Demo

Senior Process Engineer

X4 Life Sciences
NH Full Time
POSTED ON 2/27/2025
AVAILABLE BEFORE 5/24/2025

Senior Process Engineer

A global biopharma company is seeking a Senior Process Engineer for their facility in New Hampshire. This role offers a comprehensive relocation package and involves supporting manufacturing operations, and equipment troubleshooting to ensure the smooth and continuous production of critical biopharmaceutical products.

Key Responsibilities :

  • Lead troubleshooting and corrective actions to resolve issues in manufacturing processes, ensuring uninterrupted product supply.
  • Serve as the system owner for manufacturing equipment and utilities, ensuring compliance with industry standards and maintaining lifecycle documentation.
  • Design, implement, and validate manufacturing systems, including facilities, utilities, and instrumentation from lab scale to full manufacturing scale.
  • Lead the development and execution of engineering documents, including specifications, user requirements, and qualification protocols.
  • Manage projects, including planning, resource allocation, budgeting, and timeline management for new equipment and systems.
  • Drive continuous process improvements, automation changes, and system upgrades to enhance manufacturing efficiency and reduce downtime.
  • Act as the technical point of contact during regulatory inspections and audits, ensuring compliance with cGMP, GEP, GAMP, and other regulatory standards.
  • Mentor and develop junior engineers while contributing to the strategic growth of the engineering team.

Qualifications :

  • Bachelor's or Master's degree in Engineering or a related life sciences discipline.
  • 8-10 years of experience in the pharmaceutical or biotechnology industry, with strong knowledge of process engineering in cGMP environments.
  • Expertise in GEP, GAMP, validation, and regulatory requirements in a biopharmaceutical setting.
  • Experience leading cross-functional teams, project management, and managing engineering life cycle documentation.
  • Strong analytical and problem-solving skills, with the ability to make independent decisions based on data and risk assessments.
  • Willingness to provide support outside of regular hours, including nights and weekends, as needed for manufacturing support.
  • If you're interested in this exciting opportunity or would like more information, please apply and reach out directly to o.archer@x4lifesciences.com .

    Will be great to run through the role in details with you!

    Alternatively, if you are not interested, but know someone who is, please share with them.

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