Mechanical Engineer Engineering

** ****** ****

Clifton, Me. *****

cell 207-***-****

Robert J. Bachorik II

Career Summary

Mechanical engineer with over 28 years of experience in management of pharmaceutical manufacturing and research facilities, communication with international, federal and state regulatory bodies, management of preventative maintenance, training, hazardous materials containment and regulatory compliance. Five years of experience with high hazard material processing isolator technology and vaccine production.

Experience

8/2018 - Present Jackson Labs Bar Harbor, Me

Supervisor, Operations Department

Manage the processing of all mouse breeding supplies including cages, water, food and all other supplies for breeding suites.

Support the streamlining and automation of critical activities associated with mouse breeding and care.

5/2014 – 7/2018 Eli-Lily and Co./Elanco Winslow, Me

Sr. Scientist, Engineering Department

Managed commissioning and qualification, and start up of autogenous production building

Designed and performed study to analyze clean process room air quality and flow patterns

Updated room pressure differential indicators

Designed and had fabricated a new mixing vessel and mixer for vaccine inactivation. The design was based around better mixing of components to attain homogeneity in a shorter period of time.

8/2013 – 5/2014 Northeast Laboratory Services Winslow, Me

Director, Facilities and Technical Services

Wrote a Site Master Validation Plan to update the method of validation due to external audit. This included addition of change control forms and additional SOPs to support the new method. Trained manufacturing and operational staff regarding the new method.

Reviewed the water purification system and worked closely with the chemistry department to update and add to their testing methods and periods to reclassify the system as a DI Water System for use in the manufacture of diagnostic media.

9/2012 – 6/2013 Orion Rope Works Winslow, Me.

Manager, Facilities Maintenance Dept.

Developed preventative maintenance program for utilities and equipment.

Organized stock preventative maintenance parts and purchasing system.

Managed rebuild and upgrade of multiple pieces of rope manufacturing equipment.

Managed a software system to trend downtimes and equipment repair in preparation for PM Program.

9/2009 – 8/2011 Elan Pharmaceuticals King of Prussia,PA

Associate Director, Technical Services Department

Reviewed, designed and implemented changes to Elan’s manufacturing space to reduce operating material costs and increase efficiency in clinical development and clinical manufacturing.

In coordination with the QA and Information Systems departments developed and worked as a member of the project team to implement a new materials and asset management database software system to replace an existing and outdated paper based system.

Worked in close collaboration with multiple departments on a two year project to design and implement a new cleaning verification system in line with current industry standards. The project was completed in August of 2011 and met the requirements of a previous audit.

Worked closely with Regulatory, QA and Finance to apply Elan’s nanotechnology to external pharmaceutical company’s new and existing products. This included execution of and follow-up to audits to assure manufacturing was performed to meet the external company’s methodologies, product requirements and time lines.

1998–9/2009 Sanofi-Synthelabo/Sanofi-Aventis Malvern, PA

Manager, Engineering and Technical Systems Group

Engineering project team member of $2M Solid Dosage Pilot Suite project from design through qualification. Suite capabilities include TK Fielder Wet Granulator with 100kg capacity, O’Hara Fluid Bed Dryer with 80kg capacity, Lift Column Bin Blender with 150kg capacity, Medium Capacity Korsch Tablet Press and Futura MG2 Encapsulator.

Managed the replacement, change control and revalidation a Glatt fluid beds historic pneumatic control system with a new OIT control system. Reviewed the design with Glatt and users, requested funding, specified user requirements based on input from users. Revalidated the system and placed it back into clinical manufacturing.

Engineering project team member of $4M High Potency Suite Project from design through qualification. Suite composed of Class 10,000 process room with double airlocks, Getinge cytotoxic autoclave with chamber condensate collection and sampling system, Flanders aseptic and compounding isolator equipped with UPS and integrated Bioquell vaporized hydrogen peroxide sterilization system, semi-automated vial filler, glove port testers, Kaye Validator 2000, Millipore Filter integrity tester and various supporting components for the manufacture of Phase I to IIb aseptic oncology clinical supplies.

Engineering project team member of Cytotoxic lab project from design through commissioning. Capabilities include LaCalhene compounding isolator for pre-clinical development and formulation of solid, semi-solid, oral liquid and injectable oncology compounds.

Managed the preventative maintenance program for all pharmaceutical clinical manufacturing equipment. Tracked part failures and replaced with high quality parts based on company standards, stocked wear parts and FDA approved lubricants with alert/reorder system.

Managed department Safety Committee from 1995 to 2006 with the Health and Safety Department. Close coordination of product pilot suite scale up activities with Health, Safety and Environmental Assurance department.

Member of Project Team assembled to develop an updated site Validation Master Plan. Provided input and technical writing to define the pharmaceutical sciences manufacturing equipment and updated utility needs from a compliance perspective.

Management and qualification of utilities during change controls specifically for clean compressed air, dust collection system, USP Purified Water, changes to the GMP Manufacturing Area HVAC system, increase in the clean steam generator and installation of a plant steam generator to service a newly installed autoclave.

1994–1998 Sanofi-Synthelabo Inc. Malvern, PA

Sr. Pharmaceutical Engineer

Managed purchase, installation and qualification of clinical manufacturing equipment. Acted as engineering liaison between the pharmaceutical sciences department and the facilities engineering department in planning preventative maintenance and large project downtime so as to have as little impact as possible on clinical production. These projects included demolition of two process rooms to create one large process room, increasing ceiling height to allow for larger bin blending and direct loading of hoppers and demolition of floors to resurface.

Managed creation of a departmental equipment Cleaning Verification Program issued as a directive via corporate. All equipment product contact surfaces were measured and documented, cleaning verification forms were created for each individual piece of equipment. Forms were assembled and minimum batch sizes were calculated from user and scientist input. Provided technical support to the Analytical Sciences department in carrying out chemical recovery tests for various materials of construction for equipment product contact surfaces.

1992–1994 Sterling-Winthrop, Inc. Collegeville, PA

Pharmaceutical Engineer

Wrote and executed installation and operational qualification protocols for fluid beds, granulators, blenders, drying ovens, tablet dedusters, capsule polishers and various high shear hammer and compression mills.

Worked with the prefilled syringe project team in development of an autoclave cycle that operates at or below vapor pressure of the imaging agent. This allowed the terminal sterilization of the imaging agent without use of an over pressure autoclave cycle. Worked with project team in transferring this technology to the manufacturing plant in Barcellonetta, P.R.

Patents

5,411,488 Pre-filled Syringe and Pre-Filled Syringe Cartridge Having an Improved Plunger and Plunger Rod for Reducing Syringing Force

5,411,489 Pre-filled Syringe and Pre-Filled Syringe Cartridge Having Actuating Cylinder/Plunger Rod Combination for Reducing Syringing Force

DES 383,205 Combined Syringe and Plunger

Education

1987–1992 University of Maine Orono, Me.

B.S. Mechanical Engineering and Technology

E.I.T (4/92)

LEAN Training

Professional Societies

Software

International Society for Pharmaceutical Engineering

Delaware Valley Chapter, 1995 to 2011

CADkey, AutoCAD 2014, Lotus Notes, MS Excel, MS Word, MS Project, MS PowerPoint, Trackwise, MS Outlook, Siemens Insight 3.8, NextDocs

References Available upon request.

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