Lew Allen forwarded the following job opening description. For further info, please contact Anderson Resources (contact info below). - Jim
Job Opening
*Sr. Facilities Engineer*
(Rochester, NY)
Provides Rochester Operations engineering support of facilities
services required for use in a GMP medical device manufacturing
operation including but not limited to purified water, compressed
air, HVAC, nitrogen, IPA, buildings & layouts and other services as
required. Both independently and in conjunction with support
departments uses data analysis tools to identify, analyze, recommend
and support the implementation of continuous improvements to improve
facility services, performance, operating costs, customer service,
business processes, and reaction time to interruptions of
manufacturing processes related to but not limited to these
services. Manages and/or executes the completion of major projects
and validation activities in accordance with all QSR and ISO
regulations. Maintains timely compliance to GMP, ISO, EH&S, and all
other functional related regulations required of medical device
manufacturing per global and plant SOP?s. Required to manage capital
expenditure projects to completion that will involve initial
financial analysis, project estimating, CER development and CER
spend control. Provides technical direction in a supervisory
leadership role as needed for levels of maintenance and engineering
activities and resources assigned to a continuously operational
medical device manufacturing process on a 7x24 basis.
Specific knowledge REQUIRED in purified water systems that produce
certified USP grade water for medical device manufacturing.
Responsible for managing all applicable compliance systems related
to the purified water system including but not limited to:
maintenance, change control, testing, data analysis and trending,
unexpected events, end user point compliance, documentation, SOP?s
and compliance with FDA-GMP regulations. Have the skills and
abilities to monitor and adjust the purified water treatment
processes to ensure the water supply complies with the user?s
requirements. REQUIRED to manage the installation and validation of
a new purified water system and managing the redesign of
manufacturing loops and end use points for compliance.
*_Qualifications:
_*Four year technical degree REQUIRED in field such as, but not
limited to, electrical or mechanical engineering or chemical
engineering.
A certification in purified water generation and distribution
systems is desired.
Training in cGMP along with a minimum four years of medical device
manufacturing experience REQUIRED, demonstrating a progression of
skills in facility services and principles and practices of
engineering project management.
The ideal candidate will have a minimum two years of responsible
experience in principles and practices of engineering as applied to
purified water systems, conducting purified water quality and
environmental studies, data analysis, operations management,
validations and experience with understanding local codes and
regulations required of such systems.
Detailed understanding of electrical, mechanical, and architectural
schematics required. Validation experience REQUIRED.
Experience must include executing to a validation strategy including
protocol generation, test execution, and final report generation.
Green belt or black belt certifications in Six Sigma applications
and LEAN tools preferred. Principles and practices of leadership and
supervision of technical resources.
Computer programs, languages and their engineering applications.
*_Must Have:_*
USP water systems experience
Pharmaceutical or electronics manufacturing experience
Facilities engineering experience.
Experience supporting a 7x24 operation in a controlled environment
Send resume to:
Anderson Resources
andersonresources@yahoo.com <mailto:andersonresources@yahoo.com>
585-381-7738