Pharma Validation Engineer II — Impact & Compliance

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

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.