Validation Engineer

MilliporeSigma; Missouri; On-site; USD 60,000 - 90,000; Full time

Job summary

An established industry player is seeking a Validation Engineer to support pharmaceutical manufacturing in a cGMP facility. In this role, you will develop validation protocols and ensure compliance with pharmaceutical standards while collaborating with various departments. Your expertise in cleanroom operations and quality assurance will be crucial in maintaining the integrity of the manufacturing process. This position offers a unique opportunity to contribute to a diverse and inclusive environment while advancing your career in the pharmaceutical sector.

Qualifications

• 3+ years of experience in a cGMP environment.
• Knowledge of FDA, EU, ISO, ISPE standards.

Responsibilities

• Develop and approve validation testing for cleanrooms.
• Support cross-functional teams during protocol execution.
• Create validation schedules and coordinate efforts.

Skills

Validation Protocol Development

cGMP Compliance

Cross-Functional Collaboration

Quality Assurance

Cleanroom Operations

Education

Associate’s Degree

Bachelor’s Degree in Biomedical Engineering

Bachelor’s Degree in Chemical Engineering

Bachelor’s Degree in Biology

Job description

Job Title: Validation Engineer - Cleanroom & Environment Qualifications

Join MilliporeSigma as a Validation Engineer, supporting the manufacturing of pharmaceuticals in a cGMP facility. Your role will involve developing validation protocols, supporting cross-functional teams, and ensuring compliance with pharmaceutical standards.

Responsibilities

• Develop, review, and approve validation testing and protocols for cleanrooms and environments.
• Support Engineering, Maintenance, Manufacturing, and QA during protocol execution.
• Collaborate with various departments including Manufacturing, Project Management, Quality Control, and more.
• Review design documents for facilities, equipment, and analytical instruments.
• Assess the impact of changes on validated states of facilities and equipment.
• Create validation schedules and coordinate efforts with contractors and internal teams.

Qualifications

Minimum Qualifications:

• Associate’s Degree in any discipline with 3+ years of experience in a cGMP environment.

OR

• Bachelor’s Degree in Biomedical Engineering, Chemical Engineering, Biology, or related Life Science field.

Preferred Qualifications:

• 1+ years of quality support experience in a cGMP pharmaceutical setting.
• 1+ years of cleanroom operation experience.
• 1+ years of validation engineering experience.
• Knowledge of pharmaceutical standards (FDA, EU, ISO, ISPE, etc.).

Additional Information

This role does not offer sponsorship; candidates must be eligible to work in the US.

We value diversity and inclusion, and we encourage candidates from all backgrounds to apply.