Instrumentation Laboratory Company

Process Development Engineer II

Pharmaceuticals & Biotech
Less than 5 years of experience
Job Overview by Ladders

Qualifications

  • B.S. in Engineering required
  • Minimum 2 years related experience
  • Familiarity with Installation Qualification (IQ), Operational Qualification (OQ), Performance Qualification (PQ)
  • Ability to understand risk documents such as pFMEAs
  • Proven technical judgment and autonomy in engineering tasks

Responsibilities

  • Perform validation activities including IQ, OQ, and PQ
  • Analyze process data to identify trends and assess capability
  • Design and develop moderately complex components and circuits
  • Provide technical direction and supervision to support staff
  • Independently execute engineering tasks under minimal supervision
  • Prepare specifications and maintain accurate engineering documentation
  • Test materials for compliance with technical specifications

Benefits

  • Medical, dental, and vision insurance
  • 401k plan with employer match
  • Paid vacation and sick leave
  • Eligible for performance-based bonus in select roles
Full Job Description
Overview

Position Summary:

Using company procedures, quality system requirements, and engineering best practices, performs process development, characterization, and validation activities in support of new product introduction (NPI) and platform-based initiatives. Independently plans and executes process characterization studies, process optimization efforts, and qualification protocols, including Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ). Analyzes process data to identify trends, assess process capability, and drive continuous improvement. Collaborates with cross-functional teams to support the development and implementation of new designs and platform technologies as identified by program leadership. Operates with a high degree of technical judgment and autonomy while ensuring compliance with applicable quality and regulatory requirements.

Responsibilities
• Ability to perform validation activities, including but not limited to Installation Qualification (IQ), Operational Qualification (OQ), Performance Qualification (PQ), and evaluation of process operating conditions.
• Ability to perform validation activities, including but not limited to understanding risk documents such as pFMEAs.
• Performs varied engineering assignments under minimum of direct supervision and technical guidance.
• Technical responsibilities directed to engineering assignments which substantially add to the program.
• Designs and develops moderately complex parts, components, and/or circuits.
• Provides technical direction to support personnel as directed by engineering supervisor.
• Accomplishes independent designs, analyses, and interpretations of engineering data.
• May test materials for adherence to technical specifications.
• Prepares specifications for developed parts, components, and/or circuits.
• Maintains a good engineering notebook.
• Provides limited technical guidance to other engineers and supervision to technicians assigned to projects.
• Performs other duties as requested

Qualifications

Min Knowledge & Experience required for the position:
  • B.S. in Engineering and a minimum of 2 years experience related to the areas given above or suitable equivalent combination of education and experience.


International Mobility: Required: no

Travel requirements:

    The annual base salary range for this role is currently $80K to $100K. Individual employee compensation will ultimately depend on factors including education, relevant experience, skillset, knowledge, and particular business needs.

    This role is eligible for medical, dental, and vision insurance, 401k plan retirement benefits with an employer match, as well as paid vacation and sick leave. Our sales roles are eligible for participation in a commission plan and our management, and select professional roles, are eligible for a performance-based bonus.

    About Instrumentation Laboratory Company

    Instrumentation Laboratory Company (IL) is a global leader in the development, manufacturing and distribution of diagnostic solutions for Acute Care Diagnostics, with a focus on Critical Care and Hemostasis testing. Our success comes from a specific focus in these rapidly evolving diagnostic areas, our commitment to customers, and our dedication to innovation and quality. IL develops, manufactures and distributes diagnostic solutions including: critical care systems, hemostasis systems and information management systems. IL's products are used in hospitals around the world, including large hospital systems, independent hospitals and clinics, and reference laboratories. IL is headquartered in Bedford, Massachusetts, and has operations in Europe, the Middle East, Africa, Asia-Pacific, and Latin America.
    Learn more about Instrumentation Laboratory Company
    Size
    1,000 employees
    Industry
    Net Income
    $50 million
    5 Year Trend
    +5%
    Revenue
    $500 million

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