Validation Engineer

Barry-Wehmiller Companies Inc.; Boston (MA); On-site; USD 70,000 - 95,000; Full time

Job summary

A leading engineering consulting firm seeks a Validation Engineer II in Boston. This role involves ensuring compliance and developing critical validation documentation for pharmaceutical equipment. The ideal candidate will have 3 years of industry experience and a relevant degree, alongside strong communication skills. Join a dedicated team of professionals focused on solving complex challenges in a growing business environment.

Qualifications

• Minimum of 3 years project experience in validation.
• Experience in pharmaceutical or biotechnology is a plus.
• Proficiency with Microsoft Office and technical writing required.

Responsibilities

• Develop and execute validation and FDA compliance-related documents.
• Perform investigations and troubleshoot validation issues.
• Prepare validation reports and maintain documentation.

Skills

Communication

Interpersonal skills

Technical writing

Education

B.S. in Bioengineering

B.S. in Biomedical Engineering

B.S. in Chemical Engineering

Tools

Microsoft Office

Microsoft Project

AutoCAD

Job description

About Us:

BW Design Group is a fully integrated architecture, engineering, construction, system integration, and consulting firm committed to helping our clients realize their most critical goals from Strategy to Commercialization. As the only firm born from a manufacturing technology company to become an independent and fully integrated firm, we combine deep domain expertise in the manufacturing environment with an approach that is built to serve the dynamic needs of our clients. Rooted in our distinct culture of Truly Human Leadership, we cultivate the leaders who will define tomorrow and partner with our clients in the food & beverage, life sciences, industrial, and advanced technology industries to build the future of manufacturing and technology.

Barry-Wehmiller is a diversified global supplier of engineering consulting and manufacturing technology for the packaging, corrugating, sheeting and paper-converting industries. By blending people-centric leadership with disciplined operational strategies and purpose-driven growth, Barry-Wehmiller has become a $3 billion organization with nearly 12,000 team members united by a common belief: to use the power of business to build a better world.

Job Description:

Validation Engineer

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 in teams and directly with our clients doing work that is shaping the world around us. You will be welcomed into a rapidly growing business and team and empowered to make an impact. You will be valued, cared for, and challenged on your path to becoming a world-class professional consultant and surrounded by leaders who are committed to creating an environment that enables you to realize your own success and fulfillment.

When you join Design Group as a Validation Engineer II, you are joining a team that will challenge you and position you for growth. In this role, you will work with a team of industry experts to help the world’s leading companies solve their most difficult problems. You will join our Regulatory Compliance Practice and partner with seasoned leaders, technical specialists, and subject matter experts to deliver the highest quality solutions to our clients with consistency and accuracy.

What You’ll Do

• Develop and execute validation and FDA compliance-related documents/protocols for pharmaceutical equipment, including FAT, SAT, IQ, and OQ documentation on automated systems.
• Assist in developing and executing QMS procedures, ICH Q1 (Stability Protocols/Reports), CFR 21 Part 211, CFR 21 Part 820, ICH Q8, Q9, and Q10.
• Perform investigations and troubleshoot validation issues.
• Prepare validation reports.
• Support capital projects, design manufacturing processes, manage projects, and develop facilities.
• Travel to client sites for project installation, start-up activities, and meetings.
• Establish validation standards, develop validation protocols, and oversee compliance resolution.
• Maintain validation documentation such as specifications, SOPs, work instructions, and testing records.
• Ensure processes, products, equipment, and systems comply with external regulations and standards.
• Assist with new equipment purchases or upgrades.
• Other duties as assigned.

What You’ll Bring

• Good communication and interpersonal skills, with flexibility and ability to interact with all management levels, clients, and vendors.
• Minimum of 3 years project experience in validation of automation, packaging, utilities, or facilities.
• Experience in pharmaceutical, biotechnology, or medical device environments is a plus.
• Experience in gown-room environments is a plus.
• Strong technical writing and oral communication skills.
• Proficiency with Microsoft Office, Microsoft Project, and AutoCAD.
• Willingness to travel as necessary.
• B.S. in Bioengineering, Biomedical Engineering, Chemical Engineering, or related field.

Barry-Wehmiller values diversity and encourages candidates from all backgrounds to apply. We are an equal opportunity employer and use E-Verify. Pre-employment screening may include drug testing, background checks, and skills assessments.