Validation Engineer

Caelum Research Corporation; Carmel (IN); On-site; USD 95,000 - 130,000; Full time

Job summary

BW Design Group in the United States is seeking a Validation Engineer to support capital projects and implement solutions for our pharma clients. You will develop and execute validation and FDA compliance documents for pharmaceutical equipment, with travel to top clients across the country to assist in design, qualification, and start-up activities.

The role requires 7+ years of experience in pharma or medical devices, strong technical writing, and the ability to interact with all management

Qualifications

• 7+ years of project experience in pharmaceutical or medical device environments.
• Strong technical writing and oral communication skills.
• Willingness to travel to client sites.
• Understanding of ICH Q7–11, 21 CFR Parts 210, 211, ISPE Baseline Guides, GAMP5, and ASTM E2500.

Responsibilities

• Develop and execute validation and FDA compliance documents/protocols for pharmaceutical equipment.
• Travel to top clients across the country to assist in design of manufacturing processes and facility/start-up activities.
• Perform risk assessments, trace matrices, and validation deliverables; prepare validation reports.

Skills

Communication skills

Interpersonal skills

Travel willingness

Project coordination

Technical writing

Education

B.S. in Bioengineering / Biomedical Engineering / 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

What You'll Do

You will work individually and in teams to support capital projects and implement solutions for our clients. Together, you will help our clients make critical changes to improve their performance and realize their most important goals. You will be responsible for developing and executing a variety of validation and FDA compliance related documents/protocols for pharmaceutical equipment. This person will travel to top clients across the country to assist in the design of manufacturing processes, help manage projects, develop facilities, and impact the world by conducting themselves with integrity in pursuit of individual and enterprise goals. This role will challenge you to be a passionate and successful business family member while expanding your technical abilities. Establish user requirement specification for critical equipment and systems. Assess risk across various aspects of systems' functions and focus efforts on critical quality aspects. Develop and execute validation and FDA compliance related documents/protocols for pharmaceutical equipment and processes including Process Equipment, Facility / Utilities, Cleaning / Process. Work with teams to perform investigations and troubleshoot issues related to validation. Analyze qualification data and recommend corrective actions. Develop and perform impact assessments, trace matrices, system risk assessments, and other risk-based validation documentation deliverables. Prepare validation reports. Assist in project planning, scheduling, and coordination. Provide routine communication and status updates to BW Design Group for project leadership and the client. Make an impact day-to-day with your skills and expertise, strengthening that relationship with our clients and team.

What You'll Bring

Candidates need to possess good communication and interpersonal skills, flexibility with tasks and the ability to interact with all levels of management, clients, and vendors. Ability to work as an individual contributor as well as a team player on a large project team. Minimum of 7+ years project experience in the pharmaceutical or medical device environments. Strong technical writing and oral communications. Strong computer skills (Microsoft Office, Microsoft Project, and AutoCAD). 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. Understanding of ICH Q7 through 11, 21 CFR Parts 210, 211, 11, ISPE Baseline Guides, GAMP5, and ASTME2500. B.S. in Bioengineering, Biomedical Engineering, Chemical Engineering, or related technical degree.

Our Culture

Our culture and commitment to our people is what sets us apart. We foster an environment of mutual respect, integrity, and unconditional interest in the individual and collective success of our professionals. Our model and entrepreneurial mindset offer a rewarding, challenging, and highly flexible path. As a Validation Engineer, you will build a meaningful and fulfilling career with the support of professional development resources and mentorships including our First-Year Experience program, Individual Development Plans, and Career Path resources and tools. You will be surrounded by exceptional talent who will support your development as both a world-class engineer and a highly effective leader.

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Additional Information

At Barry-Wehmiller we recognize that people come with a wealth of experience and talent beyond just the technical requirements of a job. If your experience is close to what you see listed here, please still consider applying. We know that our differences often can bring about innovation, excellence and meaningful work-therefore, people from all backgrounds are encouraged to apply to our positions.

Please let us know if you require reasonable accommodations during the interview process.

Barry-Wehmiller is an equal opportunity employer. M/F/D/V. This organization uses E-Verify. Applicants may be subject to pre-employment screening which may include drug screening, reference checks, employment verifications, background screening and/or skills assessments.

Company

Design Group Throughout Barry-Wehmiller, we hold ourselves to a unique measure of success: by the way we touch the lives of people. It's that vision that drives us in creating world-class experiences and solutions for our customers and unites us around our common goal—to use the power of our business to build a better world.