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
      
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Keywords: ILC Dover LP, Wilmington , Quality Engineer-Pharm/Bio, Engineering , Frederica, Delaware