. Ensure all areas adhere to applicable FDA
regulations, cGMPs, SOPs and safety and environmental guidelines. Provide
leadership and direction to shift leaders, pharmaceutical technicians and
maintenance technicians. Troubleshoot equipment or process malfunctions
as necessary to ensure adherence to the schedule and meet or exceed profit
plan. Investigate non-conformances and implement corrective/preventive
actions, as necessary to prevent recurrence.
Merck and Co., c/o Spectraforce Technologies, West Point, PA
Senior Process Engineer
2013-2014
Responsible for providing engineering support to HPV vaccine manufacturing
which includes process and equipment troubleshooting, investigating process
deviations, executing validation studies, and authoring technical
documentation. Activities also include managing capital projects and
implementing process improvements to reduce cost and increase productivity
and the development, review and modification of batch records, SOPs,
validation protocols, housekeeping and environmental procedures.
Arkema Chemical, Bristol, PA
Plant Operations Manager
2011- 2012
Managed all plant manufacturing related activities in an acrylic resin
(PMMA) plant including assuring the safe operation of all equipment,
adherence to all safety, OSHA and EPA/DEP regulations as well as assuring
all production, quality and customer service levels are met. Led continuous
improvement activities in safety, quality and efficiency. Partnered with
USW leadership to ensure compliance with the collective bargaining
agreement. Managed operating plan outlining personnel, inventory, capital
expenditures and productivity improvments. Reviewed budget vs forecast
monthly.
Lutron, Coopersburg, PA
Business Unit Operations Manager
2 007- 2011
Managed the strategic business unit's operations, engineering support and
new product introduction teams. Responsibilities included assuring
manufacturing quality, product cost, and delivery metrics of SBU product
line met or exceeded corporate goals. Directed the coordination of new
product introductions and product transitions from one facility to another.
Additional responsibilties included resolving product technical issues,
field issues and identifying continous improvement/lean opportunities.
. Developed global strategic capacity plan to meet a 30% - 50% annual
growth in sales volume utilizing manufacturing sites in PA, VA, China
and Mexico.
. Identified and implemented a number of cost savings initiatives
totaling $500K.
Merck and Co., West Point, PA
1997- 2007
HPV Vaccine Manufacturing Technical Lead (2006-2007)
Managed and resolved technical issues related to HPV vaccine manufacturing
including process deviation investigations, analytical testing, process
improvements, equipment replacement and/or modifications, troubleshooting,
maintenance activities and validation activities. Developed and
implemented process improvements to reduce cost and increase productivity.
Point person for regulatory agency interaction regarding technical issues.
Developed, reviewed and modified batch records, SOPs, validation
protocols, housekeeping and environmental documentation.
. Process and equipment turnaround improvements resulted in 50% increase in
lot completion
. Lean manufacturing initiatives resulted in 2300 labor hours/yr saved
Engineering Technical Support Manager (2002 - 2006)
Managed the engineering and maintenance support activities for multiple
bacterial and viral vaccine manufacturing buildings. Assured all equipment
preventive maintenance and calibration schedules were followed. Supported
either directly or through direct reports the development and
implementmention of capital projects for new equipment, process
improvements and new products from functional requirements through
detailed design including the design, specification and installation
activities for new product/facilities and equipment. Provided oversight
and technical expertise in the authoring, approval and execution of
Installation, Operational and Performance Qualification protocols and
Factory Acceptance Tests. Maintained capital and maintenance budget for
assigned areas. Managed engineering staff of 8-11 chemical and mechanical
engineers.
. Managed a number of key capital projects including the total renovation
of several manufacturing facilities, replacement of WFI systems, air
handling equipment and process vessels.
. Developed a number of site wide maintenance and engineering procedures
that significantly improved consistency and regulatory disposition.
Senior Manufacturing Supervisor (1997 - 2002)
Developed manufacturing schedules, coordinated manning, managed overtime,
and ensured area adhered to cGMPs, SOPS, safety and environmental
guidelines. Provided direct supervision to hourly employees in a multi-
vaccine facility. Assured adherence to the collective bargaining
agreement. Provided guidance, leadership, and training to junior level
supervisors. Troubleshot equipment or process malfunctions. Coordinated
SOP review, MRPII compliance, equipment changeovers, and batch record
review. Reviewed, modified and drafted batch records and SOPs
. Initiated numerous process improvements, which led to significant
reductions in processing time and increased productivity. Increased
capacity of formulation process by 33%.
. Led start-up of new formulation processing suite.
. Led process deviation reduction initiatives in the purification area that
led to a 60% reduction in events.
Education
B.S. in Chemical Engineering (3.64 GPA) - Rutgers University, NJ, 1997
Military
Marine Corps - 3rd Marine Air Wing, Marine Air Group 46, Tustin CA
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