Process Engineer

About the role

The Process Engineer will provide technical support for GMP drug product manufacturing operations. This role will provide technical support and conduct investigations into product/process quality events and customer complaints; identify, assess, and execute projects to optimize existing processes, raw materials, components, and packaging in manufacturing and final product packaging; work with multi-functional teams to execute and deliver assigned projects, including specification, conceptual development, protocol writing, selection, testing, and qualification.

Responsibilities

• Evaluate opportunities to improve quality, efficiency, and customer service through changes to product components, component processing, and component inspection.
• Evaluate opportunities and present projects to management for approval to implement changes.
• Work with multi-functional teams to execute product and packaging projects to improve and optimize manufacturing and packaging processes.
• Support complex projects to meet established timelines without impacting manufacturing.
• Proactively adjust schedules to meet changing priorities.
• Provide technical support for the transfer of new or improved manufacturing processes between functional groups or sites, ensuring knowledge capture and compliance with quality and regulatory standards.
• Write and execute validation protocols either acting as the study director/validation engineer or working with the Validation department.
• Lead and participate in investigations to drive technically and scientifically sound corrective and preventative actions.
• Investigate product complaints and write reports of investigations.
• Assist as required to support conclusion and possible corrective actions.
• Develop, review, and maintain various radiopharmaceutical and cGMP documents, including Standard Operating Procedures (SOPs), Batch Records, Work Instructions and technical documents.
• Develop and conduct training materials for target audiences on document updates, ensuring full compliance.
• Present data and information as a technical subject matter expert to regulatory agencies.
• Advocate for safety, demonstrating good safety practices including the appropriate use of protective equipment.
• Report and take initiative to correct safety & environmental hazards.
• Manage change controls in Quality Management System (QMS) as applicable for tech transfers.
• Stay updated with industry regulations and guidelines (e.g., FDA, EMA) to ensure all documentation meets regulatory requirements and contributes to regulatory submissions.

  Requirements

  • Bachelor’s Degree in Engineering or related scientific discipline.
  • Minimum 2 years of experience in pharmaceutical or medical device manufacturing or other related regulated industry.
  • Expert knowledge of MS Office suite.
  • Previous experience working with radiopharmaceuticals and CMOs strongly preferred.
  • Direct experience with project management skills.
  • Excellent organizational and time management skills.
  • Establishes strong inter-departmental relationships and is viewed as a valuable technical resource to others.
  • Direct experience with technical transfer and aseptic/parenteral pharmaceutical process validation methodologies.
  • Familiar with Code of Federal Regulations (CFR) parts 210 and 211 and supporting regulatory inspections.
  • Experience in drafting and reviewing Chemistry, Manufacturing and Controls (CMC) regulatory filing sections.
  • Ability to support travel 25%.

    Qualifications

    Must possess excellent written, verbal and presentation skills. Must be able to communicate effectively with all levels of management, both internal and external.

    Skills

    • Excellent technical problem-solving skills with root cause analysis tools.
    • Strong project management skills.
    • Effective organizational and time management skills.
    • Ability to work well independently and in a team environment.
    • Knowledge of industry regulations and guidelines (e.g., FDA, EMA).
    • Ability to support travel 25%.