Quality Engineer-Pharm/Bio
Company: ILC Dover LP
Location: Frederica
Posted on: January 25, 2023
|
|
Job Description:
ILC Dover is a world leader in the innovative design and
production of engineered products employing high-performance
flexible materials. Since 1947, we have provided engineered
solutions to complex customer problems. Initially known for the
production of space suits for NASA, we leverage our vast materials,
engineering, process, and design experience to create high
performance systems for a wide range of industries. ILC Dover is a
portfolio company of New Mountain Capital, which acquired the
company in February 2020. Recognized globally for our flexible
containment solutions, ILC Dover serves customers in a diverse
range of industries, including pharmaceutical and biopharmaceutical
manufacturing, personal care, food and beverage, chemical,
aerospace, healthcare and government agencies. ILC Dover's
visionary solutions improve efficiency, safeguard workers and
product, and prevent disasters. For more information visit
ILCDover.com and follow us on LinkedIn.Job Summary: The PharmBio
business quality engineer actively supports pharmaceutical
containment manufacturing on a day to day basis. The quality
engineer would utilize their knowledge of ILC Dover quality systems
to drive compliance to ILC Dover, ISO 9001, and customer standards.
As part of these actions, they will identify continuous improvement
opportunities and participate in team activities that drives these
opportunities to closure. The quality engineer may also participate
in customer facing interactions such as audits, and customer
complaint responses.Successful candidates will have cGMP experience
in pharmaceutical and/or medical device manufacturing environments,
a data driven approach, and a willingness to work together as a
team.This is an on-site floor support position. Commuting or
relocation to the Frederica, DE location will be necessary. Typical
hours are 8 am - 4:30 pm M - F. *Essential Job Duties:Design and
implement audits and control plans for products to ensure product
quality targets are metEstablish, define, implement, maintain, and
report on quality assurance key performance measures and
standardsInvestigate non-conformances and consumer complaints, lead
completion of root cause analysis, implement corrective actions,
and monitor progress and improvementsDrive continuous improvement
on quality standards, requirements, and best practicesCreate and
maintain quality systems documentation, such as quality manuals,
procedures, and work instructions Devises sampling procedures and
designs and develops forms and instructions for recording,
evaluating, and reporting quality and reliability dataApplies
statistical process control (SPC) methods for analyzing data to
evaluate the current process and process changesPrepares and
presents technical and program information to team members and
managementDirects technical and administrative workers engaged in
quality activitiesMaintains a working knowledge of government and
industry quality codes and standards including ISO 9001.*This job
description is not designed to cover or contain a comprehensive
listing of activities, duties or responsibilities that are required
of the employee. Other duties, responsibilities and activities may
change or be assigned at any time with or without notice.
AssociateEntry-Level position within fieldConducts routine tasks as
directedContributes to specific objectives and outcomes as
directedClosely supervised with little latitude for independent
judgmentWorks under clearly defined guidelines Qualifications:Must
be able to access shared database with government programs (U.S.
Citizen or Permanent Resident of the U.S.)Bachelor of Science
degree in Engineering or other STEM field of studyExperience in
CAPA, root cause analysis and 8DSix Sigma Green Belt or Black
Belt.Experience in a clean room environment (Preferred)ISO 9001
Internal auditor (Preferred)Proficient with word processing
software; statistical analysis software (SPC); graphics software;
order processing software, and database softwareProficient with
measurement, calibration, and test equipment Work Environment: The
work environment characteristics described here are representative
of those an employee encounters while performing the essential
functions of this job. Reasonable accommodations may be made to
enable individuals with disabilities to perform the essential
functions. While performing the duties of this job, the employee is
frequently exposed to work near movingmechanical parts. The
employee is occasionally exposed to fumes or airborne particles.The
noise level in the work environment is usually moderate. Physical
Demands: The physical demands described here are representative of
those that must be met by an employee to successfully perform the
essential functions of this job. Reasonable accommodations may be
made to enable individuals with disabilities to perform the
essential functions. The employee must regularly lift and /or move
up to 10 pounds, frequently lift and/or move up to25 pounds and
occasionally lift and/or move up to 50 pounds. Specific vision
abilities requiredby this job include Close vision, Color vision,
Distance vision and Depth perception. Whileperforming the duties of
this Job, the employee is regularly required to walk and talk or
hear.The employee is frequently required to stand; use hands to
finger, handle, or feel and reach withhands and arms. The employee
is occasionally required to sit; stoop, kneel, crouch, or crawl
andtaste or smell.As an Equal Opportunity Employer, ILC Dover is
committed to a diverse workforce. We offer competitive benefits
including medical, dental, life insurance, 401(k), PTO, and more.
Background Check & Drug Screening RequiredE-Verify UsedEOE/AA
Minority/Female/Sexual Orientation/Gender
Identity/Disability/Veteran PI202023113
Keywords: ILC Dover LP, Wilmington , Quality Engineer-Pharm/Bio, Engineering , Frederica, Delaware
Click
here to apply!
|