Validation Engineer Lead at Validation & Engineering Group

Juncos, , Puerto Rico -

Full Time

Start Date

Immediate

Expiry Date

08 Feb, 26

Salary

0.0

Posted On

10 Nov, 25

Experience

5 year(s) or above

Remote Job

Yes

Telecommute

Yes

Sponsor Visa

Skills

Commissioning, Qualification, Downstream Processing, GMP Regulations, Validation Protocols, Automation Systems, FDA Guidelines, EMA Guidelines, ICH Guidelines, Communication Skills, Documentation Skills, Risk Assessments, Change Control, Field Inspections, Functional Verifications, Single-Use Technologies, Greenfield Projects

Industry

Engineering Services

Description

Company Description Validation & Engineering Group, Inc. (V&EG) 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. Job Description Key Responsibilities: Develop, review, and execute commissioning and qualification protocols (IQ/OQ/PQ) for downstream processing equipment. Coordinate FAT/SAT execution and documentation with vendors and engineering teams. Perform field inspections, loop checks, and functional verifications during commissioning. Ensure equipment is installed and operates per design specifications, user requirements, and cGMP standards. Support resolution of deviations and discrepancies identified during commissioning and qualification. Author and/or review commissioning plans, traceability matrices, risk assessments, and validation summary reports. Interface with validation, manufacturing, automation, and QA to ensure alignment and timely execution of CQV activities. Participate in change control evaluations and equipment impact assessments. Downstream Equipment in Scope: Chromatography Skids. Tangential Flow Filtration (TFF) systems. Depth filtration units. Centrifuges and continuous flow centrifuges. Virus filtration and inactivation systems. Bulk product hold tanks and transfer skids. Clean-in-place (CIP) and Steam-in-place (SIP) systems. Qualifications Qualifications: Bachelor’s degree in engineering, biotechnology, or related life sciences discipline. 3–7 years of CQV experience in a GMP-regulated biotech or pharmaceutical environment. Strong understanding of downstream unit operations and associated automation. Proficient in writing and executing validation protocols and working within electronic validation systems (e.g., Valgenesis, Kneat). Familiarity with FDA, EMA, and ICH guidelines. Excellent communication and documentation skills. Preferred Skills: Experience with single-use technologies (SUT) in downstream processing. Knowledge of DeltaV, Rockwell, or Siemens PLC-based automation systems. Experience working on greenfield or facility expansion projects.

Responsibilities

The Validation Engineer Lead will develop, review, and execute commissioning and qualification protocols for downstream processing equipment. They will also coordinate with vendors and engineering teams to ensure compliance with design specifications and cGMP standards.