Post Job Free
Sign in

Training Operator

Location:
Wayne, PA
Posted:
March 19, 2014

Contact this candidate

Resume:

Jeffrey M Lawrence

Date Revised: **\**\**

Your Name

Address, phone, fax, email

Production Supervisor

Profile

Production Supervisor, Johnson Matthey Pharma Services, 02/14/00 –

Experience Present

Responsible for planning and all daily operations associated with our

Large-Scale Purification process. This includes setting the operator

schedule and any resolution that is required to the schedule.

Provide on the floor training to support formalized technical and GMP training.

Check that operator training files match and support the processes they are

required to carry out, and provide continued motivational and team building

atmosphere. Help management to provide a path for operators and school them

to advancement.

Purification of Pharmaceutical API’s by use of Large-Scale Purification

columns varying in size from 30cm to 100cm (I.D.).

Monitor operator training files and work with compliance specialist to keep

files up to date.

Review, on a shift wide basis, the batch records for error and deviations,

signing off responsibility to the next supervisor after this review.

Lead purification process and perform real-time analysis of the

operation while running. This would include making the decision on

fraction collection scheme based on in-line UV trace display and typical

subunit peak purity profile based off of research of previous campaigns if

available. Often it is necessary to change operating parameters, such as

flow rate or elution scheme, which I direct the team if required.

Assist in scale-up of all processes to maximize loading capacity and

yield capabilities in order accomplish the most efficient operation.

Packing and un-packing of columns used for purification prior to use for

processes or to ready columns for cleaning prior to new process.

Perform routine maintenance on column and all associated parts such

as seals, frits, valves and all other process dedicated equipment. This

includes pumps, flow-control meters and valves, UV flow cells and Thin-

Film Evaporators that are used in concentration of product that meets

target specifications.

Maintain and order all required components of purification columns. I

was able to find alternative suppliers for many of the O-rings, gaskets

and Teflon seals that are necessary for column production. By doing this

I was able to generate an annual savings of ~ $68,000 on frequently

replaced components for our 100cm Column. This savings will also be

able to be applied to our other columns going forward.

Order and maintain required solvents for production. This includes

receiving said solvents into our inventory system and dispensing out of

the inventory system once it is consumed.

Order replacement parts for process equipment from suppliers when

needed, or research to find a supplier for whatever parts are needed.

Purchase the required parts through the company purchasing system.

Write and revise documentation such as SOP’s as needed to ensure

cGMP manufacturing practices are being followed, or create an SOP if

the procedure is new or if a new piece of equipment is being

implemented to an operation.

Train all staff on operation and safety related SOP’s and

documentation, as well as perform refresher training on all

documentation as needed.

Revise or create Batch Records, which are the written procedures that

are followed during production.

Assist in validation\qualification of any new equipment that is to be

introduced to the process, and any new procedures that are developed.

Manage all troubleshooting on equipment and process while in

operation as well as during off hours.

Assist in yearly calibrations of process equipment.

Chem Design Corp. Fitchburg, Ma. 01420

Chemical Operator: 06/1992 02/2000

Manufacturing of custom and quality chemicals used in various

industries for many different applications.

Combining of various chemicals, both solvents and acids, in order to

achieve the desired fusion of chemical compounds and produce the

desired product.

Precise weighing and transferring of compounds into various sized

reactors that were either stainlesssteel or glasslined, depending on the

physical properties of the particular compound.

Once in the reactor it was my responsibility to perform extreme

exothermic or endothermic reactions by use of several different heating

and cooling methods, such as hot oil, steam and glycol cooling systems.

Perform general maintenance work on the process equipment.

Your Name

Address, phone, fax, email

Member of the Emergency Response Team, as well as Asst. Lead

Operator.

Education:

Mount Wachusett Community College Gardner, Ma.

Years Attended 1990 1992

Associate Degree Criminal Justice

ERT Member, Fork truck Certified

Training &

Certificat

ions

Your Name

Address, phone, fax, email



Contact this candidate