Process Validation Engineer — Impactful GMP Manufacturing

Grand River Aseptic Manufacturing Inc.; Grand Rapids, Northern (MI, KY); Hybrid; USD 90,000 - 130,000; Full time

Benefits offered by this job

Benefits starting day 1

Paid volunteer time

Paid time off (PTO)

Wellness time off (WTO)

Paid holidays

Job summary

Grand River Aseptic Manufacturing (GRAM) in Grand Rapids, MI, seeks a Process Validation Engineer/Specialist to validate cGMP manufacturing processes, equipment, and facilities. The role requires 1–6 years in pharma/biotech environments with demonstrated project management, leadership, and willingness to work a 24/7 operation.

Knowledge of GMP, cleanrooms, and tech transfer is preferred. Full description available during the interview process.

Qualifications

• Minimum 1–4 years in pharma/biotech manufacturing for Level I.
• Minimum 3–5 years in pharma/biotech manufacturing for Level II.
• Minimum 4–6 years in pharma/biotech manufacturing for Level III.
• Senior level: 6+ years in pharma with related advanced degree or PhD.
• Proficient MS Word, Excel, Outlook; strong PM and leadership skills.
• Willingness to work in a 24/7 manufacturing environment.

Responsibilities

• Assist with maintaining and revising validation procedures.
• Establish and maintain aseptic practices in processes.
• Execute validation programs covering manufacturing processes, equipment, and cleaning.
• Ensure all validation activities conform to GRAM and cGMP requirements.
• Provide validation support to internal customers (Technical Services, Quality Control, Manufacturing).
• Attend client meetings and support external customers during tech transfer activities.
• Write, review, and execute protocols and studies for process improvement and scale-up.
• Troubleshoot manufacturing/process issues and communicate progress regularly.
• Identify opportunities for process improvements and equipment needs.

Skills

MS Word/Excel/Outlook

Project management

Leadership

Cleanroom work

24/7 operations

Education

Bachelor’s degree in engineering or life sciences

Job description

Grand River Aseptic Manufacturing (GRAM) in Grand Rapids, MI, seeks a Process Validation Engineer/Specialist to validate cGMP manufacturing processes, equipment, and facilities. The role requires 1–6 years in pharma/biotech environments with demonstrated project management, leadership, and willingness to work a 24/7 operation.

Knowledge of GMP, cleanrooms, and tech transfer is preferred. Full description available during the interview process.