Validation Engineer Jobs

About The Position

Requirements

• Typically requires a bachelor's degree in engineering or a related field, or equivalent experience and training.
• Six years of quality or validation experience.
• Prior process and/or facilities validation experience in the medical device, pharmaceutical, or biotechnology industry.
• Understanding of CFR Part 820, Part 11, ISO 13485, Annex 11, and ISO 9001.
• Working knowledge of process and facilities validation and GAMP standards.
• Experience generating, reviewing, and approving validation deliverables, and with statistical analysis, risk management, incident management, and change management.
• Experience in a prior quality assurance role.
• Ability to work independently with minimal supervision.
• Excellent communication, organizational, project management, and decision-making skills.

Nice To Haves

• Experience working in a 24/7 operations environment.

Responsibilities

• Guide and support the validation team, providing validation and quality assurance oversight for process and facilities validation and qualification activities, and recommend corrective actions as needed.
• Ensure validation policies and procedures are implemented and followed for medical device manufacturing.
• Implement and coordinate product assurance programs to prevent or eliminate defects in new or existing products.
• Research and present information on business situations, production capabilities, manufacturing problems, economic trends, and product design and development for management consideration.
• Evaluate alternative methods and procedures to solve problems and address business needs and changing market opportunities.
• Collaborate with management personnel to formulate and establish company policies, operating procedures, and goals.
• Develop and modify product assurance programs, defining areas of control, personnel requirements, and operational procedures.
• Interface with customers on technical and quality issues and improvement initiatives.
• Manage regulatory, compliance agency, and customer audits, serving as a subject matter expert for the relevant area or business process.
• Review technical problems and procedures and recommend solutions to improve and streamline quality system processes.
• Implement validation controls across manufacturing areas in line with applicable policies and procedures.
• Execute and manage validation and control activities by authoring, reviewing, and approving validation deliverables, including plans, requirement test plans, protocols, results, risk assessments, traceability matrices, and summary reports.
• Monitor validation deliverables and activities in assigned areas to ensure applicable regulations, protocols, procedures, and methodologies are followed and complete documentation is captured and reported.
• Support other validation areas as required by the business.

Benefits

• Medical, dental, and vision plans
• Life insurance
• Short-term and long-term disability
• Matching 401(k) contributions
• Vacation and paid sick time
• Tuition reimbursement