Process Validation Engineer

Job Title : Process Engineer (Validation)

Location : Greater Boston, MA Area (100% Onsite)

Employment Type : Contract (W2)

Duration : 12+ months

About the Role

This role focuses on process validation and technology transfer for chemical manufacturing processes within a life sciences environment. The Process Engineer will lead validation activities, support scale-up, and drive process improvements while ensuring compliance with cGMP and quality standards.

Responsibilities

• Lead equipment and process validation activities including IQ/OQ/PQ

• Support tech transfer of chemical manufacturing processes

• Develop process flow diagrams, mass & energy balances

• Conduct risk assessments including HAZOP and FMEA

• Lead development and execution of work instructions

• Support deviation investigations and implement corrective actions

• Drive process improvements using data-driven approaches

• Promote safety and quality culture across teams

Required Qualifications

• Bachelor’s degree or higher in Chemical Engineering or related field

• 7–10 years of experience in chemical manufacturing or related field

• Strong experience with process and equipment validation (IQ/OQ/PQ)

• Knowledge of cGMP, ISO standards, and quality systems

• Experience with risk assessments, deviation investigations, and change control

• Strong communication and cross-functional collaboration skills

Preferred Qualifications

• Experience with tech transfer and process scale-up

• Background in polymer chemistry, proteins, or chromatography

• Knowledge of Lean Manufacturing or Six Sigma methodologies

• Experience with statistical tools and process control

Salary

The hourly rate for this position is $50-56/hr ( DOE ).

Benefits

This is a contract position and does not include employer-provided benefits.

Equal Opportunity Employer

We are an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or veteran status.

Background Check

Background checks may be conducted in accordance with applicable laws

Work Authorization

Applicants must be authorized to work in the United States