job_080511a: cGMP Plant Engineer: Bend Research (Bend OR)

From: Kristin Burns <kristin.burns_at_stanford.edu>
Date: Fri, 05 Aug 2011 12:19:55 -0700

Bend Research Inc., a growing multidisciplinary contract research,
development and manufacturing company specializing in improving
health, is seeking a cGMP Plant Engineer at its current Good
Manufacturing Practice (cGMP) facility. Candidates should have 5-7
years of work experience in a pharmaceutical operations or
engineering setting. A Bachelors Degree in Mechanical or Chemical
Engineering is preferred. A successful candidate will be able to
demonstrate understanding of pharmaceutical equipment, operation and
process in production of bulk intermediate and solid dosage forms.
Must have the capability to statistically monitor and analyze
processes to determine deviation from specification and optimize
output. An ability to design, specify, procure, implement and qualify
process equipment and facilities to Good Manufacturing Practices
(GMP) standards is required. Must be familiar with pharmaceutical
technical transfer processes and process automation. An ability to
manage projects in support of defined business goals is a required.
Key responsibilities include:

    * Responsible for technical assessment, implementation,
monitoring and control of pharmaceutical process systems focused on
safety, reliability, maintainability and yield.
    * Evaluate unit operation regarding:
o Safety: Conduct HAZOP and Job Safety Analysis; Evaluation
procedure and adherence; define system enhancements working with
Manufacturing, Quality, Engineering and Development.
o Reliability: Evaluate current maintenance tasks; conducting
Failure Mode and Effects Analysis (FMEA); Identify predictive
maintenance procedures.
o Maintainability: Evaluate existing configuration and operational
methods are consistent with OEM and Development Engineering
recommendations, to make robust our ability to adequately maintain
equipment on a timely basis
o Yield: Drive continuous improvement efforts which result in
consistent and increased yields and or reduces probability of batch
failure based on electro-mechanical workings of the process and
support equipment
    * Directly support validation, revalidation and change control processes.
    * Acts as Safety Officer, driving compliance with existing
program while implementing enhancements tied to best practice and
industry standards.
    * Coordinate with maintenance and Manufacturing teams, supporting
development of a robust predicative maintenance program.
    * Support Quality Investigations by conducting the technical
evaluation of the systems and providing data and supporting
documentation driving to root cause.

Bend Research is located in Bend (population 80,000) in Central
Oregon, the premier recreational area in the Northwest. Bend is a
sunny High Desert community located on the eastern slope of the
Cascade Mountains near Mount Bachelor ski resort, world class
fly-fishing and golf, and other outdoor amenities.

Bend Research is an equal opportunity/affirmative action employer.

Bend Research offers competitive salaries and benefits, as well as
excellent opportunities for growth. In your cover letter, please
include how you learned about this position. Send your cover letter,
resume, and list of three professional references with telephone
numbers to Human Resources at

Bend Research Inc.
64550 Research Road, Bend, OR 97701-8559
E-Mail: hr_at_bendresearch.com




Disclaimer - August 5, 2011

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Received on 2011-08-05 12:19:22

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