JOB OFFER: Quality Engineer - BioTech - Indianapolis

Internet Recruiter cbarrus at
Tue Aug 21 16:23:06 EST 2001

Quality Engineer - BioTech
Location: Indianapolis, IN United States 


There are multiple Quality Engineer positions available. These
positions will support development, manufacturing operations and
facilities in Indianapolis, IN. The manufacturing operations are for
the Dry Products Site, Parenteral Site and Bulk Operations. The Dry
Site manufactures and packages pharmaceutical products such as
liquids, ointments, capsules and tablets. The Parenteral Site
manufactures and packages injectable pharmaceutical products such as
insulin and those administered intravenously in hospitals. The Bulk
Operations is dedicated to large-scale biotech production. These
positions also support development operations and facilities, which
may consist of labs or pilot plants.

We are looking for people with strong technical backgrounds in the
field of engineering with knowledge and understanding of FDA or other
quality regulations. The profiles we are seeking are people with work
experience as a process/manufacturing engineer, process
control/automation engineer or facility/utility engineer.

Depending on your background, you will be focused on supporting day to
day responsibilities in one of the above arenas. As a Quality Engineer
you will be responsible for providing technical guidance and
leadership on quality standards employed to maintain and improve
development and manufacturing operations and facilities.

Job Responsibilities

Ensure facilities, utilities, systems and equipment are designed,
installed, and maintained to be compliant with cGMP.
Consult with engineering and maintenance personnel to ensure
production, facility, and utility equipment and systems are maintained
and corrected in compliance with cGMP.
Support improvement initiatives and ensure necessary change
documentation is completed. Understand the potential implications of
the change and methods to verify a successful change.
Understand and utilize required documentation such as change
documentation, installation qualification, operational qualification
performance qualification (IQ/OQ/PQ) documentation; preventive,
predictive and corrective maintenance plans, validation documentation
and standard operating procedures.
Provide leadership for inspection readiness activities and ensure a
constant state or inspection readiness.

If your focus is day to day:

Manufacturing operations, you will consult with production and
production support personnel to troubleshoot and correct daily
production issues.
Control/automation equipment and systems you will be involved in
computer system validation efforts.
Facilities/utility systems you will be responsible for operation,
maintenance and improvement of nitrogen, water, HVAC, air handling
systems, etc.


BS Engineering discipline or equivalent degree.
Experience with FDA or other quality regulations (experience in FDA
regulated industry preferred).
Experience as a process/manufacturing engineer, process/control
automation engineer or facility/utility engineer.

**** Please reference job number EL56512 when emailing your resume to
cbarrus at  We look forward to assisting you in your job
You can view all our open positions at **** 

                Volt is an Equal Opportunity Employer.

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