Sr Validation Engineer

Katalyst CRO; Columbia (MD); On-site; USD 70,000 - 110,000; Full time

Job summary

An established industry player is seeking a skilled validation engineer to ensure compliance with FDA regulations and validation of pharmaceutical processes. This role involves preparing and executing critical documentation for various utilities and equipment, while also engaging with clients and team members to foster strong relationships. The ideal candidate will have a strong background in engineering, excellent leadership capabilities, and the ability to manage multiple projects simultaneously. If you're passionate about making a significant impact in the pharmaceutical industry, this opportunity is perfect for you.

Qualifications

• 5+ years of experience in validation of pharmaceutical or medical device processes.
• Experience with FAT, SAT, IQ, and OQ documentation development.

Responsibilities

• Prepare and execute commissioning and qualification documents.
• Develop validation and FDA compliance documents for pharmaceutical equipment.

Skills

FDA Compliance

Validation of Pharmaceutical Processes

Leadership Skills

Communication Skills

Interpersonal Skills

Computer Skills

Education

Bachelor's Degree in Electrical Engineering

Bachelor's Degree in Mechanical Engineering

Bachelor's Degree in Chemical Engineering

Tools

Automated Systems

Job description

Responsibilities:

• Responsible for preparing, executing commissioning and qualification documents for a variety of utilities, facility, and process equipment.
• Develop and execute a variety of validation and FDA compliance related documents/protocols for pharmaceutical equipment.
• Make an impact day-to-day with your skills and expertise, strengthening that relationship with our clients and team.
• Excellent leadership skills include the ability to simultaneously organize, and successfully execute multiple project responsibilities.
• Candidates need to possess good communication and interpersonal skills and the ability to interact with all levels of management, clients, and vendors.
• Strong computer skills are also required.

Requirements:

• Minimum 5 years of demonstrated experience with validation of pharmaceutical or medical device processes and equipment.
• FAT, SAT, IQ and OQ documentation development and execution on Automated Systems in the Pharmaceutical Industry.
• Validation experience in the areas of automation, packaging, cleaning, Computer systems, utilities and/or facilities is desired.
• Willing and able to travel as necessary for project requirements to include but not limited to project installation and start-up activities, client meetings, company sponsored meetings, trainings, industry related seminars, forums, or conventions, etc.
• Bachelor's degree in electrical engineering, Mechanical Engineering, Chemical Engineering, or equivalent technical degree.