Validation Engineer

Validation Engineer

Oro Valley, Arizona

Onsite

Contract

Title:

Validation Engineer

*** We are seeking a proactive Validation Engineer with 1-3 years of experience in a regulated manufacturing environment (medical devices, pharma, or biotech, preferably FDA) to ensure compliance and drive operational integrity**
* *** This is an on-site position that focuses on equipment validation. Pay range for this position is $39/hr-$42/hr, depending on experience***

•

Experience:

1-3 years of experience in a regulated manufacturing environment (medical devices, pharma, or biotech, preferably FDA)

• Focus:
Equipment Qualification

•

Employment Type:

On-site position

Responsibilities

• Develops, prepares, and executes IQ, OQ, and PQ protocols and reports for equipment/systems.
• Conducts risk assessments and develops qualification strategies for new and existing equipment/systems.
• Analyzes and interprets qualification data, ensuring accuracy, completeness, and adherence to regulatory and internal requirements.
• Collaborates with cross-functional teams, including Process Engineering, Automation Maintenance Support, Design Transfer Operations, Manufacturing, Quality, Facilities, and Safety Health and Environment (SHE), to ensure seamless execution of qualification activities and successful achievement of qualification-related project milestones.
• Participates in process optimization and continuous improvement initiatives to enhance quality and efficiency.
• Ensures compliance with FDA, ISO, and other relevant regulatory guidelines, as well as adherence to internal requirements.
• Provides training and guidance to manufacturing and quality personnel on qualification processes and procedures.
• Maintains equipment/systems qualification documentation and ensures traceability and accessibility for audits and inspections.
• Other duties as assigned by management.

Qualifications

• Bachelor's Degree in Engineering or Life Science.
• Strong technical writing, analytical, and problem-solving skills.
• Knowledge of cGMP and regulatory standards.
• Demonstrated experience assisting with or supporting qualification activities within the medical device, pharmaceutical, or biotechnology industry is required.

Skills:

You will receive the following benefits:

• Medical Insurance - Four medical plans to choose from for you and your family
• Dental & Orthodontia Benefits
• Vision Benefits
• Health Savings Account (HSA)
• Health and Dependent Care Flexible Spending Accounts
• Voluntary Life Insurance, Long-Term & Short-Term Disability Insurance
• Hospital Indemnity Insurance
• 401(k) including match with pre and post-tax options
• Paid Sick Time Leave
• Legal and Identity Protection Plans
• Pre-tax Commuter Benefit
• 529 College Saver Plan

Motion Recruitment Partners (MRP) is an Equal Opportunity Employer. All applicants must be currently authorized to work on a full-time basis in the country for which they are applying, and no sponsorship is currently available. Employment is subject to the successful completion of a pre-employment screening. Accommodation will be provided in all parts of the hiring process as required under MRP's Employment Accommodation policy.

Applicants need to make their needs known in advance.

Specialization:
Mechanical Engineering