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:
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.
Validation & Engineering Group, Proudly serving our clients since 1997.
Our Mission states in part: "provide our clients with the best resources to meet their needs". In our search for the best talent, we are inclusive and do not discriminate. V&EG is proud to be an equal opportunity workplace and is an affirmative action employer.
Validation & Engineering Group provides world-class service and expertise to the pharmaceutical, medical device and biotechnology industries. We offer our clients: Validation, Control System Solutions, Instrumentation, Training, Equipment Rentals, and Regulatory Compliance Services to ensure adherence to Federal and European regulatory agencies. Our group had serve in solid dosages, liquids, creams, lyophilizers, and parenteral dosage.
Our agility in responding to our clients’ needs, access to the best pool of talent, and the combined experience and technical expertise of our resources make Validation & Engineering Group a leader in the pharmaceutical, medical devices, and biotechnology industries.
At Validation & Engineering Group we provide professional expertise in the areas of:
•Audit and Assessment
•Automated Process Control System Qualification
•Equipment and Facilities Qualification
•Facilities Start-Up and Commissioning
•GAP Analysis
•Information Systems Computer Validation
•Packaging and Process Analysis
•Process & Cleaning Validation
•Project Management
•Quality Systems
•Risk Based Approach
•Regulatory Compliance
•Standard Operating and Maintenance Procedures
•Training
•Utilities Support and Qualification
In addition we offer Equipment Rentals and training to your workforce such as: Temperature & Relative Humidity, Electrical, Process, Environmental, and. Analytical.
Our Offices:
Puerto Rico:
Centro Internacional de Mercadeo I 100 Carr. 165 Ste 703, Guaynabo, 00968 Puerto Rico
Phone: (787) 622-0996
United States:
2180 Satellite Blvd, Suite 400Duluth, Georgia 30097 United States
Phone: (770) 403-5802
