Manager Engineering

Mark R Famulare

Phone: 484-***-**** E-Mail: ************@*****.***

SUMMARY

Over 12 years’ experience in the Biotech/Pharma industry. With a background in Production, Manufacturing, Validation, and Process Development. An enthusiastic individual that excels in a fast paced environment that is driven to obtain a job within my chosen field that will challenge me and allow me to use my skills and past experiences in a way that is mutually beneficial to both myself and my employer and allow for future growth and advancement.

PROFESSIONAL EXPERIENCE

Novartis, East Hanover New Jersey Mar 2016- Jun 2016

Department of Lab Animal Services, Validation Specialist

Executed walk downs to verify the process was accurate and was reflected correctly in the Final report.

Wrote the Re-qualification/Re-evaluation reports for multiple pieces of equipment.

Verified all calibration and preventive maintenance was up to specification.

Reviewed any open change controls and investigated if the change order was completed without being signed off.

Sanofi Pasteur, Swiftwater, Pennsylvania Mar 2015- Jan 2016

Department of Manufacturing Technology. Regulatory Process Documentation Manager

Executed assigned action items in Trackwise for changes needed in the Process Book database.

Reviewed Batch Records to ensure they completely capture the process being followed during production.

Worked with SME’s to close out deviation investigation and action items in Trackwise.

Johnson and Johnson ITS, Raritan, New Jersey May 2014- Mar 2015

Department of Quality and Compliance, Documentation Specialist

Reviewed the Knowledge Article Database to identify any documents that should under Quality control.

Updated the department SOP’s to conform with the current quality standards in place.

Responsible for training team members on correct cGMP and GXP Good Practices.

SDLC methodology and validation on various ADOBE software platforms.

Managed the Quality EDMS and HPQC database.

Ortho Diagnostics/Johnson and Johnson, Raritan, New Jersey Mar 2014- May 2014

Department of Red Blood Cell Manufacture, Scientific Technical Writer-Validation

Hands on field execution Calibration/Validation of Ortho Biovue Centrifuge systems.

Implemented Change Orders pertaining to production and manufacturing processes.

Investigated Non Conformances and decided a corrective action/ path forward.

Meuller Martini, Allentown, Pennsylvania Nov 2013- Mar 2014

Department of Engineering. Engineering Technical Writer

Developed engineering equipment manuals specific to each customer site.

Worked with the engineering team on mechanical deviations to determine a corrective action and path forward.

Controlled the Engineering Change Order system and implemented any change orders to the Bills of Material.

Maintained the electronic library of all customer invoices of purchased equipment.

Merck Pharmaceuticals, West Point, Pennsylvania Nov 2011- May 2012

Department of Sterile and Liquids Pilot Plant. Scientific Technical Writer II

Worked with Quality Assurance to create/revise SOP’s that were affected by new process changes.

Reviewed documents for cGMP compliance and routed to Quality for review and approval through MIDAS.

Met with the technicians regularly to discuss any changes to procedures that could make the process more efficient.

Worked with the department training coordinator to create training aides for the technicians.

Sanofi Pasteur, Swiftwater, Pennsylvania Jan 2011- July 2011

Building 55 C.Difficile Project

Department of Manufacturing Technology. cGMP Documentation Specialist

Maintained project software platform where all drawings and documents were electronically stored.

Developed the template for Engineering Turnover Packages (ETOP) for future capital projects.

Assisted the CQ team in reviewing documents needed for Commissioning and Qualification of equipment.

MARK FAMULARE PAGE TWO

Building 59 Process Development Support for Flu High Dose Jun 2010- Jan 2011

Department of Manufacturing Technology. Process Development Support Specialist

Trained manufacturing personnel on SOP’s/SWI’s.

Provided support, coverage, and guidance for manufacturing personnel with field execution activities.

Responsible for sampling, delivery of samples, and management of sample documentation.

Recorded any deviations during the process and worked with the project team to implement corrective action.

Provided guidance to manufacturing personnel during production failures to find a corrective action/path forward.

Merck Pharmaceuticals, West Point, Pennsylvania Mar 2010- May 2010

Department of Sterile Process Technology and Engineering. cGMP Document Specialist

Reviewed Master Batch Records to ensure cGMP compliance and correctness.

Worked as part of a project team to plan and implement new documentation for new filling and formulation processes.

Tracked and reported progress of project documents to management and manufacturing.

Reviewed documentation used by production to ensure it was completed correctly and conformed to cGMP compliance.

Sanofi Pasteur, Swiftwater, Pennsylvania Sep 2009- Jan 2010

Building 56 Remediation Project

Department of Manufacturing Technology. Validation Specialist.

Responsible for protocol execution, review, and compiling summary reports.

Submitted documents in documentum for review and addressed any comments from Quality Assurance.

Performed deviation investigations, identified corrective and preventive measures, and evaluated process impact.

Reviewed draft summary reports against the data pack to ensure conformance.

SDLC Validation and testing on Human Machine Interface platforms.

Formulation and Filling Apr 2009- Sep 2009

Department of Industrial Operations. Document Coordinator

Reviewed batch records for missing information and errors to assure cGMP compliance.

Met with production personnel to make corrections. Obtain review signatures and report deviations to Quality.

Responsible for providing Batch Record Reconciliation and Good Document Practices training to production.

Supervised the In Process Product Checks to ensure non-conforming product is properly segregated/quarantined.

Authored/edited master batch records and followed up with approvers to ensure timely completion.

Building 37 Retrofit Project May 2008- Feb 2009

Department of Site Services. Document Control Supervisor

Was the primary administrator of the projects electronic file system Buzzsaw.

Helped to develop an SOP for the B37R project regarding Project Turnover, from the CM to the Client.

Provided all requests for information from the project team, both in hard copy and electronic forms.

Acted as the sole point of contact for receiving and sending project documentation between the vendor and client.

Assist the CQV team in verifying documents needed for Commissioning, Qualifying, and Validating of equipment.

Formulation and Filling Project Sep 2006- May 2008

Department of Site Services. Document Control Supervisor

Liaison for Quality Assurance and Site Services between the Construction Manager, and contractors.

Facilitated weekly meetings with the Construction Manager; resolving validation issues regarding incomplete

documentation needed for the close out of systems.

Maintained, assembled and updated Engineering Turnover Packages, Maintenance manuals and

Commissioning and Qualification documentation 140 systems.

Lockwood Greene Engineering, Somerset, New Jersey Jun 2001- May 2006

Department of Site Services. Office IT Project Manager

Set up work stations and installed required software and applications for new users.

Researched and reviewed cost saving measures with purchasing and other departments.

Initial computer troubleshooting of both hardware and software issue.

Administrator of all office network security appellation’s.

MARK FAMULARE PAGE THREE

Lab Corporation of America, Raritan, New Jersey Aug 1995- Dec 1998

Department of Specimen Processing. Lab Technician

Ordered tests on patient samples as per doctors requests and reported the results.

Kept track of all incoming samples and was the liaison between the lab technicians and the doctors.

Confirmed all tests were taken conforming to cGMP compliance and investigated any obvious abnormal results or sample losses and complied the investigation in a report for management to review.

ADDITIONAL TRAINING

Midas Quality Management System, - Author, Reviewer/Approver Merck. West Point, Pennsylvania

Documentum – Author/ Reviewer/Approver, Sanofi Pasteur. Swiftwater, Pennsylvania

SAP, Sanofi Pasteur. Swiftwater, Pennsylvania

ISO 9000 FDA Compliance Testing Regulations, Sanofi Pasteur. Swiftwater, Pennsylvania

Trackwise, Sanofi Pasteur. Swiftwater, Pennsylvania

EDUCATION

Computer Technical Support, The Chubb Institute. New Brunswick, New Jersey

AutoCAD 14/2000/2004, Lockwood Greene Engineering, Somerset, New Jersey

Raritan Valley College, Raritan, New Jersey (Buisness)

United States Marine Corps, (Various LeadershipTraining And Team Building Responsibilities)

Contact this candidate