Process Development Engineer in 00646

Job DescriptionJob 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

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

Requirements:

• 5–7+ years in manufacturing engineering or quality engineering within an FDA-regulated environment (medical devices, pharma, diagnostics, biotech).
• Strong working knowledge of 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.

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).

At Validation & Engineering Group, people always come first. We believe that when you're empowered to do your best work, bold ideas thrive and real progress happens. This isn't just a job - it's an opportunity to make a meaningful difference by shaping the future of healthcare and technology alongside a purpose-driven, supportive team.

Excited to build something meaningful together? We look forward to hearing from you.

Validation & Engineering Group is an equal opportunity employer. All applicants will be considered for employment without regard to , , , , , , , veteran status, or status.