Associate Process Development Engineer: Validation

Ascential Technologies; Andover (MN); On-site; USD 85,000 - 110,000; Full time

Job summary

Ascential Technologies is seeking an engineer to support Production Services Operations with engineering programs, procedures, and systems to meet customer, regulatory, and company requirements. The role includes technical transfer activities, process improvement, and commissioning/qualification for new equipment and computerized systems.

Ideal candidates hold a biomedical or mechanical engineering degree with 1–3 years of experience or 5–7 years without a degree.

Qualifications

• Bachelor's degree in Biomedical/Mechanical Engineering or related field.
• 1–3 years of relevant experience or 5–7 years without a degree.
• Experience with equipment qualification and computer system/software validation preferred.

Responsibilities

• Supports Technical Transfer/Process Development projects and creates assembly instructions.
• Validates and implements manufacturing equipment and computer systems; writes validation documents.
• Performs risk assessments, improves workflow, and plans layouts for efficiency.
• Supports cGMP manufacturing validation activities and develops CQV deliverables.
• Assists in deviations investigations and change controls.

Skills

Engineering fundamentals

Problem solving

Written and verbal communication

MS Office proficiency

Attention to detail

Education

Bachelor's degree in Biomedical/Mechanical Engineering

Tools

MS Office

Computer System Validation

Job description

Ascential Technologies is seeking an engineer to support Production Services Operations with engineering programs, procedures, and systems to meet customer, regulatory, and company requirements. The role includes technical transfer activities, process improvement, and commissioning/qualification for new equipment and computerized systems.

Ideal candidates hold a biomedical or mechanical engineering degree with 1–3 years of experience or 5–7 years without a degree.