Manufacturing Engineer

Lawrence Bonk

***** *. ******* *** **.

Tucson, Az. 85739

Cellular 1-520-***-****

******@*****.***

Summary

Over 20 years Quality Assurance/Manufacturing experience in the Pharmaceutical Industry.

Knowledgeable in commercial and research and development manufacturing. Experienced in

GMP, Non-GMP, and GLP. Tireless work ethic. Committed to project completion. Work well

under pressure during fast paced and stressful situations. Effective communicator, both oral and

written.

Experience

Self Employed – Restaurant (Bonkers on Main), Libertyville, Illinois 2010 to 2012

Owned and operated a restaurant.

•Responsible for hiring, training, and supervising personnel.

•Budgeting, forecasting and inventory control.

•Responsible for profit and loss

•Used computer applications to track sales, and other information.

•Proficiency within critical thinking and problem solving and new product launch.

•Responsible for training staff on food handling safety.

Abbott Laboratories, North Chicago, Illinois 2000 to 2010

Quality Engineer

Manufacturing professional with experience as a Quality Engineer in commercial and research &

development manufacturing, and Analytical Labs.

•Supervised a BRR (Batch Record Reviewer) for 4 years. Developed a BRR test to qualify

individuals to reviewed batch records.

•Managed file room where batch records were stored, prior to going to corporate records,

•Responsible for the release of active pharmaceutical ingredients (API) and Drug Product to be

used in Commercial, clinical studies, and toxicology uses (Non-GMP).

•Supported the Analytical Labs

•Wrote manufacturing instructions and Standard Operating Procedures (SOP's).

•Reviewed/Approved IQ/OQ/PQ Validation Packages for Process Equipment and Process

Cleaning, and CIP (Cleaning in Place)

•Member of the VRB (Validation Review Board)

•Generated schedules for Annual Product Review (APR). Compiled supporting documents for the

data file and the executive summary of the APR. Performed product review for the APR.

•Performed internal audits, wrote observations, and assisted with and approved corrective

actions.

•Performed Supplier Audits to assure compliance.

•Prepared area for internal/Third Party/Government audits. By doing walkthroughs, and review of

documentation. Served as the lead contact in the front room by directing

questions/observations to the appropriate contacts and coaching these individuals prior to

entering the front room. No major observations were written during these audits.

•Took on lead role in bringing a non-GMP lab for radio-active material to GMP standards to

manufacture active pharmaceutical ingredients (API) for clinical studies. Wrote manufacturing

instructions, Standard Operating Procedures (SOP's), performed internal audit, and approved

materials for use in first lot. Worked on floor during processing of first lot to achieve a

successful delivery.

•Developed metrics to track CAPA (corrective action preventative actions), investigations,

deviations, microbial outages and CAPA timeliness. Which reduce microbial outages,

reduction/avoidance in audit observations, CAPA tardiness. Reported metrics monthly and

quarterly to upper management.

•Approved/wrote (Lab & Manufacturing)Investigations, Microbial Outage Investigations,

Deviations, Corrective Actions, and Preventative Actions. Performed Gap Analysis when

necessary.

•Approved/reviewed manufacturing instructions, 240 yearly average, prior to being released to

being released to the manufacturing area.

•Investigated customer complaints/recalls.

•Approved incoming materials, 450 yearly average, before use in the manufacturing areas for

timely start ups.

Abbott Laboratories, North Chicago, Illinois 1998 to 2000

Shift Supervisor

Manufacturing professional with experience as a Supervisor in commercial and research &

development manufacturing.

Shift Supervisor at the Chemical Pilot Plant.

•Supervised 24 Chemical Operators on a rotating shift basis on all aspects of production to

ensure timely release of product.

•Wrote performance evaluations and goals for the Chemical Operators.

•Defined and wrote Standard Operating Procedures(SOP's).

•Responsible for investigating MEC(Microbial Environment Control) outages

•Responsible for cleaning validation and CIP(Cleaning in Place)

•Conducted/wrote investigations for nonconformances.

•Performed validation activities on new process equipment

•Took a successful lead role on a project team to increase Propofol production by 5 times with

capacity limitations to meet customer demands.

•Tracked OSHA incidents and develop preventative action plans.

Abbott Laboratories, North Chicago, Illinois 1989 to 1998

Group Leader

Supervised 8 Chemical Operators in a Commercial Chemical Facility in all aspects of production

to meet product demands.

•Supervisor of two Class 100 manufacturing facilities. Bovine Lung Lipids (Survanta) and

Leuprolide (Lupron).

•Wrote performance evaluations and goals for the Chemical Operators.

•Performed/wrote investigations for nonconformances.

•Defined and wrote Standard Operating Procedures (SOP's).

•Worked in Chromatography Manufacturing Area (Lupron), and performed in-process HPLC's

and TLC's tests.

•Developed a Quality walk-through list for operators.

Certificates

Concordia University, Mequon, Wisconsin 2001

B.A. Communication

American Society of Quality 2005

ASQ certified Auditor

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