Process Engineer

Talent Groups; Marlborough (MA); On-site; USD 110,000 - 140,000; Full time

Job summary

Talent Groups is seeking an experienced Process Engineer III to support chemical manufacturing, tech transfer, equipment qualification, validation, process optimization, and scale-up in a regulated life sciences environment.

The role requires 7–10+ years of process engineering experience, strong knowledge of cGMP and ISO standards, and collaboration across functions to ensure quality and efficiency in Marlborough, MA.

Qualifications

• 7–10+ years of process engineering experience.
• Hands-on experience with process/equipment validation and IQ/OQ/PQ.
• Strong knowledge of cGMP, ISO standards, deviation investigations, CAPA, change control, and risk assessments.
• Experience with process development, technology transfer, scale-up, and optimization.
• Knowledge of SPC/statistical tools.
• Strong communication and cross-functional collaboration skills.
• Lean Manufacturing, Six Sigma, or continuous improvement experience (preferred).

Responsibilities

• Support chemical manufacturing, process tech transfer, equipment qualification, validation, process optimization, and scale-up.

Skills

Process validation

IQ/OQ/PQ

cGMP

ISO standards

Deviation investigations

CAPA

Change control

Risk assessments

Technology transfer

Scale-up

Optimization

SPC

Statistical tools

Education

Bachelor’s degree in Chemical Engineering

Tools

Job description

We are seeking an experienced Process Engineer III to support chemical manufacturing, process tech transfer, equipment qualification, validation, process optimization, and scale-up within a regulated life sciences manufacturing environment.

Required Qualifications

• Bachelor’s degree or higher in Chemical Engineering or a related engineering discipline.
• 7–10+ years of process engineering experience, preferably in chemical manufacturing.
• Hands‑on experience with process/equipment validation and IQ/OQ/PQ.
• Strong knowledge of cGMP, ISO standards, deviation investigations, CAPA, change control, and risk assessments.
• Experience with process development, technology transfer, scale‑up, and optimization.
• Knowledge of SPC/statistical tools.
• Strong communication and cross‑functional collaboration skills.

Preferred: Lean Manufacturing, Six Sigma, or continuous improvement experience.