Validation Engineer II

BW Design Group; Indianapolis (IN); On-site; USD 75,000 - 110,000; Full time

Job summary

BW Design Group is seeking a Validation Engineer II to join our team in the Indianapolis area. You will develop and execute validation and FDA compliance documents for pharmaceutical equipment and processes, traveling to top clients to support design and project execution.

The role requires 3+ years in pharma/medical device environments, strong technical writing, and the ability to interact with all levels of management and clients.

Qualifications

• Excellent written and oral communication skills.
• Ability to interact with all levels of management, clients and vendors.
• Minimum 3 years of project experience in pharmaceutical or medical device environments.
• Strong technical writing and documentation abilities.
• Proficient in common software tools (Office, Project, AutoCAD).
• Willingness to travel for project requirements and client meetings.
• Understanding of ICH Q7–Q11, 21 CFR Parts 210, 211, ASAP/ASTME2500 guidelines.

Responsibilities

• Develop and execute validation and FDA compliance documents/protocols for pharmaceutical equipment.
• Travel to top clients to assist in design of manufacturing processes and project coordination.
• Establish user requirement specifications for critical equipment and systems.
• Assess risk across system functions and focus on quality critical aspects.
• Prepare validation reports and conduct investigations to troubleshoot validation issues.
• Assist in project planning, scheduling, and status communication with leadership and clients.

Skills

Communication

Teamwork

Technical writing

Interpersonal skills

Travel readiness

Cross-functional collaboration

Education

B.S. in Bioengineering/related

Tools

Microsoft Office

Microsoft Project

AutoCAD

Job description

Who You’ll Work With

You will join one of our 45 offices in the US, be part of a committed team of over 1600 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.

What You’ll Do

You’ll 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.

• 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 all 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 & 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 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 3 years project experience in the pharmaceutical or medical device environments.
• Strong technical writing and oral communications.
• Strong computer skills (Microsoft Office, Microsoft Project, & 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 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 II, 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.