Process Development Engineer

Job Description

Validation & Engineering Group, Inc. (V&EG) a Pinnaql company is a leading services supplier who provides solutions for the Pharmaceutical, Biotechnology, Chemical, Food, and Medical Devices industries in the following areas: Laboratory, Compliance, Computer, Engineering, Project Management, Validation, and other services.

We are seeking a talented, dedicated individual committed to work under the highest ethics standards for the following position:

Process Development Engineer

Role Summary:

The Process Development Engineer supports the development, validation, and implementation of new manufacturing processes. The role involves equipment and process validation, documentation generation, process optimization, and cross-functional technical collaboration.

Key Responsibilities:

• Support IQ/OQ/PQ and process performance qualification activities; develop validation protocols, reports, and master validation plans.

• Design and develop in-process and receiving inspection systems for new components and processes.

• Generate equipment documentation (evaluations, PM/calibration procedures) and manufacturing instructions.

• Manage process development projects from concept through implementation; collaborate with cross-functional teams.

• Apply DOE, PFMEA, and risk analysis to characterize, optimize, and improve manufacturing processes.

• Work with technologies such as laser welding, heat bonding, injection molding, vision systems, and automation (PLC/servo/pneumatics/sensors).

Experience Requirements:

• 5-7+ years in manufacturing engineering or quality engineering within a regulated environment (medical devices, pharmaceuticals, diagnostics, biotechnology).

• Strong working knowledge of pertinent regulations like 21 CFR Part 820, GMP, and ISO 13485.

• Electrical and mechanical engineering background applied to automated manufacturing systems.

• Experience with automation/controls, tooling, fixtures, test method development, and equipment qualification.

• Proficiency in DOE, FMEA, CAPA, and root cause investigation.

• Experience supporting new product introductions and process scale-up.

Quality Expectations:

Demonstrates commitment to patient safety and product quality by complying with all applicable quality procedures. Ensures proper documentation discipline and supports Quality System compliance.

Full-time