Associate Process Development Engineer

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

Summary

Responsible for supporting the Production Services Operations Team with engineering programs, procedures, and systems that deliver products that consistently meet or exceed customer, regulatory, and company requirements. This position will support Technical Transfer activities, improve current manufacturing processes and supporting procedures; analyze and solve problems from basic engineering principles through advanced problems; and prepare and execute commissioning, qualification, and validations for new equipment and computerized systems/software.

Essential Duties And Responsibilities

• Participates in and supports Technical Transfer/Process Development projects including but not limited to:
  • Create and maintain product assembly instructions.
  • Assure product and process quality by designing testing methods, testing finished goods, determining product and process capabilities, establishing standards, and confirming manufacturing processes with guidance from management.
  • Validate and implement new or transferred manufacturing equipment, computer system/software validations.
  • Conduct risk assessment on process steps and their ability to meet requirements.
  • Improve manufacturing efficiency by analyzing and planning workflow, space requirements, and equipment layout.
• Participates in and supports validation projects within cGMP regulated manufacturing areas including but not limited to:
  • Prepare, review, and execute commissioning, qualification, and validation documents for equipment and computerized systems/software.
  • Support project teams in user requirement specifications, GMP impact assessments, traceability matrices, design qualifications, and risk assessments.
  • Handle multiple commissioning, qualification, and validation priorities based on needs of manufacturing areas and project teams with guidance from management.
  • Design and execute engineering (pre-validation) studies to support validation activities.
  • Assist in troubleshooting of equipment/computer system issues, process characterization, and root cause investigations.
  • Resolve deviations/non-conformances observed during execution of qualification and validation activities.
  • Prepare/issue change controls, CAPAs, and investigations.
  • Apply FMEA to evaluate failure data and implement engineering solutions.

Other Duties And Responsibilities

• Safely perform duties following NACS quality standards.
• Participate in team building, training, and department communications.
• Work as a team player with management and co‑workers to develop win‑win partnerships through positive relationships and excellent interpersonal skills.
• Maintain commitment to NACS’s vision and spirit by partnering with employees, demonstrating outstanding service and integrity.
• Communicate effectively to help all employees understand overall company objectives and their role in achieving them.
• Other duties may be assigned.

Qualifications

Minimum of Bachelors Degree in Biomedical/Mechanical Engineering or other relevant Engineering discipline. To perform this job successfully, the individual must be able to perform each essential duty satisfactorily.

• Apply sound engineering logic to solve complex problems, assess risks, and make decisions.
• Basic understanding of ISO quality system requirements and FDA regulations.
• Identify root cause of technical issues and implement effective solutions promptly.
• Creative thinker who can innovate in a fast‑paced entrepreneurial environment.
• Resourceful and adaptable to a variety of situations.
• Prioritize, initiate, and drive projects to completion.
• Solid knowledge of engineering fundamentals applicable to manufacturing and product.
• Strong attention to detail.
• Well organized.
• Proficient with MS Office (Word, Excel).
• Good written and verbal communication skills.

Education And/or Experience

Bachelors Degree in Biomedical/Mechanical Engineering or other relevant Engineering discipline with preferably 1-3 years of relevant experience, or 5-7 years of experience without a university degree.

Language Skills

Experience in equipment qualification and computer system/software validation preferred.

Read, analyze, explain complex documentation and communicate effectively with all levels within the company.

Mathematical Skills

Knowledge and application of mathematics, trigonometry, algebra, and statistics.

Reasoning Ability

Able to foresee changing project schedules and adjust assignments accordingly; adapt to rapidly changing work environment while maintaining departmental effectiveness.

Physical Demands

The employee is regularly required to stand, sit, talk, walk, use hands, see, and hear. Drive to customer sites for meetings. Infrequent lifting up to 25 pounds is required.

Work Environment

The work environment is generally clean with moderate noise. Occasional welding smoke or cleaning solvent smell. Production environment will include an ISO class 7 or 8 cleanroom.