Maintenance Engineer

William R. Bienish, Jr.

Montgomery, NY

*****

Phone: 845-***-****

Email:

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

Summary

Sr. Associate Process Engineer with

extensive knowledge in Pharmaceutical Industry provides day

to day direction to maintenance employees and contractors

on all aspects of maintenance work throughout the plant,

including the maintenance, repair and upkeep of production

equipment, infrastructure and utilities. Accountable for

supervising resources to ensure that the work performed by

maintenance staff is accurate, timely, efficient and

compliant with corporate policies, plant SOPs, c GMP

regulations and FDA regulations.

Work Experience:

11/12 - Present

Sr. Assoc. Process Engineer

. Serve as a technical representative

for process-related issues at the facility.

. Work with manufacturing to

meet the production schedule, ensure commercial supply and

uphold quality standards.

. Performing monitoring of

critical quality attributes/critical process parameters to

maintain product quality and to control process drift.

. Identifying and implementing

potential process improvements.

. Supporting manufacturing and

quality during regulatory inspections and for critical

investigations where scientific or technical assessments

are required.

. Assist in documenting

changes/updates to manufacturing processes and working with

manufacturing, engineering and validation to implement

those changes.

. Reviewing and provide

feedback and technical/scientific support on project

deliverables, i.e. remediation initiatives, plan reports,

etc.

2/10 - 11/12 Pfizer

Senior Operations Specialist / Production

Supervisor

. Accountability - support counseling program regarding

Human errors. Counseling is completed in a timely fashion

. Support Human Error Reduction effort at site

. Recognize efforts that eliminate waste and simplify our

work

. Build our individual skills and expand our collective

capabilities

. Active engagement in PBL(Process Based Leadership),

familiarity with PBL handbook, engage hourlies in data

and information from PBL

. Continue to build business acumen at the operator level

through the use of PBL. Keep hourly staff informed of

RFT, OSR, OEE, losses and other metrics in PBL.

. Schedule personnel and coordinate scheduling of

production

1/03 - 2/10 Pfizer

Pearl River, NY

Maintenance Supervisor

. Schedule, plan and coordinate

maintenance work to be done, including calibration, work

requests and PMOs' to ensure that all equipment and

facilities are cGMP compliant and are running efficiently

and safely. Prioritize work and then schedule and assign

appropriate personnel to complete the work. Coordinate with

manufacturing departments' to release the equipment for

service. Arrange shutdowns as needed.

. Trained and lead maintenance

personnel in repairs and troubleshooting of aseptic filling

and packaging equipment, to include Inova, Bosch, Eisai and

Uhlmann equipment.

. Maintain work order backlog and

maintenance records to ensure that all work requests and

PMOs' are issued, prioritized, assigned, and approved as

complete and closed out.

. Worked with automation group to

troubleshoot PLC and VFD issues.

. Troubleshoot equipment issues and

helped reduce downtime by 50 % thru training and PMO

revision.

. Experience in facilities

maintenance to include HVAC systems and BMS systems.

. Purchase tools, parts, supplies for

maintenance using computerized maintenance systems and

maintain / inspect inventory of critical parts. Involved

completing purchase request, obtaining quotes from venders,

converting to a purchase order and sending for approval.

. Supervise hourly personnel,

including contractors, to ensure that they are performing

their work efficiently and in a safe compliant manner.

. Experience with Maximo / SAP / SRM

/ Track wise / MS Excel

And Word.

. Managed contractor purchase orders

and kept all work within budget.

08/99 - 1/03 Wyeth (acquired by Pfizer)

Pearl River, NY

Set - Up / Line Mechanic

. Operate, maintain, repair and troubleshoot

production equipment in sterile filling environment and

on packaging lines.

. Responsible for equipment changeovers and

efficiency.

. Adhere to company SOPs' and cGMP guidelines.

. Reading of schematics and wiring diagrams', use of

tools, meters, test equipment, calipers and micrometer.

. Follow Q/C and Q/A limitations and guidelines.

. Operate, maintain and monitor WFI system to include

building systems.

. Promoted to supervisor.

Education: U.S. Army Basic Training

U.S. Army Aviation Center

Baccalaureate Degree thru military

Service.

1 Semester College

Accomplishments: Army Achievement Medal

Letter of Appreciation

Continuous Improve Award

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