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Process Engineer

2 months ago

Gaithersburg, Maryland, United States Actalent Full time
Job Title: Process Engineer

We are seeking a highly skilled Process Engineer to join our team at Actalent. As a Process Engineer, you will play a critical role in the design, optimization, and implementation of manufacturing and laboratory equipment.

Key Responsibilities:
  • Design and optimize process flow diagrams, risk assessments, and asset standardization.
  • Support the evaluation, selection, and recommendation of process and laboratory equipment that meet quality and regulatory compliance requirements.
  • Develop and maintain OEM files, including equipment turnover packages, O&M manuals, and drawings.
  • Perform front-end loading (FEL) and feasibility studies of equipment used in GMP and cGLP applications.
  • Troubleshoot process issues during startup of new and existing facilities and process/laboratory equipment.
  • Analyze and upgrade process and utility systems as needed.
  • Implement problem-solving skills and techniques to identify potential issues and develop mitigation and resolution plans.
  • Ensure compliance with company procedures and statutory requirements (US FDA and ISO).
Requirements:
  • Bachelor's degree in Chemical Engineering or related field with 2-4 years of experience in process design and construction.
  • Experience in a manufacturing plant environment, preferably in the biotechnology or pharmaceutical industries.
  • Auto Desk Fusion 360 or SolidWorks experience preferred.
  • Strong process/laboratory equipment technical problem-solving abilities.
  • Experience with automation systems and cGMP Quality Systems in a biotech/pharmaceutical environment.
About Actalent:

Actalent is a global leader in engineering and sciences services and talent solutions. We help visionary companies advance their engineering and science initiatives through access to specialized experts who drive scale, innovation, and speed to market.

We are an equal opportunity employer and welcome applications from diverse candidates. If you require a reasonable accommodation, please email [insert email].