Sr. Validation Engineer

BW Design Group; Indianapolis (IN); On-site; USD 75,000 - 115,000; Full time

Job summary

An established industry player seeks a dedicated Sr. Validation Engineer to join their dynamic team. In this role, you will prepare and execute critical validation documents for pharmaceutical equipment, ensuring compliance with FDA standards. You will collaborate with industry experts, contributing to impactful projects while enhancing your professional growth. This opportunity offers a supportive culture that promotes mutual respect and integrity, empowering you to make a significant impact in the field. If you have a passion for validation and a desire to grow in your career, this role is perfect for you.

Qualifications

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

Responsibilities

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

Skills

Validation of pharmaceutical processes

FAT, SAT, IQ, OQ documentation

Leadership skills

Communication skills

Interpersonal skills

Computer skills

Willingness to travel

Education

Bachelor’s degree in Engineering

Job description

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Must be legally authorized to work in the United States without sponsorship.

Who You’ll Work With

You will join one of our 45 offices in the US, be part of a committed team of over 1500 professionals, and work directly with our clients on impactful projects. You will be welcomed into a growing business and team, empowered to make an impact, and supported in your professional growth. You will work with industry experts in our Regulatory Compliance Practice, delivering high-quality solutions to our clients.

What You’ll Do

• Prepare, execute commissioning and qualification documents for utility, facility, and process equipment.
• Develop and execute validation and FDA compliance documents/protocols for pharmaceutical equipment.
• Contribute your skills daily to strengthen client and team relationships.

What You’ll Bring

• Minimum 5 years of experience in validation of pharmaceutical or medical device processes and equipment.
• Experience with FAT, SAT, IQ, and OQ documentation on Automated Systems in the Pharmaceutical Industry.
• Validation experience in automation, packaging, cleaning, computer systems, utilities, or facilities is preferred.
• Strong leadership, communication, interpersonal, and computer skills.
• Willingness to travel for project needs.
• Bachelor’s degree in Electrical, Mechanical, Chemical Engineering, or related field.

Our culture promotes mutual respect, integrity, and professional development. We support your growth through mentorship, development plans, and a rewarding career path. If you're on the path to becoming a Sr. Validation Engineer, we'd love to connect and help you grow into a Design Group Engineering Consultant.