Process Engineer l - NJ

Perspective Therapeutics-posted 2 months ago
Entry Level
Hybrid • Somerset, NJ
101-250 employees
Miscellaneous Manufacturing
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Join a great team that is working to target cancer from the inside out! 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. This is a hybrid role, based part-time in the office and part-time remote, with the office located in Somerset, NJ.

  • Identify opportunities to improve quality, efficiency, and customer service through changes to product components, component processing, and component inspection.
  • Work with multi-functional teams to execute product and packaging projects to improve and optimize manufacturing and packaging processes.
  • Provide technical support for the transfer of new or improved manufacturing processes between functional groups or sites.
  • 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.
  • Provide support in the development, review, and maintenance of various radiopharmaceutical and cGMP documents.
  • Assist in the development of training materials and conduct training sessions for target audience on document updates.
  • Present data and information as a technical subject matter expert to regulatory agencies.
  • Actively promote safety and demonstrate good safety practices.
  • Write and manage actions for change controls in Quality Management System (QMS) as applicable for tech transfers.
  • Stay up to date with industry regulations and guidelines to ensure compliance.
  • 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.
  • Excellent written, verbal and presentation skills.
  • Self-starter with the ability to work well both independently and in a team environment.
  • Demonstrated technical problem-solving skills with root cause analysis tools.
  • Direct experience with project management skills.
  • Excellent organizational and time management skills.
  • Direct experience with technical transfer and aseptic/parenteral pharmaceutical process validation methodologies.
  • Familiar with Code of Federal Regulations (CFR) parts 210 and 211.
  • Experience in drafting and reviewing Chemistry, Manufacturing and Controls (CMC) regulatory filing sections.
  • Previous experience working with radiopharmaceuticals and CMOs strongly preferred.
  • Establishes strong inter-departmental relationships and is viewed as a valuable technical resource to others.
  • Medical insurance
  • Dental insurance
  • Vision insurance
  • Flexible Spending Account (FSA)
  • Life insurance
  • Short & long-term disability insurance
  • 401k with a company match
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