Process Engineer III Onsite 6-Month Contract - Validation

Connexion Systems & Engineering Inc.; Sudbury (MA); On-site; USD 83,000 - 110,000; Full time

Job summary

Connexion Systems & Engineering is seeking an experienced Process Engineer III for a 6-month contract in Sudbury, MA. This onsite role focuses on technology transfer, validation, and optimization of chemical manufacturing processes within a regulated life sciences environment.

You will lead IQ/OQ/PQ validation activities, develop process diagrams and documentation, and drive continuous improvement through data-driven decisions, CAPAs, and cross-functional collaboration with manufacturing and

Qualifications

• 7+ years of process engineering in chemical manufacturing or regulated industry.
• Strong experience with technology transfer, process validation, and scale-up.
• Familiarity with FMEA, HAZOP, CAPA, and change control processes.
• Experience in cross-functional teams in regulated environments.
• Knowledge of Lean/Six Sigma/SPC is a plus.
• Life sciences or pharma exposure preferred.

Responsibilities

• Lead technology transfer for chemical processes.
• Plan and execute IQ/OQ/PQ validations.
• Develop process flow diagrams and mass/energy balances.
• Conduct risk assessments (FMEA, HAZOP) and CAPAs.
• Investigate deviations and implement corrective actions.
• Drive process optimization and scale-up.
• Prepare manufacturing docs and work instructions.
• Collaborate with manufacturing, quality, and operations teams.

Skills

Technology transfer

IQ/OQ/PQ

cGMP

FMEA

HAZOP

CAPA

Process optimization

Data-driven decision-making

Scale-up

Education

Bachelor's degree in Chemical Engineering

Tools

IQ/OQ/PQ protocols

GMP documentation

Job description

Connexion Systems & Engineering is seeking an experienced Process Engineer III for a 6-month contract in Sudbury, MA. This onsite role focuses on technology transfer, validation, and optimization of chemical manufacturing processes within a regulated life sciences environment.

You will lead IQ/OQ/PQ validation activities, develop process diagrams and documentation, and drive continuous improvement through data-driven decisions, CAPAs, and cross-functional collaboration with manufacturing and