Manufacturing Engineer, 04402

Industry: Medical device, pharmaceutical, process improvements

Resides: Puerto Rico

Salary: Open

Relocate: Yes

On the Market:

RECRUIT

Career Profile

Pharmaceutical professional with 19 years of proven industrial in the manufacture and process development of solid dosage forms and medical device. Enjoys problem solving and seeing a project through to completion. Ability to lead and work a team toward achieving stated goals and objectives. Demonstrated capability to quickly gain a detailed understanding of a process in order to optimize efficiencies, reduce cost, and improve quality.



Employment

(Company), P.R.
Medical device Manufacturing Engineer
June 1999 to present


§       Responsible to provide process optimization and product enhancement support to all production area with in the heat seal facility. This included:
§       Technical support to manufacturing, extrusion during daily start-up.
§       Evaluate equipment failure to determine failure root cause by analysis and technical writing for manufacturing investigation. Coordinate investigational activities with the impact area and recommend corrective action plan to prevent future failures.
§       Coordinates equipment preventive maintance, instrumentation calibrations, equipment equalization and SOP/ SPEC'S updated.
§       Prepare training programs for validation equipment for new and updates.
§       Coordinate the execution of the validation process with manufacturing and other deparment.
§       Provide all technical on the troubleshooting of manufacturing and to the new and old equipment.
·       Performed validation activities such as preparering validation documentation (OQ,IQ and PQ) validation protocols.
§       Provide training on safety, validation techniques to technical operator.
§       Ensure that goals and objectives of projects are accomplished with in prescribed time frame and parameters.
§       Supervise 20 technical operators.

·       Support evaluation of plant technology capabilities to manufacture new products. 


  Merck Sharp & Dohme  Pharmaceuticals, Arecibo, P.R.
   Solid dosage Manufacturing Engineer
   October 1997 to June 1999.

·       Provide technical support and guidance in the development of process improvement and implementation of pharmaceutical manufacturing process on the solid dosage department.
§       Capsule area responsible for the compounding, granulation, pellet extrusion, drying, coating, encapsulation and capsules dryer.
§       Tablets area responsible for compounding, granulation, dryer, milling process, mixing process, compression, weight and harness test.
§       Provide technical expertise and troubleshooting to the area of responsibilities.
§       Investigate manufacturing deviation nature if it's related to procedures, equipment, supplier or other sources.
§       Follow the corrective action taken on the investigation, if there are implemented by due date.
§       Wrote deviation investigation report.
§       Participate on CGMP, FDA inspection.


·       Validate the manufacturing process; write documents (IQ,OQ.and PQ), executed validation studies according to the company requirements.
§       Conduct meeting with material supplierson validation issues. Assure GM P's and S.O.P'S standards and provide support to all manufacturing areas. 
§       Transfer of products, train recourses in transferred product process. 
§       Manage plan and directly overlooks implementation of necessary activities to accomplish successful transfer to plant.
§        Supervise 5 pharmaceuticals mechanics.
·       Development SOP's with in the plan to support strategic compliance initiatives, internal audit and manufacturing investigation report commitments.
·       Track documentation and prepare a summary status report.
·       Conduct training on SOP's and GMP.


United State Surgical Corp., Ponce, P.R
Medical Device Manufacturing Engineer
October 1990 to September 1997
       
·       Coordination of all the manufacturing / Packaging, assembly, activities for the Company's Project Program. 
§       These manufacturing projects included product transfer and the cost improvement program. 
§       Assure compliance with Sop's, ISO 9002 and Gmp's and troubleshooting, solving production and quality problems and identify, justify and implement process improvement & cost saving. 
§       Overall quality product and process improvements and maintain company standards.  
§       Responsible for the Start up and Validation Program of new products.
§       Coordinate product release and stability data prior transfer
§       Write and updates department SOP's.

·       Manage, plan and directly overlooks the implementation of necessary activities to accomplish successful technology transfers.
·       Review status report prepared by projects personnel.


IOLAB Pharmaceutical Inc. San Germān, P.R.
Parenterals Manufacturing / packaging Supervisor
July 1985 to September 1990

·       Provide direct supervision for approximately 30 manufacturing operator.
·       Responsible for the production activities of parenterals, Aseptic filling, Formulation, capsule and tablets.
§       Provide a unique environment of teamwork on a total quality management.  
§       Assure compliance with GMP'S maintains quality and productions standards. 
§       Develop and undated standard operational procedure. 
§       Responsible for the security, handling and reconciliation of product.
§       Ensure proper dispose of residue material.
§       Interacts with other department to address production issues.

·       Responsible for maintaining safe and efficient work environment by motivating personnel, conducting audits and conducting procedures assessments.
·       Provide necessary technical skill to bring process to a logical stop and recommended course of action to correct issues to prevent future occurrences.
·       Reviews of batch record and release them to distribution.
       

IOLAB Pharmaceutical Inc. San Germān, P.R.
 Quality Assurance Senior Technician
 September 1983 to July 1985

·       Under the direction of the Quality Assurance Manager, perform the in
coming in process and finished product release area and maintain up
Date batch record documentation for release.
·       Perform G.M.P. and internal F.D.A. Audit. 
·       Responsible for the field's complaint investigation.
§       Generate a complaint investigation form.
§       Assigned this complaint to Manufacturing Engineer, manufacturing supervisor, or if it was a quality Assurance issue investigated it completed the complaint report.
·       Develop and update standard operation procedures.
·       Deal with manufacturing and vendors production and Raw material issues.


Acknowledgements


·       1993-97 Transfer new product from U.S.S.C. Main Plant (Connecticut) to Puerto Rico facilities.

·       Reduction of on line Reject Scrap from 15% to 3% , this
           represent near $ 300,000 savings as cost reduction.

·       1988 Transfer the intraocular lenses manufacturing from San Lorenzo P.R
            to San Germān, P.R.

·       Transfer Quality Assurance procedures for the start up , from London, England
            to Puerto Rico facilities

Education

1983:  Bachelor Degree in Natural Sciences, Interamerican University,
San Germān, P.R
1990: Bachelor degree in Mechanical Engineering, Recinto Universitario de Mayaguez Puerto Rico

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