Process Quality Engineer (Elgin)

Akorn in Elgin, IL

  • Industry: Engineering - Civil Engineer
  • Type: Full Time
  • $91,430.00 - 129,700.00
position filled

SUMMARY:

Responsible for designing processes and improving current practices to meet the needs of product development efforts within the Akorn organization. This professional will be responsible to understand cGMP, and other FDA Guidance Documents, as well as the current processes and practices that are current and ongoing at the Decatur manufacturing/packaging sites.

ESSENTIAL FUNCTIONS:

The duties include providing a strong technical base with a vision of product development, new product transfers, etc. The following is not intended to be an all inclusive list of job activities, but rather a description of duties and/or functions that will be closely related to the job.

  • Support the Engineering and Maintenance functions through work order approval, general equipment knowledge, and Change Control management, in order to support equipment, system and facility modifications and upgrades for automated process efficiency, regulatory compliance and replacement of obsolete equipment, controls and systems.
  • Demonstrate technical knowledge to write and/or review detailed equipment / facility / system specifications in relation to process control systems and related technology. Support Regulatory Affairs with technical writing as pertaining to equipment and processes for product submissions.
  • Provide leadership and quality oversight for continuing process improvement efforts for both Production and Engineering. This shall include the review of Capital Projects which benefit the line efficiency and/or productivity.
  • Must have the ability to read and understand Technical Transfer Documents and assist in writing the associated Master Batch Records and/or other technical documents that will complete the transfer of information required for manufacturing product. The incumbent must be capable of properly assigning equipment use, area for manufacture, and preferred methods. Must work closely with Operations Management in order to create a successful product transfer.
  • Must be willing to work with regulatory agencies as required, including but not limited to the Food and Drug Administration (FDA), Drug Enforcement Agency (DEA), and Occupational Health and Safety Administration (OSHA).



  • ADDITIONAL RESPONSIBILITIES:
    Additional responsibilities may include assisting with validation activities associated with equipment and/or processes. The job may require travel to vendor sites to complete Factory Acceptance Testing in order to accept equipment for the site. Expected travel of less than 10%.

    Qualifications

    QUALIFICATIONS:
    To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed are representative of the knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

    EDUCATION AND/OREXPERIENCE:

    Bachelors degree in Engineering or related field required. Minimum of 5 years related experience and 4 years process engineering experience in a Pharmaceutical operation is preferred.

    JOB PREREQUISITES:
    Ability to meet attendance standards. All full-time employees are required to work a 40-hr week. At times it may be necessary to work additional hours in order to get the required tasks accomplished to meet deadlines.

    Proficient in Microsoft Word, Excel, Project and CAD system and PLC control system working knowledge.


    PHYSICAL DEMANDS, MENTAL REQUIREMENTS, AND WORK ENVIRONMENT:
    The position requires prolonged sitting. Requires eye-hand coordination and manual dexterity to operate keyboard, photocopier, telephone, calculator and other office equipment. Occasional high stress work requires dealing with customers/clients and regulatory agencies. May have exposure to hazardous chemicals.

    Mental Requirements include:
    Ability to hear accurately the spoken word with moderate office noise or plant noise
    Ability to apply deductive reasoning and understand complicated issues
    Ability to receive instructions and follow work rules and company policies
    Ability to follow safety and security practices
    Ability to meet deadlines and effectively deal with office stress
    Ability to accurately communicate ideas, facts and technical information
    Maintain confidentiality of certain information


    Associated topics: building code, department of transportation, draw, infrastructure, land, microstation, remedial, remediation, road, structural analysis

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