Process Development Engineer: Tech Transfer & Validation

Burke Porter, an Ascential Technologies Brand; Ham Lake (MN); On-site; USD 65,000 - 85,000; Full time

Job summary

Burke Porter, an Ascential Technologies Brand, is looking for an engineering professional in Ham Lake, Minnesota. The role involves supporting the Production Services Operations Team with engineering programs that ensure product quality and compliance with regulations. You will participate in Technical Transfer and Process Development projects, focusing on validating manufacturing equipment and improving processes.

The ideal candidate will have a Bachelor’s Degree in Biomedical or Mechanical Engineering and preferably 1-3 years of experience. A strong background in problem-solving and ISO quality systems is essential.

Qualifications

• Minimum of Bachelors Degree in Biomedical/Mechanical Engineering or relevant discipline.
• 1-3 years of relevant experience preferred; 5-7 years without a degree considered.
• Experience in equipment qualification and computer system validation preferred.

Responsibilities

• Support Technical Transfer/Process Development projects.
• Assure product quality by designing testing methods.
• Conduct risk assessments and improve manufacturing efficiency.
• Prepare and execute validation documents for equipment.

Skills

Sound engineering logic

ISO quality system knowledge

Problem-solving

Creativity

Adaptability

Project management

Attention to detail

MS Office proficiency

Communication skills

Education

Bachelors Degree in Biomedical/Mechanical Engineering

Job description

Burke Porter, an Ascential Technologies Brand, is looking for an engineering professional in Ham Lake, Minnesota. The role involves supporting the Production Services Operations Team with engineering programs that ensure product quality and compliance with regulations. You will participate in Technical Transfer and Process Development projects, focusing on validating manufacturing equipment and improving processes.

The ideal candidate will have a Bachelor’s Degree in Biomedical or Mechanical Engineering and preferably 1-3 years of experience. A strong background in problem-solving and ISO quality systems is essential.