Quality Engineer-Pharm/Bio
Company: ILC Dover LP
Location: Frederica
Posted on: January 27, 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 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 met
- Establish, define, implement, maintain, and report on quality
assurance key performance measures and standards
- Investigate non-conformances and consumer complaints, lead
completion of root cause analysis, implement corrective actions,
and monitor progress and improvements
- Drive continuous improvement on quality standards,
requirements, and best practices
- Create 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 data
- Applies statistical process control (SPC) methods for analyzing
data to evaluate the current process and process changes
- Prepares and presents technical and program information to team
members and management
- Directs technical and administrative workers engaged in quality
activities
- Maintains 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. Associate
- Entry-Level position within field
- Conducts routine tasks as directed
- Contributes to specific objectives and outcomes as
directed
- Closely supervised with little latitude for independent
judgment
- Works 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 study
- Experience in CAPA, root cause analysis and 8D
- Six 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 software
- Proficient 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
PI
Keywords: ILC Dover LP, Wilmington , Quality Engineer-Pharm/Bio, Engineering , Frederica, Delaware
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