Pharma Process Validation Engineer – Aseptic GMP Expert

Socket.dev; Grand Rapids (MI); On-site; USD 85,000 - 120,000; Full time

Benefits offered by this job

Medical benefits

Dental benefits

Vision benefits

Life insurance

Disability insurance

401(k) with immediate vesting

Volunteer time off

PTO and Wellness time off

Job summary

Grand River Aseptic Manufacturing (GRAM) seeks a Process Validation Engineer/Specialist to support validation of cGMP equipment, facilities, and processes. Responsibilities include validating manufacturing processes and production equipment, maintaining validation procedures, and supporting internal and external customers through validation activities.

The role requires experience in pharma/biotech environments, strong project management, and readiness to work in a 24/7 manufacturing setting.

Qualifications

• 1–4 years’ related work experience in pharma/biopharma/biotech manufacturing for level I.
• 3–5 years’ related work experience for level II.
• 4–6 years’ related work experience for level III.
• Senior level: 6+ years pharma experience or equivalent with advanced degree.
• Proficient in Word, Excel, and Outlook; demonstrated project management and leadership.

Responsibilities

• Assist with maintaining and revising validation procedures.
• Establish and maintain good practices for aseptic environments.
• Develop programs covering manufacturing processes, equipment, and cleaning.
• Ensure all validation complies with GRAM and cGMP requirements.
• Provide validation support to internal customers (Technical Services, QC, Manufacturing).
• Attend client meetings and provide validation support to external customers.
• Write, review, and execute validation protocols and studies for process improvement.
• Troubleshoot and resolve process-related issues in Manufacturing.

Skills

Project management

Leadership

Microsoft Word

Excel

Outlook

Cleanroom operations

Education

Bachelor’s degree in engineering or life sciences

Tools

Microsoft Word

Excel

Outlook

Job description

Grand River Aseptic Manufacturing (GRAM) seeks a Process Validation Engineer/Specialist to support validation of cGMP equipment, facilities, and processes. Responsibilities include validating manufacturing processes and production equipment, maintaining validation procedures, and supporting internal and external customers through validation activities.

The role requires experience in pharma/biotech environments, strong project management, and readiness to work in a 24/7 manufacturing setting.