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Pinnaql · 2 weeks ago

Process Development Engineer

Dorado, PR

Full-time

Onsite

Senior Level

5+ years exp

Validation & Engineering Group, Inc. (V&EG), a Pinnaql company, provides engineering, validation, and related services to regulated industries. The Process Development Engineer supports the development, validation, implementation, optimization, and scale-up of manufacturing processes, while collaborating with cross-functional teams and preparing technical documentation.

Biotechnology

H1B Sponsor Likely

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)

Qualification

Manufacturing EngineeringFDA-Regulated Manufacturing21 CFR Part 820Manufacturing Practice (GMP)ISO 13485Electrical EngineeringMechanical EngineeringAutomated Manufacturing SystemsAutomation and ControlsEquipment QualificationDesign of Experiments (DOE)Failure Mode and Effects Analysis (FMEA)Corrective and Preventive Action (CAPA)Root-Cause InvestigationProcess Scale-Up

Required

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

Company

Pinnaql

Life sciences consulting for engineering, quality, and compliance.

Founded in 2019

King Of Prussia, Pennsylvania, USA

201-500 employees

https://www.pinnaql.co

H1B Sponsorship

Pinnaql has a track record of offering H1B sponsorships. Please note that this does not guarantee sponsorship for this specific role. Below presents additional info for your reference. (Data Powered by US Department of Labor)

Distribution of Different Job Fields Receiving Sponsorship

100%

Represents job field similar to this job

Engineering and Development

Trends of Total Sponsorships

*2024 (1)

Funding

Current Stage

Growth Stage

Recent News

PR Newswire

Pinnaql Acquires Pharma Resource Group, Expanding Engineering, Validation, Tech Transfer, and Manufacturing Support for Life Sciences Clients

2026-05-20

Pharma Letter

Pinnaql enters M&A market again

2026-05-02

PR Newswire

Pinnaql Acquires Pharma Resource Group, Further Expanding Scientific and Manufacturing Advisory Capabilities

2026-04-30

Company data provided by crunchbase