Process Validation Engineer

Title: Process Validation Engineer Location: Framingham, MA (Hybrid) Duration: Long-term Contract Experience Required: 8+ Years Serialization Experience: Mandatory

Job Summary:

We are seeking an experienced Process Validation Engineer to join a leading pharmaceutical manufacturing team in Framingham, MA. This role requires strong hands-on expertise in tablet, ointment, and liquid dosage forms , and serialization experience is a must . The ideal candidate will be responsible for supporting process validation activities, investigations, change controls, and continuous improvement initiatives.

Key Responsibilities:

Serve as the Subject Matter Expert (SME) for process investigations, deviations, and change orders.

Provide technical assistance to manufacturing and quality operations for process troubleshooting and root cause analysis .

Lead the planning, execution, and documentation of engineering, investigational, and validation studies (including process and definition validation runs).

Develop and support critical process parameters to ensure robust and compliant processes.

Utilize engineering fundamentals and process control strategies to drive efficiency and compliance.

Document, analyze, and interpret validation and study results with actionable recommendations.

Ensure the commercialization of robust and efficient processes and test methods aligned with cGMP standards.

Collaborate with cross-functional teams to resolve issues and implement continuous process improvements.

Must-Have Qualifications:

8+ years of hands-on experience in process validation and large-scale process equipment design , scale-up , and implementation .

Strong knowledge of pharmaceutical dosage forms : tablet, ointment, and liquid.

Proven experience with serialization systems and processes (MANDATORY).

Proficiency in deviation management , change control , investigations , and root cause analysis .

Bachelor’s or Advanced Degree in Chemical or Biochemical Engineering .