Validation Engineer

Lincoln Group Industrial Services has partnered with an exceptional client in the Biopharma industry that is looking for a Validation Engineer to join their team on a direct-hire basis! The Validation Engineer will collaborate with stakeholders at all the company’s locations to conduct product, process, and equipment validations, and risk assessments, develop testing methods and various test and process validation requirements.

Type of Hire:  Direct Hire
Software: Microsoft Office Suite

Reports to: Director of Product Design & R&D
Location:  On-site in Camarillo, CA
Compensation: Up to $90K, plus benefits, 401K, and PTO.

PRINCIPAL DUTIES:

·Prepare protocols for validation or performance testing of new or modified manufacturing equipment, process, or systems.

·Maintain technical records within design history files associated with assigned products.

·Identify root causes of production problems.

·Develop and maintain databases for tracking test results, validation activities, or validated systems.

·Modify testing methods, and revisit test objectives and standards to resolve testing problems.

·Develop test methods, generate, and maintain design specifications, protocol & report writing, prototyping, DOE/SPC product optimization, design verification & validation, FMEA, etc.

·Support Product Delivery Teams (PDT), including creating and or reviewing quality documents, participating in Corrective And Preventive Action (CAPA) implementation, and generating or supporting ECR & ECO activities.

·Consult with management, evaluate customer requirements, and study product characteristics to select validation objectives and standards.

·Analyze data from validation tests to determine whether systems and processes meet the required criteria and specifications.

·Collaborate and coordinate with appropriate departments and staff regarding the scheduling or implementation of validation testing.

·Identify nonconformities of product or process standards and offer recommendations for resolving deviations.

·Develop, maintain, or review validation and compliance documentation including schematics, protocols, and engineering change notices.

·Calibrate equipment to ensure accurate measurements.

·Participate in system-level and subsystem-level root cause investigation from firmware and electrical perspectives, coordinate design improvements with development partners, tactical planning, and execution of design changes and improvements.

·Work with Scientists and Engineers internally and externally to assess and develop appropriate design and manufacturing specifications.

BASIC QUALIFICATIONS:

·Bachelor’s degree in biology, business, engineering, or a closely related field

·3+ years of validation engineering experience

·8+ years of experience in quality operations within a biotechnology or pharmaceutical manufacturing facility OR Master’s degree in science or engineering

·Excellent interpersonal skills

·Thorough understanding of applicable mathematics and scientific practices

·Proficient with Microsoft Office Suite or related software

·Excellent verbal and written communication skills

·Thorough understanding of industry standards and regulatory guidelines

·Thorough understanding of related equipment and the ability to perform equipment modifications.

About Lincoln Group Industrial Services:

We are a woman-owned staffing firm specializing in Engineering and Light Industrial. We provide you with resources directly to achieve confidence in your workplace. We serve companies looking for a holistic talent solution. First our website at www.lincolngrp.com